FARA-Free: A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Boston Scientific Corporation

F A R A -Free : 
A Si n gle Ar m Pil ot  St u d y of  
P ulse d Fiel d  A bl ati o n i n t he Tr e at me nt of 
P ar o x ys m al Atri al Fi brill ati o n  
C LI NI C A L IN V E S TI G A TI O N P L A N ( CI P) N U M B E R : C S 0 7 6 6  R E VI SI O N C  
S P O N S O R : 
F A R A P U L S E,  IN C . 
3 7 1 5  H A V E N A V E .  S UI T E 1 1 0  
M
E N L O P A R K , C A  9 4 0 2 5  
U S A  
IS S U E D A T E : 1 3  F E B R U A R Y  2 0 2 0  
T his st u dy is t o be perf or me d i n acc or d a n ce wit h G o o d Cli nic al Pr actice ( G C P), t he et hic al 
pri nci ples t h at h ave t heir ori gi n i n t he Decl ar ati o n of Helsi nki, I nter n ati o n al C o nfere nce o n 
H ar m o nis ati o n E 6 a n d A N SI / A A MI / I S O St a n d ar ds 1 4 1 5 5: 2 0 1 1 . 
T his d oc u me nt c o nt ai ns c o nfi de nti al a n d pr o priet ary i nf or m ati o n a n d m ay n ot be c o pie d or 
re pr o d uce d i n w h ole or i n p art wit h o ut t he ex press writte n per missi o n of F A R A P U L S E , IN C .,
M E N L O P A R K , C A . 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
 
 
Re visi o n Letter  C h a n ge Descri pti o n  
A  
I niti al Rele ase 
B  
•  
U p d ate d t o a d d First -i n-H u m a n F A R A D RI V E S he at h a n d re vise d 
s yste m n a me 
•  
A d de d a d diti o n al st u d y i n vesti g at or i nf or m ati o n  
•  
A d de d r oll i n s u bjects t o Secti o n 5. 6 P o p ul ati o ns f or A n al ysis  
•  
A d de d Secti o n 9. 2. 5 S h ari n g Ne w I nf or m ati o n  
C  
•  
A d diti o n of Rec or di n g  S witc h B o x as access or y t o t he F A R A S T A R 
G e ner at or 
•  
U p d ate d s yste m c o m p o ne nts fi g ure ( Fi g ure 1)  
•  
A d diti o n of Secti o n 3. 1 0. 6 –  Tre at me nt of Pre g n a ncies I de ntifie d 
D uri n g S u bject P artici p ati o n  
•  
A d de d  D oc u me nt Re visi o n Hist or y T a ble  
•  
U p d ate Fi g ure 5 –  ne w fi g ure of t he F A R A D RI V E s he at h a n d dil at or  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
 
 
T A B L E O F C O N T E N T S  
 
P RI M A R Y S T U D Y C O N T A C T S  ...............................................................................................7  
E X E C U TI V E S U M M A R Y  ......................................................................................................1 0  
A B B R E VI A TI O N S A N D A C R O N Y M S  .....................................................................................1 8  
1.  
IN T R O D U C TI O N .........................................................................................................2 0  
1. 1  
B A C K G R O U N D A N D R A TI O N A L E ..................................................................2 0  
1. 2  
IR R E V E R SI B L E E L E C T R O P O R A TI O N (I R E) ...................................................2 0  
1. 3  
S U M M A R Y O F F A R A P U L S E  C LI NI C A L S T U DI E S  ........................................2 1  
1. 3. 1  E N D O C A R DI A L A B L A TI O N S T U DI E S –  T H E I M P U L S E S T U D Y  ........2 1  
1. 3. 2  E N D O C A R DI A L A B L A TI O N S T U DI E S –  T H E P E F C A T  S T U D Y  ...........2 1  
1. 3. 3  E N D O C A R DI A L A B L A TI O N S T U DI E S –  T H E P E F C A T  II S T U D Y  .......2 2  
1. 4  
R A TI O N A L E F O R C O N D U C TI N G T HI S F E A SI BI LI T Y S T U D Y  ...........................2 2  
2.  
IN V E S TI G A TI O N A L D E VI C E S  ....................................................................................2 3  
2. 1  
N A M E S O F IN V E S TI G A TI O N A L D E VI C E S  ......................................................2 3  
2. 2  
IN T E N D E D U S E  ............................................................................................2 3  
2. 3  
C L A S SI FI C A TI O N  .........................................................................................2 3  
2. 4  
F A R A P U L S E  A B L A TI O N S Y S T E M P L U S  ....................................................2 3  
2. 4. 1  F A R A W A V E  E N D O C A R DI A L A B L A TI O N C A T H E T E R  .....................2 5  
2. 4. 2  F A R A F L E X  E N D O C A R DI A L A B L A TI O N C A T H E T E R  .......................2 7  
2. 4. 3  F A R A S T A R  G E N E R A T O R  ..............................................................2 8  
2. 4. 4  F A R A D RI V E  D E F L E C T A B L E A N D S T E E R A B L E S H E A T H S  ...............2 8  
2. 5  
D E VI C E A C C O U N T A BI LI T Y  ..........................................................................2 9  
2. 6  
R E T U R N O F D E VI C E S  ...................................................................................3 0  
3.  
S T U D Y D E S I G N .........................................................................................................3 1  
3. 1  
S T U D Y O BJ E C TI V E  ......................................................................................3 1  
3. 2  
S T U D Y O V E R VI E W  ......................................................................................3 1  
3. 3  
S U BJ E C T C O N FI D E N TI A LI T Y  ........................................................................3 1  
3. 4  
W
RI T T E N IN F O R M E D C O N S E N T  ...................................................................3 1  
3. 5  
S T U D Y E N T R Y C RI T E RI A  .............................................................................3 2  
3. 5. 1  IN C L U SI O N C RI T E RI A  ......................................................................3 2  
3. 5. 2  E X C L U SI O N C RI T E RI A  .....................................................................3 3  
3. 6  
E N R O L L M E N T  ..............................................................................................3 4  
3. 7  
S A M P L E S I Z E ...............................................................................................3 4  
3. 8  
IN V E S TI G A TI O N A L S I T E S .............................................................................3 5  
3. 9  
D U R A TI O N O F S U BJ E C T P A R TI CI P A TI O N  ......................................................3 5  
3. 1 0  
S U BJ E C T C O M P L E TI O N O R W
I T H D R A W A L ...................................................3 5  
3. 1 0. 1  S T U D Y C O M P L E TI O N  .......................................................................3 5  
3. 1 0. 2  V O L U N T A R Y W
I T H D R A W A L ...........................................................3 5  
3. 1 0. 3  IN V E S TI G A T O R INI TI A T E D WI T H D R A W A L  ........................................3 5  
3. 1 0. 4  D O C U M E N T A TI O N  ...........................................................................3 5  
3. 1 0. 5  C O N TI N UI N G M E DI C A L C A R E  .........................................................3 5  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 4  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
3. 1 0. 6  T R E A T M E N T O F P R E G N A N CI E S ID E N TI FI E D D U RI N G S U BJ E C T 
P A R TI CI P A TI O N  ...............................................................................3 5  
3. 1 0. 7  L O S T T O F O L L O W -U P  ......................................................................3 5  
3. 1 1  
P R O C E D U R E S  ..............................................................................................3 6  
3. 1 1. 1  IN D E X P R O C E D U R E  .........................................................................3 6  
3. 1 1. 2  R E A B L A TI O N P R O C E D U R E  ...............................................................3 7  
3. 1 1. 3  B L A N KI N G P E RI O D  ..........................................................................3 7  
3. 1 1. 4  A R R H Y T H MI A C O R E L A B  ................................................................3 7  
3. 1 2  
S C H E D U L E O F E V E N T S A N D A S S E S S M E N T S  .................................................3 8  
3. 1 2. 1  B A S E LI N E  ........................................................................................3 8  
3. 1 2. 2  IN D E X P R O C E D U R E  .........................................................................3 8  
3. 1 2. 3  P R E -D I S C H A R G E .............................................................................3 9  
3. 1 2. 4  7 -D A Y  T E L E P H O N E A S S E S S M E N T ....................................................3 9  
3. 1 2. 5  3 0 -D A Y V I SI T .................................................................................3 9  
3. 1 2. 6  R E A B L A TI O N P R O C E D U R E  ...............................................................4 1  
3. 1 2. 7  9 0 -D A Y V I SI T .................................................................................4 2  
3. 1 2. 8  6 -M O N T H  V I SI T ..............................................................................4 2  
3. 1 2. 9  1 2 -M O N T H V I SI T ............................................................................4 3  
3. 1 2. 1 0  U N S C H E D U L E D V I SI T S ................................................................4 3  
3. 1 2. 1 1  N E U R O L O GI C A S S E S S M E N T S U B P O P U L A TI O N  .............................4 4  
3. 1 3  
S C H E D U L E O F S T U D Y A S S E S S M E N T S  ..........................................................4 5  
4.  
B E N E FI T R I S K A S S E S S M E N T  ....................................................................................4 6  
4. 1  
P O T E N TI A L A D V E R S E E V E N T S  ....................................................................4 6  
4. 2  
P O T E N TI A L R I S K S .......................................................................................4 7  
4. 3  
P O T E N TI A L B E N E FI T S ..................................................................................4 8  
5.  
S T A TI S TI C A L A N A L Y SI S A N D R E P O R TI N G  ...............................................................4 9  
5. 1  
G E N E R A L S T A TI S TI C A L C O N SI D E R A TI O N S  ..................................................4 9  
5. 2  
C O N T R O L O F S Y S T E M A TI C E R R O R A N D B I A S ..............................................4 9  
5. 3  
S A M P L E S I Z E JU S TI FI C A TI O N  ......................................................................4 9  
5. 4  
S U BJ E C T D I S P O SI TI O N .................................................................................5 0  
5. 5  
IM P U T A TI O N F O R M I S SI N G D A T A  ................................................................5 0  
5. 6  
P O P U L A TI O N S F O R A N A L Y SI S  .....................................................................5 0  
5. 7  
F I N A L C LI NI C A L R E P O R T  ............................................................................5 0  
6.  
O U T C O M E M
E A S U R E S  ..............................................................................................5 1  
6. 1  
P RI M A R Y S A F E T Y E N D P OI N T  ......................................................................5 1  
6. 2  
A D DI TI O N A L S A F E T Y A N A L Y S E S  ................................................................5 3  
6. 3  
P RI M A R Y E F F E C TI V E N E S S E N D P OI N T  ..........................................................5 3  
6. 4  
A D DI TI O N A L E F F E C TI V E N E S S A N A L Y S E S ....................................................5 3  
6. 5  
P R O C E D U R A L A S S E S S M E N T S .......................................................................5 3  
7.  
A D V E R S E E V E N T S , D E VI C E E F F E C T S , M
A L F U N C TI O N S A N D D E FI CI E N CI E S  ..........5 5  
7. 1  
A D V E R S E E V E N T S  .......................................................................................5 5  
7. 2  
S E RI O U S A D V E R S E E V E N T S  ........................................................................5 5  
7. 3  
D E VI C E E F F E C T S  .........................................................................................5 6  
7. 3. 1  A D V E R S E D E VI C E E F F E C T S  .............................................................5 6  
7. 3. 2  S E RI O U S A D V E R S E D E VI C E E F F E C T S  ..............................................5 6  
7. 3. 3  U N A N TI CI P A T E D S E RI O U S A D V E R S E D E VI C E E F F E C T S  ...................5 6  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 5  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
7. 4  
D E VI C E D E FI CI E N CI E S  .................................................................................5 6  
7. 5  
U S E E R R O R S  ...............................................................................................5 6  
7. 6  
M A L F U N C TI O N S  ..........................................................................................5 7  
7. 7  
C A U S A LI T Y R E L A TI O N S HI P  .........................................................................5 7  
7. 8  
R E P O R TI N G  .................................................................................................5 8  
8.  
M
O NI T O RI N G  ............................................................................................................6 0  
9.  
S T U D Y M
A N A G E M E N T  .............................................................................................6 2  
9. 1  
K E Y C O N T RI B U T O R S  ...................................................................................6 2  
9. 1. 1  S T U D Y S P O N S O R  .............................................................................6 2  
9. 1. 2  C R O  ...............................................................................................6 2  
9. 1. 3  A R R H Y T H MI A C O R E L A B  ................................................................6 2  
9. 2  
E T HI C A L C O N SI D E R A TI O N S  .........................................................................6 2  
9. 2. 1  S T U D Y C O N D U C T  ............................................................................6 3  
9. 2. 2  E T HI C S R E VI E W  ..............................................................................6 3  
9. 2. 3  IN F O R M E D C O N S E N T  .......................................................................6 3  
9. 2. 4  C O V E R A G E O F E X P E N S E S  ................................................................6 3  
9. 2. 5  S H A RI N G N E W IN F O R M A TI O N  .........................................................6 3  
9. 2. 6  C O N FI D E N TI A LI T Y  ..........................................................................6 3  
9. 3  
IN S U R A N C E  .................................................................................................6 4  
9. 4  
A U DI T S A N D IN S P E C TI O N S  ..........................................................................6 4  
9. 5  
S P O N S O R R E S P O N SI BI LI TI E S  ........................................................................6 4  
9. 6  
M O NI T O R R E S P O N SI BI LI TI E S  .......................................................................6 5  
9. 7  
IN V E S TI G A T O R R E S P O N SI BI LI TI E S  ...............................................................6 6  
9. 8  
IN V E S TI G A T O R T R AI NI N G  ...........................................................................6 7  
9. 9  
S I T E T R AI NI N G  ............................................................................................6 8  
9. 1 0  
C LI NI C A L E V E N T S A N D D A T A M O NI T O RI N G C O M MI T T E E  ...........................6 8  
9. 1 1  
D A T A M A N A G E M E N T  ..................................................................................6 8  
9. 1 2  
S T U D Y S U S P E N SI O N O R E A R L Y T E R MI N A TI O N  ............................................6 9  
9. 1 3  
C RI T E RI A F O R S U S P E N DI N G / T E R MI N A TI N G A S T U D Y C E N T E R  ...................6 9  
9. 1 4  
D E VI A TI O N S F R O M T H E C LI NI C A L IN V E S TI G A TI O N P L A N  ............................6 9  
1 0.  R E G U L A T O R Y C O N SI D E R A TI O N S  .............................................................................7 1  
1 0. 1  
M AI N T AI NI N G R E C O R D S  .............................................................................7 1  
1 0. 2  
D A T A H A N D LI N G A N D R E C O R D K E E PI N G  ...................................................7 1  
1 0. 2. 1  S O U R C E D O C U M E N T S  .....................................................................7 1  
1 0. 2. 2  D A T A C O L L E C TI O N  .........................................................................7 1  
1 0. 3  
E T HI C S C O M MI T T E E A N D C O M P E T E N T A U T H O RI T Y A P P R O V A L  ..................7 2  
1 0. 4  
P R O C E D U R E F O R A M E N DI N G T H E CI P  .........................................................7 2  
T H E P R O C E S S O F A M E N DI N G T H E CI P  A N D /O R R E L A T E D D O C U M E N T S I S T H E 
R E S P O N SI BI LI T Y O F T H E S P O N S O R .  T H E P R O C E D U R E F O R A M E N DI N G T H E CI P  
S H A L L B E A S F O L L O W S : ...............................................................................7 2  
1 0. 5  
D E VI C E A C C O U N T A BI LI T Y  ..........................................................................7 2  
1 1.  P U B LI C A TI O N P O LI C Y  ..............................................................................................7 3  
1 2.  B I B LI O G R A P H Y .........................................................................................................7 4  
 
 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 6  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
 
LI S T O F T A B L E S  
 
Ta ble 1 . 
F A R A P U L S E A blati o n S yste m  Pl us  –  C o m p o ne nts  ...................................... 2 4  
Ta ble 2 . 
C E Mar ke d De vi ces Utilize d i n C o nj u ncti o n wit h F A R A P U L S E S yste m ..... 2 4  
Ta ble 3 . 
S u m mar y of St u d y Assess me nts  ..................................................................... 4 5  
Ta ble 4 . 
C o m p osite Safet y E n d p oi nt Defi niti o ns  ......................................................... 5 1  
 
 
 
 
LI S T O F FI G U R E S  
 
Fi g ure 1 . 
F A R A P U L S E A blati o n S yste m  C o m p o ne nts  ..................................................2 5  
Fi g ure 2 . 
F A R A W A V E E n d ocar di al A blati o n Cat heter  .................................................2 6  
Fi g ure 3 . 
F A R A W A V E E n d ocar di al A blati o n Cat heter  Detail  ......................................2 7  
Fi g ure  4 . 
F A R A F L E X E n d ocar dial A blati o n Cat heter  ...................................................2 9  
Fi g ure 5  
F A R A D RI V E Steera ble a n d Deflecta ble S heat hs a n d Dilat ors … … … … …. 2 8  
 
 
 
 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 7  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
Pri m ar y St u d y C o nt acts  
 
S P O N S O R  
F A R A P U L S E , I nc. 
3 7 1 5 Ha ve n A ve .  S uite 1 1 0  
Me nl o Par k, C A 9 4 0 2 5, U S A  
Tel: + 1 6 5 0  4 2 2 3 6 3 3  
 
P RI N CI P A L IN V E S TI G A T O R  
 
 
 
Pr. Petr Ne uzil  
Ne m oc nice Na H o m olce  
R oe nt ge n o va 2  
Pra g ue 1 5 0 3 0  
Czec h Re p u blic  
Tel: + 4 2 0 2 5 7 2 7 2 2 1 1  
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 8  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
A D DI TI O N A L 
IN V E S TI G A T O R S  
Dr. A nte A nic  
K B C S plit  
S pi nčiće va ul. 1, 2 1 0 0 0  
S plit, Cr oatia  
Tel: + + 3 8 5 2 1 5 5 6 1 1 1  
 
 
Pr. Pierre Jais  
H o pital car di ol o gi q ue d u Ha ut -Le v e q ue  
A ve n ue de M a gella n  
3 3 6 0 0 Pessac  
Tel: + 3 3 5 5 7 6 2 3 1 7 2  
 
 
Dr. T o m De P otter  
O L V Z Aalst  
M o orsel baa n 1 6 4  
9 3 0 0 Aalst  
Bel gi u m  
Tel: + 3 2 4 9 6 2 8 8 3 6 1  
 
 
D r. Mattias D u ytsc hae ver 
A Z Si nt -Ja n 
R u d ders h o ve 1 0  
8 0 0 0 Br u ges, Bel gi u m  
+ 3 2 5 0 4 5 2 1 1 1  
 
 
Pr. J osef Ka utz ne r 
I K E M 
Vi de ns ka 1 9 5 8/ 9  
1 4 0 2 1 Pra g ue 4  
Czec h Re p u blic  
Tel: + 4 2 0 2 3 6 0 5 1 1 1 1  
 
C LI NI C A L R E S E A R C H 
O R G A NI Z A TI O N  
Me d Pass I nt er nati o nal S A S  
9 5 b B o ule var d Pereir e  
7 5 0 1 7  Paris ,  
Fra n ce  
Tel: + 3 3 ( 0) 1 4 2 1 2 8 3 3 0  
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 9  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
L E G A L R E P R E S E N T A TI V E  
M P L R S A S  
9 5 bis B o ule var d Pereire  
7 5 0 1 7 Paris  
Fra n ce  
Tel: + 3 3 ( 0) 1 4 2 1 2 8 3 3 0  
 
E C G  C O R E L A B  
M D T –  Me dical D ata Tra nsfer, s.r. o.  
Za br d o vic ka 2, 6 1 5 0 0 Br n o  
Czec h Re p u blic  
C o ntact: Ver o ni ka B ol k o va  
Tel: + 4 2 0 7 2 5 0 6 9 1 9 5  
i o wa @ m dte k g.cz 
 
 
 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 1 0  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
E xec uti ve S u m m ar y  
S P O N S O R N A M E : 
F A R A P U L S E , I nc. 
T I T L E O F S T U D Y : 
F A R A -Free :  A Si n gle Ar m Pil ot  St u d y of P ulse d Fiel d  A blati o n i n 
t he Treat me nt of Par o x ys mal Atrial Fi brillati o n  
CI P  N U M B E R  / 
R E VI SI O N :  
C S 0 7 6 6  Re visi o n C   
O B J E C TI V E : 
T he o bjecti ve of t his pil ot st u d y is t o c o nfir m t hat  e n d ocar di al 
a blati o n usi n g t he F A R A P U L S E A blati o n S yste m  Pl us  wit h 
c o m mercial desi g n d e vices is b ot h  safe a n d effecti ve  f or treati n g 
dr u g -resista nt par o x ys mal atrial fi brillati o n ( P A F). 
C LI NI C A L 
H Y P O T H E SI S : 
P ul m o nar y vei n is olati o n ( P VI) a n d relate d a blati o ns creat e d b y  t he 
F A R A P U L S E A blati o n S yste m Pl us  are a safe a n d effecti ve 
treat me nt f or dr u g resista nt par o x ys mal  atrial fi brillati o n ( A F). 
N A M E O F 
IN V E S TI G A TI O N A L 
D E VI C E : 
F A R A P U L S E A blati o n S yste m Pl us  (c o m mercial desi g n) 
•  F A R A W A V E ™ E n d ocar dial A blati o n Cat heters   
•  F A R A F L E X ™ E n d ocar dial A blati o n Cat heter  
•  F A R A S T A R ™ E n d ocar dial Ge nerat or  
•  
F A R A D RI V E ™ Steera bl e  S heat h  
•  
F A R A D RI V E ™ Deflect a ble  S heat h  
S T U D Y O V E R VI E W : 
T his is a p r os pecti ve, m ulti -ce nter, si n gle ar m safet y a n d 
effecti ve ness pil ot  st u d y.  S u bjects will u n der g o perc uta ne o us P F A  
a blati o n f or p ul m o nar y vei n is olati o n  a n d at t he cli nical discreti o n 
of t he i n vesti gat or recei v e P F A  a blati o n of a d diti o nal 
arr h yt h m o ge nic l ocati o ns . S u bjects will be f oll o we d at 7  da ys  
(tele p h o nic), 3 0 d a ys, 9 0  da ys , 6 m o nt hs a n d 1 2 m o nt hs f or a d verse 
e ve nts, rec urre nce of arr h yt h mia after a 9 0 -da y Bla n ki n g Peri o d  
a n d ot her rele va nt o utc o me meas ures.  
S T U D Y 
P O P U L A TI O N : 
S u bjects wit h d oc u me nte d dr u g -resista nt ( Class I-I V) s y m pt o matic 
P A F w h o ha ve h a d ≥ 2 e pis o des wit hi n 6 m o nt hs of e nr oll me nt.  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 1 1  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
P L A N N E D 
E N R O L L M E N T : 
U p t o 5 0  s u bjects at u p t o 6  E ur o pea n  ce nters wit h n o m ore t ha n 1 5 
s u bjects bei n g e nr olle d at a n y o ne site. 
T w o ( 2)  s u bjects at eac h ne w site ma y be r oll i n s u bjects, re p orte d 
b ut n ot i ncl u de d i n pil ot a nal ysis .  All safet y a n d effecti ve ness  
res ults fr o m r oll i n patie nts will be f ull y re p orte d i n cli nical st u d y 
re p orts, b ut effecti ve n ess res ults fr o m t hese patie nts will n ot be 
i ncl u de d i n statistical calc ulati o n of per pr ot o c ol e n d p oi nts.  
5 0 s u bjects wit h a tar gete d e nr oll me nt of at least 3 0 at ne w sites  
w hic h ha ve n ot use d a P F A s yste m bef ore , utilizi n g t he u p date d 
c o m mercial desi g n i n vesti gati ve de vices all o ws assess me nt of t he 
re vise d de vices, c o nfir ms trial para meters a n d pr o vi des fee d b ac k o n 
t he trai ni n g a n d o versi g ht of ne w i n vesti gat ors. T he f oll o wi n g sites 
will n ot ha ve perf or m e d P F A a blati o n usi n g a F A R A P U L S E 
s yste m at t he ti me of e nr oll me nt i n t his trial: 
 
Dr. Mattias D u ytsc hae ver  
A Z Si nt -Ja n 
R u d ders h o ve 1 0  
8 0 0 0 Br u ges, Bel gi u m  
+ 3 2 5 0 4 5 2 1 1 1  
 
 
Pr. J osef Ka utz ner  
I K E M 
Vi de ns ka 1 9 5 8/ 9  
1 4 0 2 1 Pra g ue 4  
Czec h Re p u blic  
Tel: + 4 2 0 2 3 6 0 5 1 1 1 1  
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 1 2  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
D E SI G N : 
Pr os pecti ve, si n gle ar m, o pe n la bel, m ulti -ce nter pil ot st u d y 
utilizi n g t he F A R A P U L S E A blati o n S yste m Pl us  t o treat s u bjects 
wit h P A F.  
S u bjects will u n der g o perc uta ne o us a blati o n f or p ul m o nar y vei n 
is olati o n a n d p ote ntial C TI a n d a d diti o nal lesi o ns.  
A si n gle re -a bl ati o n wit h t he e x peri me ntal d e vices d uri n g t he 
bla n ki n g peri o d (t hr o u g h Da y 9 0) is per mitte d b ut d oes n ot e xte n d 
eit her t he bla n ki n g peri o d  or t he t otal f oll o w -u p i nter val.  
S afet y:  S u bjects  will t he n be f oll o we d at 7 da ys (tele p h o nic), 3 0 
da ys, 9 0 da ys , 6 m o nt hs a n d 1 2 m o nt hs  f or a d verse e ve nts. A 
c o m p osite de vice a n d pr oce d ure relat e d S A E rate  will be re p orte d 
a n d c o m pare d t o a perf or ma nce g oal.  
Effecti v e ness:  S u bjects will be m o nit ore d wit h wee kl y sc he d ul e d 
a n d s y m pt o m -d ri ve n u nsc he d ule d e ve nt m o nit ori n g, as well as 6 a n d 
1 2 -m o nt h 2 4 h o ur H olter m o nit ori n g, f or rec urre nce of arr h yt h mia 
after a 9 0 da y bl a n ki n g peri o d. T he free d o m fr o m rec urre nt atrial 
tac h yarr h yt h mias ( A T A) t hr o u g h 1 2 m o nt hs  will be re p orte d a n d 
c o m pare d t o a p erf or ma n ce g oal . 
D U R A TI O N O F 
S U B J E C T 
P A R TI CI P A TI O N : 
Site i nitiati o n a n d i n vesti gat or trai ni n g is esti mate d t o ta ke 3 
m o nt hs. T he e nr oll me nt peri o d is esti mate d t o ta ke 4 m o nt hs a n d 
s u bjects will be f oll o we d f or u p t o 1 3 m o nt hs.   
Pr oce d ural a n d 7 -da y d ata f or re g ulat or y s u b missi o n s h o ul d be 
a vaila ble a p pr o x i matel y 5 m o nt hs after first e nr oll me nt. 
T he t otal st u d y d urati o n will be a p pr o xi matel y 2 0 m o nt hs fr o m t he 
be gi n ni n g of site trai ni n g t o fi nal st u d y f oll o w -u p.  
P L A N N E D 
P R O C E D U R E S : 
P VI: S u bjects will u n der g o a n atte m pt t o is olate all p ul m o nar y 
vei ns or t heir a nat o mic e q ui vale nt.  
C TI: S u bject s wit h a past hist or y of atrial fl utter, w h o are at ris k of 
atrial fl utter, w h o prese nt wit h atrial fl utter d uri n g t he I n d e x 
Pr oce d ure  or  w h o ha v e i nd uci ble ca v o-tric us pi d ist h m us-me diate d  
(t y pical) fl utter ma y u n d er g o a blati o n of t he ca v o -tric us pi d ist h m us 
at t he discreti o n of t he i n vesti gat or.  
Ot her: A d diti o nal lesi o ns ma y be ma de at t he dis creti o n of t he 
i n vesti gat or t o tar get f ocal sites a n d/ or electrical g a ps f oll o wi n g 
atte m pte d p ul m o nar y vei n is olati o n. 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 1 3  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
P RI M A R Y S A F E T Y 
E N D P OI N T : 
T he pri mar y safet y e n d p oi nt f or t his st u d y is t he C o m p osite Safet y 
E n d p oi nt ( C S E) defi ne d as t he i nci de nce of t he f oll o wi n g seri o us 
a d verse e ve nts ( S A Es) w hic h are d e vice - or pr o ce d ure -relate d, as 
a dj u dicate d b y t he C E D M C  base d o n t he defi niti o ns c o ntai ne d i n 
t he C o m p osite Safet y E n d p oi nt Defi niti o ns  Ta ble  4 .  
Earl y o nset ( wit hi n 7  da ys of a n  in de x  or pr ot o c ol -s pecifie d 
rea blati o n p r oce d ure) 
•  Deat h  
•  M y ocar dial i nfarcti o n  
•  Persiste nt dia p hra g matic paral ysis  
•  Str o ke  
•  T ra nsie nt isc he mic attac k  
•  Peri p heral or or ga n t hr o m b oe m b olis m  
•  Pericar di al eff usi o n, he m orr ha ge or  ta m p o na de 
•  Vasc ular access c o m plicati o ns  
•  H os pitalizati o n   
•  Heart bl oc k  
Late o nset (a n y ti me d uri n g f oll o w -u p)  
•  P ul m o nar y vei n ste n osis  
•  
Atri o -es o p ha geal fist ula  
P S E  S T A TI S TI C S  
T he pr o p orti o n of st u d y s u bjects wit h o ne or m ore P S Es will be 
re p orte d a n d c o m pare d d escri pti vel y t o hist orical data. 
A D DI TI O N A L  
S A F E T Y A N A L Y S E S : 
T he pr o p orti o n of s u bjects : 
1.  Wit h a n y a d verse e v e nt i n t he C o m p osite Safet y E n d p oi nt 
defi niti o ns ta ble, w het her or n ot a dj u dicate d as a n S A E  
2.  Wit h  a de vice - or pr o ce d ure -relate d S A E 
3.  Wit h a de vice - or pr o ce d ure -relate d str o ke or TI A 
4.  Wit h a pre -p ost cra nial M RI c h a n ge ( brai n i ma gi n g 
s u b p o p ulati o n) 
5.  R e q uiri n g car di o versi o n  
6.  R e q uiri n g a n arr h yt h mia -relate d h os pitalizati o n 
Lear ni n g c ur ve a n al ysis . 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 1 4  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
P RI M A R Y 
E F F E C TI V E N E S S  
E N D P OI N T : 
T he pr o p orti o n of s u bjects wit h : 
•  Ac ute Pr oce d ural S uccess, A N D  
•  T hera p e utic S uccess, d efi ne d as free d o m fr o m:  
o  P ost  bla n ki n g peri o d  t hr o u g h assess me nt: occ urre n ce of 
A F, A F L or A T, or a blati o n f or A F/ A F L/ A T usi n g t he 
st u d y de vice 
o  At a n y ti me: a blati o n f or A F/ A F L/ A T wit h a n o nst u d y 
de vice  
T hera p e utic s uccess will be assesse d b et wee n Da y 9 1  a n d t he 1 2 
m o nt h ± 4 wee k f oll o w -u p visit . 
A D DI TI O N A L  
E F F E C TI V E N E S S  
A N A L Y S E S : 
 
1.  Ac ute Pr oce d ural S uccess, defi ne d as t he p erc ut a n e o us 
e n d ocar di al creati o n  of a n electricall y is olati n g set of lesi o ns 
ar o u n d t he ostia of p ul m o nar y vei ns ( P V) d uri n g t he i n de x 
pr oce d ure, as cli nicall y assesse d b y e ntra n ce a n d/ or e xit bl oc k 
perf or me d ≥ 2 0 mi n utes after t he l ast P VI l esi o n is ma de o n a 
per patie nt basis.  
2.  T he pri mar y effecti ve ness e n d p oi nt f or s u bjects n ot o n A F Ds 
bet wee n Da y 1 0 5 a n d t he 1 2 m o nt h f oll o w -u p visit.  
3.  First pass is olati o n (i n de x pr oce d ure)  c o nsisti n g of Ac ute 
Pr oce d ural S uccess after a si n gle pla n ne d set of lesi o ns i n 
eac h atte m pte d P V  
4.  T he pr o p orti o n of s u bjects wit h earl y rec urre nce of atrial 
fi brillati o n ( E R A F) b y 9 0 da ys after t h e i nitial st u d y a blati o n 
5.  T he pr o p orti o n of atte m pte d s u bjec ts t hat ac hie ve Ac ute  C TI 
S uccess, defi n e d as t he creati o n of bi -dir ecti o nal electrical 
bl oc k acr oss t he  ca v o-tri c us pi d ist h m us usi n g t he 
i n vesti gati o nal de vices. 
6.  Lear ni n g c ur ve a n al ysis  
7.  Rate of a n y rea blati o n t hr o u g h 1 2 m o nt hs of f oll o w -u p  
P R O C E D U R A L 
A S S E S S M E N T S : 
 
1.  Assess me nts of d urati o n f or pr oce d ure c o m p o ne nts  
a. Pr oce d ure ti me ( i nitiati o n of ve n o us access t o ve n o us 
access cl os ure ). 
b.  D well ti me (s u m of cat heter e ntr y -t o-e xit d urati o ns ). 
c. T otal a blati o n ti me (first a blati o n t o last a blati o n)  
d.  Fl u or osc o p y ti me (t otal d urati o n of e x p os ure) . 
2.  C haracterizati o n of lesi o n sets : 
a. P VI a blati o ns  
b.  E xtra -P V  a blati o ns , e x cl u di n g C TI a blati o ns  
c. C TI a bl ati o ns  
d.  A n o mal o us P V a blati o ns  
Q U A LI T Y O F L I F E 
M
E A S U R E S  
S u bjects will u n der g o assess me nt wit h t he E Q -5 D -3 L i nstr u me nt  
at baseli ne a n d 1 2 m o nt hs . 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 1 5  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
IN C L U SI O N 
C RI T E RI A : 
St u d y s u bjects are re q uire d t o meet all t he f oll o wi n g i ncl usi o n 
criteria t o partici pate i n t his st u d y:  
 
1.  Patie nts wit h d oc u me nte d dr u g  resista nt s y m pt o matic P A F 
meeti n g all t hree of t he f oll o wi n g criteria:  
a. C o nfir me d A F: D o c u me ntati o n ma y  i ncl u de a 
rec or di n g s uc h as E C G, tra nstele p h o nic m o nit or 
( T T M), H olter m o nit or, i m pla nte d de vices, or t ele metr y 
stri p, rec or de d wit hi n o ne year pri or t o e nr oll me nt a n d 
s h o wi n g at least 3 0 sec o n ds of A F. 
b.  Fre q u e nt A F, d efi ne d as ≥ 2 e pis o des wit hi n 6 m o nt hs 
of e nr oll me nt.  
c. Faile d atri al fi brillati o n dr u g ( A A D ) treat me nt, 
mea ni n g t hera p e utic fail ure of at least o ne A A D  (class I 
–  I V) f or effi cac y a n d / or i nt olera nce. 
2.  Patie nts w h o are ≥ 1 8 a n d ≤ 7 5 years of a ge o n t he da y of 
e nr oll me nt.  
3.  Patie nt partici pati o n re q uire me nts:  
a. Li ves l ocall y.  
b.  Is willi n g a n d ca pa ble of pr o vi di n g I nf or me d C o ns e nt t o 
u n der g o st u d y pr oce d ures.  
c. Is willi n g t o partici pate i n all e xa mi nati o ns a n d f oll o w -u p 
visits a n d tests ass ociate d wit h t his cli nical st u d y.  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 1 6  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
E X C L U SI O N 
C RI T E RI A : 
S u bjects will be e xcl u de d fr o m partici pati n g i n t his st u d y if t he y meet 
a n y o ne of t he f oll o wi n g e xcl usi o n criteria:  
 
1.  Atrial fi brillati o n t hat is a n y of t he f oll o wi n g: 
a. Persiste nt ( b y dia g n osis or c o nti n u o us d urati o n > 7 da ys)  
b.  Sec o n dar y t o electr ol yte i m bala nce, t h yr oi d diseas e, 
alc o h ol or ot her re versi ble / n o n -car diac ca uses  
c. Re q uires ≥ 4 car di o v ersi o ns i n t he prece di n g 1 2 m o nt h s 
2.  Left atrial a nt er o p osteri or dia meter ≥ 5. 0 c m as d o c u me nte d b y 
tra nst h oracic ec h o car di o gra p h y ( T T E) or c o m p ut e d t o m o gra p h y 
( C T) 
3.  At a n y ti me, o ne or m ore  of t he f oll o wi n g car di ac pr oce d ures, 
i m pla nts or c o n diti o ns: 
a. Cli nicall y si g nifica nt arr h yt h mias ot her t ha n A F, A F L or 
A T  
b.  A n y pre vi o us e n d ocar dial or e picar di al a blati o n or s ur ger y 
f or A F 
c. He m o d y na micall y si g nifica nt val v ular dise ase  
d.  A n y pr ost hetic  heart va l v e  
e. Heart fail ure –  a n y of t he f oll o wi n g:  
i. N Y H A Class III or I V C H F  
ii. L V E F < 4 0 %  
iii. Heart fail ure h os pitalizati o n  
f. Atrial or ve ntric ular se pt al defect cl os ure  
g.  Atrial m y x o ma  
h.  Left atrial t hr o m b us  
i. Left atrial a p pe n da g e de vice or occl usi o n  
j. Pace ma ker, i m pla nta ble car d i o verter defi brillat or or 
car diac res y n c hr o nizati o n t hera p y de vices  
k.  Si g nifica nt or s y m pt o matic h y p ote nsi o n  
l. Bra d ycar di a or c hr o n otr o pic i nc o m pete nce  
m.  Hist or y of pericar ditis  
n.  Hist or y of r he u matic fe v er  
o.  Hist or y of c o n ge nital heart disease wit h a n y resi d ual 
a nat o mic or c o n d u cti o n a b n or malit y  
p.  A n y p ul m o nar y vei n a b n or malit y, ste n osis or ste nti n g  
4.  A n y of t he f oll o wi n g car di o vasc ular pr oce d ures, i m pla nts or 
c o n diti o ns wit hi n t he s pecifie d i nter val r elate d t o t he date of 
e nr oll me nt:  
a. Wit hi n t he 3 m o nt hs pre ce di n g e nr oll me nt:  
i. M y ocar dial i nfarcti o n  
ii. U nsta ble a n gi na  
iii. Perc uta ne o us c or o nar y i nter ve nti o n  
i v. Treat me nt wit h a mi o dar o ne  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
P A G E 1 7  
C O N FI D E N TI A L 
© 2 0 2 0 , F ar a p ulse, I nc. 
E X C L U SI O N
C RI T E RI A
(C O N TI N U E D ): 
b.
Wit hi n t he 6 m o nt hs prece di n g e nr oll me nt:
i. Heart s ur g er y
ii. Str o ke or TI A
iii. A n y t hr o m b oe m b olic e ve nt
i v. Car oti d ste nti n g or e n darterect o m y
v.
Pericar ditis or peri car di al eff usi o n
c.
Wit hi n t he 1 2 m o nt hs f oll o wi n g e nr oll me nt:
i. A n y li keli h o o d of car diac s ur ger y or
tra ns pla nt
5.
Hist or y of bl o o d cl otti n g or blee di n g a b n or m alities
6.
C o ntrai n dicati o n t o, or u n willi n g ness t o use, s yste mic
a ntic oa g ulati o n
7.
C o ntrai n dicati o ns t o  b ot h  C T a n d M RI
8.
Se nsiti vit y t o c o ntrast me dia n ot c o ntr olle d b y
pre me dicati o n
9.
W o me n of c hil d beari n g p ote ntial w h o are pre g na nt,
lactati n g, n ot usi n g birt h c o ntr ol or pla n ni n g t o bec o me
pre g na nt d uri n g t he a ntici pate d st u d y peri o d
1 0. Me dical c o n diti o ns t hat w o ul d pre ve nt partici pati o n i n t he
st u d y, i nterfere wit h assess me nt or t hera p y, si g nifi ca ntl y
raise t he ris k of st u d y partici pati o n, or c o nf o u n d d ata or its
i nter pretati o n, i ncl u di n g b ut n ot li mite d t o:
a.
B o d y mass i n de x ( B MI) > 4 0
b.
S oli d or ga n or he mat ol o gic tra ns pla nt, or c urre ntl y
bei n g e val uate d f or a n or ga n tra ns pla nt
c.
Se vere l u n g diseas e, p ul m o nar y h y perte nsi o n, or a n y
l u n g disease i n v ol vi n g a b n or mal bl o o d gases or
si g nifica nt d ys p nea
d.
Re nal  i ns ufficie nc y wit h a n esti mate d creati ni ne
cleara nce < 3 0 m L/ mi n/ 1. 7 3 m 2 , or a n y hist or y of
re nal dial ysis or re n al tra ns pla nt
e.
Acti ve mali g na nc y or hist or y of treate d ca n cer
wit hi n 2 4 m o nt hs of e nr oll me nt
f.
Cli nicall y si g nifica nt gastr oi ntesti nal pr o ble ms
i n v ol vi n g t he es o p ha g us, st o mac h a n d/ or u ntreate d
aci d refl u x
g.
Cli nicall y si g nifica nt i nfecti o n
h.
Pre dicte d life e x p ecta nc y less t ha n o ne year
1 1. Cli nicall y si g nifica nt ps yc h ol o gical c o n diti o n t hat i n t he
i n vesti gat or’s o pi ni o n w o ul d pr o hi bit t he s u bject's a bilit y t o
meet t he pr ot oc ol r e q uire me nts.
1 2. C urre nt or a ntici pate d e nr oll me nt i n a n y ot her cli nical st u d y.

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 1 8  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
A b bre vi ati o ns  a n d Acr o n y ms  
A C L  
Arr h yt h mia C ore La b  
A C T  
Acti vate d cl otti n g ti me  
A D E  
A d verse d e vice effect  
A E  
A d verse E v e nt  
A F  
Atrial fi brillati o n 
A F D  
Atrial Fi brillati o n Dr u g  
A F L  
Atrial fl utter  
A P S  
Ac ute P r oce d ural S uccess  
A T  
Atrial tac h ycar dia  
B MI  
B o d y Mass I n d e x  
C A  
C o m pete nt A ut h orit y  
C B C  
C o m plete bl o o d c o u nt  
C E D M C  Cli nical E ve nts a n d Data M o nit ori n g C o m mittee  
C H A 2D S 2-V A Sc     Ter me d “ C H A D S -V A S C” a cli nical pre dicti o n r ule f or str o ke  
C H F  
C o n gesti ve heart fail ure  
CI P  
Cli nical I n vesti gati o n Pla n  
C P S  
C hr o nic P r oce d ural S uccess  
C R F  
I n cl u des C R F (case re p ort f or m) a n d e C R F (electr o nic case re p ort f or m) 
C R O  
Cli nical researc h or ga ni zati o n  
C S E  
C o m p osite Safet y E n d p oi nt  
C T  
C o m p ute d t o m o gra p h y  
C TI  
Ca v o -tric us pi d ist h m us 
D C C V  
Direct c urre nt c ar di o versi o n  
E C  
Et hics C o m mittee  
E C G  
Electr ocar di o gra m  
E R A F  
E arl y rec urre nce of atrial fi brillati o n  
I C F 
I nf or me d C o nse nt F or m 
I N R 
I nter nati o nal n or malize d rati o 
I V C 
I nferi or v e na ca va 
L A  
Left atri u m  or left atrial  
MI  
M y ocar dial i nfarcti o n  
M RI  
Ma g netic res o n a nce i ma gi n g  
N O A C  
N o vel oral a ntic o a g ula nt  
NI H S S  
Nati o nal I nstit utes of Healt h Str o ke Scale  
N Y H A  
Ne w Y or k Heart Ass ociati o n  
P A F  
Par o x ys mal atrial fi brillati o n  
P F A  
P ulse d Fiel d A blati o n  
P T  
Pr ot hr o m bi n ti me  
P T T  
P artial t hr o m b o plasti n  ti me 
P V  
P ul m o nar y vei n  
P VI  
P ul m o nar y vei n is olati o n  
P V S  
P ul m o nar y vei n ste n osis  
S A D E  
Seri o us a d verse d e vice effect  
S A E  
Seri o us a d verse e ve nt  
T E E  
Tra nses o p ha g eal e c h ocar di o gra p h y  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 1 9  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
TI A  
Tra nsie nt isc he mic attac k  
T T E  
Tra nst h oracic ec h ocar di o gra p h y  
T T M  
Tra nstele p h o nic m o nit or  
U A D E  
U na ntici pate d a d v erse d e vice effect  
U S A D E  U na ntici pate d seri o us a d verse de vi ce effect  
 
 
 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2 0  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
1. I ntr o d ucti o n 
1. 1  
B ac k gr o u n d a n d R ati o n ale  
Atrial fi brillati o n ( A F) is t he m ost c o m m o n s ustai ne d car di ac arr h yt h mia, affecti n g 
a p pr o xi matel y 2. 2 milli o n pe o ple i n t he U nite d States a n d 4. 5 milli o n i n t he E ur o pea n 
U ni o n. 1 , 2.  T he i nci de n ce i ncreas es wit h a d va n ci n g a ge, affecti n g 6 % of t he p o p ulati o n 
o ver a ge 6 0  a n d 1 0 % of t he p o p ulati o n o ver a g e 8 0 3 , 4.  A ge-a dj uste d p o p ulati o n 
tre n di n g pr ojects 1 6 milli o n pe o ple i n t he U nite d States will ha ve A F b y 2 0 5 05.  Atrial 
fi brillati o n re mai ns a si g nifica nt ca us e of m or bi dit y a n d m ortalit y i n i n d ustrialize d 
s ocieties.  T he a n n u al ris k of A F relate d str o ke is 5 % per year a n d o ne of e ver y si x 
str o kes dia g n ose d occ urs i n t he prese nce of A F. 6 T heref ore, patie nts wit h A F re q uir e 
l o n g-ter m a ntic oa g ulati o n t o pre ve nt e m b olic e v e nts.  Fail ure t o ma na g e A F ma y als o 
lea d t o a nat o mic a n d electrical re m o deli n g of t he l eft atri u m, tac h ycar dia-i n d uce d 
car di o m y o pat h y, a n d re d uce d left ve ntric ular f u ncti o n ( heart fail ure).  A F re mai ns a n 
e xtre mel y c ostl y p u blic h ealt h b ur de n, wit h a n n u al per patie nt c ost of care a p pr oac hi n g 
€ 3 0 0 0 (a p pr o xi matel y U. S.  $ 3 2 0 0). 7  
T he Heart R h yt h m S ociet y ( H R S) 2 0 1 7 C o nse ns us State me nt o n Cat heter a n d S ur gical 
A blati o n of Atrial Fi brill ati o n 8 defi nes se veral differe nt sta ges of atrial fi brillati o n. 
Par o x ys mal A F ( P A F) is defi ne d as A F t hat ter mi n ates s p o nta ne o usl y or wit h 
i nter ve nti o n wit hi n 7 da ys of o nset.   
T his trial e xte n ds t he i n vesti gati o n of P A F treat m e nt b y F A R A P U L S E p ulse d fiel d 
a blati o n i n t w o i m p orta nt wa ys. Firstl y,  t he de vices utilize d ha ve bee n re d esi g ne d t o be 
m ore acce pta ble i n a ntici pate d c o m mercial use. Sec o n dl y t he pr ot oc ol has b ee n refi ne d 
t o m ore cl osel y a p pr o xi mate t he data gat h eri n g a n d st u d y pr oce d ures t hat will be 
nece ssar y f or t he u pc o mi n g ra n d o mize d pi v otal tri al.  
1. 2  
Irre versi ble Electr o p or ati o n (I R E)  
Al -Sa kere 2 0 0 7 9 descri b e d irre versi ble electr o p orati o n as a n o n-t her mal tiss ue a blati o n 
tec h ni q ue i n w hic h i nte nse s h ort d urati o n electrical fiel ds are us e d t o per m a ne ntl y o pe n 
p ores i n cell me m bra n es, t h us pr o d uci n g n o n -t her mal tiss ue a blati o n.  T heir st u d y, 
usi n g a m o use m o del, s h o we d c o m plete re gressi o n i n 9 2 % of treate d t u m ors .  I R E 
a blati o n has a tiss ue s pecific mec ha nis m of a bl ati o n .  T he tiss ue i nj ur y fr o m I R E 
a blati o n occ urs at t he cell ular le vel wit h l oss of h o me ostasis lea di n g t o necr osis or 
a p o pt osis .1 0  1 1  1 2  1 3 I R E a blati o n t y picall y s pares t he e xtracell ular matri x, w hic h 
facilitates ra pi d w o u n d h eali n g.1 4 , 1 5 , 1 6 , 1 7 , 1 8 
T h o ms o n 2 0 1 1 1 9 re p orte d a case -seri es st u d y ( N = 3 8) assessi n g t he safet y of I R E f or 
treati n g li ver, ki d ne y or l u n g ca ncers i n h u ma ns.  T he first f o ur p atie nts s h o we d si g ns 
of tra nsie nt ve ntric ul ar arr h yt h mia, s o s u bse q ue nt patie nts were all treate d usi n g 
electr ocar di o gra m (E C G )-s y nchr o nize d deli ver of electr o p orati o n p ulses .  T here were 
t w o f urt her arr h yt h mias, a n d t w o cases of i na d verte nt da ma ge t o nei g h b ori n g or ga ns.  
6 8 % of t u m ors were c o m pletel y a blate d .  T he a ut h ors c o ncl u de d  t hat I R E is safe f or 
cli nical use, pr o vi de d E C G -s y nc hr o nize d deli ver y is use d.   
A researc h gr o u p le d b y F H M Witt ka m pf i n Utrec ht has bee n i n vesti gati n g t he 
p ote ntial effecti ve ness a n d safet y of e pi car di al electr o p orati o n i n A F a blati o n 
pr oce d ures usi n g p orci ne m o dels .  Witt ka m pf 2 0 1 1
2 0 ( N = 1 0) us e d a cir c ular a blati o n 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2 1  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
cat heter a n d s h o we d t h at P VI was ac hi e ve d i n all a ni mals, wit h n o si g n of ste n osis at 3 -
wee k f oll o w u p .  V a n Dri el 2 0 1 4 2 1 ( N = 6) c o nfir me d t his res ult o ut t o 3-m o nt h f oll o w 
u p .  Ne ve n 2 0 1 4 2 2 ( N = 5) s h o we d t hat electr o p orati o n lesi o n de pt h de pe n de d  o n t he 
le vel of ele ctrical e n er g y a p plie d, reac hi n g 8 m m at 3 0 0 j o ules.  
Va n Driel 2 0 1 5 ( N = 2 0) s h o we d t hat electr o p orati o n c o ul d create dee p lesi o ns cl ose t o 
t he p hre nic ner ve wit h o ut da ma ge t o t he ner ve.  Ne ve n 2 0 1 4 si milarl y s h o we d t hat 
nei g h b ori n g c or o n ar y art eries were u n da m a ge d b y electr o p orati o n ( N = 5) .  T hese 
a ni mal st u dies s u g gest t hat irre versi ble electr o p orati o n ca n safel y create dee p lesi o ns i n 
heart tiss ue w he n a p plie d e picar diall y  wit h o ut har mi n g a djace nt tiss ues . 
1. 3  
S u m m ar y of F A R A P U L S E Cli nic al St u dies  
1. 3. 1 
E n d oc ar di al A bl ati o n St u dies  –  T he I M P U L S E St u d y  
F A R A P U L S E, I nc . i nitiate d a safet y a n d feasi bilit y st u d y at Na H o m olce H os pital i n 
Pra g ue, Czec h Re p u blic a n d H o pital Car di ol o gi q ue d u Ha ut -L e ve q ue i n Pessac, 
Fra n ce u n der t he “I M P U L S E” Pr ot oc ol, C S 0 1 8 8.  T his st u d y is bei n g c o n d ucte d 
usi n g t he F A R A P U L S E E n d ocar dial A bl ati o n S yste m , f u ncti o nall y t he sa me s yste m 
w hic h will be use d i n t he s u bject i n vesti gati o n  wit h t he a d diti o n of t he F A R A F L E X 
cat heter ( pleas e refer t o s ecti o n 1. 5 f or m ore i nf or mati o n) .  F ort y ( 4 0)  p atie nts were  
e nr olle d bet wee n Ja n u ar y a n d Dece m ber  of 2 0 1 8 .  T hirt y ( 3 0) patie nts were e nr olle d 
i n Pra g ue a n d te n ( 1 0) were e nr olle d i n B or dea u x.  All patie nts were disc h ar ge d i n 
g o o d c o n diti o n.  O ne patie nt was treate d f or t a m p o na de at t he c o ncl usi o n of t he I n d e x 
Pr oce d ure a n d t he e v e nt was res ol ve d.  T hree patie nts were  re-h os pitaliz e d  f or atrial 
arr h yt h mia a n d all of t hese e ve nts were res ol ve d.  O ne pat ie nt e x p erie nce d a 
pr ol o n ge d I n de x h os pitalizati o n d ue t o a n art eri o v e n o us gr oi n fist ula w hic h was 
res ol ve d.  At t he c o n cl usi o n of t he I n de x Pr oce d ure, all ( 1 0 0 %) p ul m o nar y vei ns 
( P Vs) were is olate d usi n g t he F A R A P U L S E E n d ocar dial A blati o n S yste m .  T hirt y -
fi ve ( 3 5) patie nts h a ve ret ur ne d f or t he pr ot oc ol -d efi ne d 3 -m o nt h re m a p pi n g 
pr oce d ure t o assess d ura ble  P V is olati o n.  A m o n g t hese patie nts, 7 0 % of P Vs 
re mai ne d is olate d at t he 3-m o nt h re ma p pi n g pr oce d ure.  All P Vs i n f o urtee n ( 1 4) 
patie nts re mai ne d is olat e d.  T hese res ults s u p p ort t he safet y a n d perf or ma n ce of t he 
s yste m. 
1. 3. 2  
E n d oc ar di al A bl ati o n St u dies –  T he P E F C A T  St u d y  
F A R A P U L S E, I nc . h as als o i nitiate d a safet y a n d feasi bilit y st u d y at Na H o m olce 
H os pital i n Pra g ue, Czec h Re p u blic  a n d H o pital Car di ol o gi q ue d u Ha ut -L e ve q ue i n 
Pessac, Fra nce  u n der t h e “ P E F C A T ” Pr ot oc ol, C S 0 2 6 7. T his st u d y is bei n g 
c o n d ucte d usi n g t he F A R A P U L S E E n d ocar dial A blati o n S yste m , f u ncti o nall y t he 
sa me s yste m w hic h will be use d i n t he s u bject i n v esti gati o n wit h t he a d diti o n of t he 
F A R A F L E X cat heter ( please refer t o secti o n 1. 5 f or m ore i nf or mati o n) .  Si xt y ( 6 0)  
patie nts ha ve bee n e nr oll e d bet wee n Oct o ber 2 0 1 8  a n d J u ne 2 0 1 9 .  Fift y ( 5 0) patie nts 
were e nr olle d i n Pra g ue a n d te n ( 1 0) were e nr olle d i n B or dea u x.   All patie nts w ere 
disc har ge d i n g o o d c o n diti o n.  O ne patie nt was treate d f or a n air e m b olis m d uri n g t he 
I n d e x Pr oce d ure a n d t he e ve nt was res ol ve d.  T hree patie nts were re-h os pitaliz e d f or 
atrial arr h yt h mia  a n d all of t hese e v e nts were res ol ve d.  O ne patie nt w as h os pita lize d 
f or bac k p ai n a n d t he e ve nt was res ol ve d.  O n e patie nt e x perie n ce d a pr ol o n ge d I n de x 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2 2  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
h os pitalizati o n d ue t o a n arteri o ve n o us gr oi n fist ula w hic h was res ol ve d.  At t he 
c o ncl usi o n of t he I n de x Pr oce d ure, all p ul m o nar y vei ns ( P Vs)  i n all patie nts were 
is olate d usi n g t he F A R A P U L S E E n d ocar dial A bl ati o n S yste m .  F ort y -ni ne ( 4 9) 
patie nts ha ve ret ur ne d f or t he pr ot oc ol -defi ne d 7 5 -da y re m a p pi n g pr oce d ure t o assess 
d ura ble P V is olati o n.  A m o n g t hese patie nts, 9 6 % of P Vs re mai ne d is olat e d at t he 3 -
m o nt h re ma p pi n g pr oce d ure  All P Vs i n t hirt y -ni ne ( 3 9) patie nts u n der g oi n g 
reassess me nt re mai ne d is olate d.  T hese res ults s u p p ort t he safet y a n d perf or ma nce of 
t he s yste m. 
1. 3. 3  
E n d oc ar di al A bl ati o n St u dies –  T he P E F C A T  II St u d y 
F A R A P U L S E, I nc. h as i nitiate d re g ulat or y s u b miss i o ns f or t he P E F C A T II e x pa n de d 
safet y a n d feasi bilit y st u d y of t he F A R A P U L S E E n d ocar dial M ulti A blati o n S yste m.  
T his st u d y will i n vesti gate P VI a n d C TI a bl ati o n usi n g t he F A R A W A V E  a n d 
F A R A F L E X  cat heters.  It is e x pecte d t o c o m me nce i n Oct o ber 2 0 1 9.  
1. 4  
R ati o n ale f or C o n d ucti n g T his Fe asi bilit y St u d y  
Cat heter a blati o n f or P A F  wit h a variet y of e n er g y s o urces a n d cat heter c o nfi g urati o ns 
has bee n de m o nstr ate d t o be a safe a n d effecti ve pr oce d ure. Pri or iterati o ns  of t he   
F A R A P U L S E A blati o n S yste m Pl us  ha ve  u n der g o ne precli nical a n d cli nical testi n g t o 
de m o nstrate t hat t he y ca n is olate p ul m o nar y vei ns q uic kl y a n d wit h mi ni mal 
c o m plicati o ns, usi n g a sta n dar d cat heter -bas e d e n d ocar dial pr o ce d ure.  O n g oi n g cli nical 
f oll o w-u p de m o nstrates d ura ble lesi o ns at 7 5 -d a y  re ma p pi n g pr oce d ures a n d free d o m 
fr o m rec urre nt P A F great er t ha n 8 5 %.  F urt her, t he F A R A P U L S E A blati o n S yste m 
Pl us  has u n der g o ne precli nical testi n g i n re prese nt ati ve m o dels t o de m o nstrate t hat it 
ca n is olate p ul m o nar y v ei ns a n d create ot her car di ac lesi o ns q uic kl y, d ura bl y, a n d wit h 
mi ni mal c o m plicati o ns, usi n g a sta n dar d ca t heter-base d e n d ocar dial pr o ce d ure.  
T his st u d y c o nstit utes t he fi nal pil ot st u d y utilizi n g b ot h c o m merciall y desi g ne d de vices 
as well as a trial d esi g n t hat rese m bles t he i nte n d e d pi v otal st u dies f or mar ket a p pr o val. 
C o nfir mati o n of t he fi nal desi g n a n d t h e cli nical trial str uct ure is t he a p pr o priate ne xt 
ste p bef ore st arti n g a lar g e, gl o bal, m ultice nter ra n d o mize d pi v otal st u d y of 
F A R A P U L S E  P F A tec h n ol o g y c o m pare d wit h e xisti n g ra di ofre q ue n c y a n d 
cr y oa blati o n tec h n ol o gies.  
 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2 3  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
2.  I n vesti g ati o n al De vices 
2. 1  
N a me s o f I n vesti g ati o n al De vices 
T he F A R A P U L S E A blati o n S yste m Pl us  is c o m prise d of t he f oll o wi n g de vices: 
•  F A R A W A V E E n d ocar di al A blati o n Cat heter  
•  F A R A F L E X E n d ocar dial A blati o n Cat heter  
•  F A R A S T A R Ge nerat or  
•  F A R A D RI V E Steera ble  S heat h  
•  F A R A D RI V E Deflecta bl e S heat h  
2. 2  
I nte n de d Use 
T he F A R A P U L S E A blati o n S yste m Pl us  is i n dicate d f or t he treat me nt of dr u g 
refract or y, rec urre nt, s y m pt o matic par o x ys mal atri al fi brillati o n.   
T he F A R A F L E X E n d o car dial A blati o n Cat heter is use d as a n a dj u n cti ve de vice i n t he 
e n d ocar di al treat me nt of atrial fi brillati o n wit h t he f oll o wi n g inte n de d uses:  
•  Ga p a blati o n t o c o m plete electrical is olati o n of t he p ul m o nar y vei ns,  
•  F ocal a blati o n of car diac arr h yt h mias, a n d  
•  Creati o n of a blati o n li ne bet wee n t he i nferi or v e na ca va a n d t he tric us pi d val ve.  
2. 3  
Cl assific ati o n  
T he  F A R A W A V E E n d o car dial A bla ti o n Cat heter a n d F A R A F L E X E n d o car dial 
A blati o n Cat heter  are classifie d as Class III me dical de vice s.  Per  M D D 9 3/ 4 2/ E E C 
A n ne x I X R ule 6 a p plies t o t he a blati o n cat heter s, w hic h defi nes t he cat het ers as  
s ur gicall y i n vasi ve de vic es i nte n de d f or tr a nsie nt use ( < 6 0 mi n) t hat s pe cificall y 
c o ntr ols, dia g n oses, m o nit ors or c orrects a d efect of t he heart or of t he ce ntr al 
circ ulat or y s yste m t hr o u g h direct c o ntact wit h t hese parts of t he b o d y.  
T he F A R A S T A R Ge nerat or  is classifie d as a Clas s II b me dical de vi ce.   Per M D D 
9 3/ 4 2/ E E C A n ne x I X R ule 9 a p plies t o t he Ge nerat or , w hic h defi nes it as a n acti ve 
t hera pe utic d e vice t hat is i nte n de d t o a d mi nister or e xc ha n g e e ner g y t o a n d fr o m t he 
h u ma n b o d y i n a p ote ntiall y hazar d o us wa y, ta ki n g acc o u nt  of t he n at ure, t he de nsit y 
a n d t he site of a p plicati o n of t he e ner g y .   
T he F A R A D RI V E Steera ble  S heat h a n d F A R A D RI V E Deflecta ble S heat h are  
classifie d as Class III me dical de vice s.  Per M D D 9 3/ 4 2/ E E C A n ne x I X R ule 6 a p plies 
t o t he Steera ble  a n d Defl ecta bl e S heat h S yste m s, w hic h defi ne t he m as s ur gicall y 
i n vasi ve de vices i nte n d e d f or tra nsie nt use ( < 6 0 mi n) t hat s pecificall y c o ntr ol, 
dia g n ose, m o nit or or c orrect a defect of t he heart or of t he ce ntral circ ulat or y s yste m 
t hr o u g h direct c o ntact wit h t hese parts of t he b o d y. 
2. 4  
F A R A P U L S E A bl ati o n S yste m Pl us  
T he F A R A P U L S E A blati o n S yste m Pl us  use d i n t he pr o p ose d  cli nical i n vesti gati o n 
c o nsists of t he F A R A W A V E  E n d ocar dial A blati o n Cat heter, t he F A R A F L E X 
E n d ocar dial A bl ati o n Cat heter, t he F A R A S T A R Ge nerat or , F A R A D RI V E Deflect a ble 
S heat h, a n d t he F A R A D RI V E  Steera ble  S heat h . T hese c o m p o ne nts, s u b -c o m p o ne nts 
a n d m o del n u m bers are liste d i n T a ble 1 . 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2 4  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
 
T a ble 1 . F A R A P U L S E  E n d oc ar di al A bl ati o n S yste m  –  C o m p o ne nts  
 
C o m p o ne nt  
S u bc o m p o ne nts  
M o del N u m bers  
F A R A W A V E E n d ocar di al 
A blati o n Cat heter  
 
 
1.  A blati o n Cat heter ( 3 1 m m or 3 5 
m m f ull y de pl o ye d dia meter)  
 
2.  E xte nsi o n Ca ble  
 
4 1 C 6 0 1 ( 3 1 m m) a n d 
4 1 C 6 0 2  ( 3 5 m m) 
 
4 1 C 6 0 4  
F A R A F L E X E n d ocar dial 
A blati o n Cat heter  
(a dj u ncti ve de vic e) 
1.  A blati o n Cat heter ( 1 7 m m f ull y 
de pl o ye d  dia meter)  
2.  E xt e nsi o n C a bl e  
 
4 1 C 6 0 3  
 
4 1 C 6 0 4  
F A R A S T A R Ge nerat or  
 
 
 
 
1.  P ulse d Fiel d A blati o n  Ge nerat or  
2.  F A R A S T A R Re m ote T o uc h 
Scree n  
3.  F A R A S T A R F A R A S TI M B o x  
4.  F A R A S T A R F A R A S TI M Ca ble  
5.  F A R A S T A R E G M Ca bl e  
6.  F A R A S T A R Access ories Ca ble 
Set  
7.  Rec or di n g  S witc h B o x  
 
6 1 C 6 0 1  
6 1 C 6 0 2  
6 1 C 6 0 3  
6 1 C 6 0 4  
6 1 C 6 0 5  
6 1 C 6 0 6  
 
 
6 1 C 6 0 7  
F A R A D RI V E Steera ble 
S heat h  
 
F A R A D RI V E Deflecta bl e 
S heat h   
 
 
1.  S heat h  a n d Dilat or  
 
1.  S heat h a n d Dilat or  
2 1 C 6 0 1  
 
2 0 T 4 0 1  
 
D uri n g  t he i n vesti gati o n certai n C E Mar ke d me di cal de vices ma y be use d i n 
c o nj u ncti o n wit h t he F A R A P U L S E A blati o n S yste m Pl us . T hese  are liste d i n T a ble 2 . 
 
T a ble 2 . C E M ar ke d De vic es Utilize d i n C o nj u ncti o n wit h F A R A P U L S E S yste m  
 
C E M ar ke d De vices T h at M a y be Use d i n C o nj u ncti o n wit h  
F A R A P U L S E A bl ati o n S yste m Pl us  
St. J u de B R K 9 8c m Tra nsse ptal Nee dle  
 
A sc he matic of t h e  F A R A P U L S E A blati o n S yste m Pl us  is de picte d i n Fi g ure 1 . 
 
 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2 5  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
 
 
Fi g ure 1 . 
F A R A P U L S E A bl ati o n S yste m Pl us  C o m p o ne nts  
 
2. 4. 1 
F A R A W A V E  E n d oc ar di al A bl ati o n C at heter  
T he F A R A W A V E  E n d o car dial A blati o n Cat heter c o nsists of t w o ( 2) c o m p o ne nts: 
A blati o n Cat heter a n d E xte nsi o n Ca ble, w hic h are use d t o get her.  B ot h c o m p o ne nts 
are sterile a n d si n gle use o nl y.  
T he a blati o n cat h eter is offere d i n t w o differe nt sizes: 3 1 m m ( R E F 4 1 C 6 0 1 ) a n d 
3 5 m m ( R E F 4 1 C 6 0 2 ) de pl o ye d dia meters, t o acc o m m o date var yi n g p ul m o nar y vei n 
a nat o m y. Selecti o n of eit her cat h eter will be at t he i n vesti gat or’s discreti o n.  
T he A blati o n Cat heter is a m ulti -electr o de cat heter t hat c o n nects electricall y t o t he 
E n d ocar dial G e nerat or  (Fi g ure 2 ).  It c o nsists of a distal secti o n wit h electr o des 
arra n g e d o n s pli nes , a s h aft secti o n, a n d a pr o xi mal ha n dle wit h a ma n u all y o perate d 
de pl o y me nt c o ntr ol .  T he fi ve s pli nes de pl o y i nt o a bas ket -s ha p e d c o nfi g urati o n or 
fl o wer-s h a pe d c o nfi g urati o n wit h fi ve petals (Fi g ure 3 ).   
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2 6  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
 
Fi g ure 2 . 
F A R A W A V E E n d oc ar di al A bl ati o n C at heter  
 
 
Fi g ure 3.  U n de pl o ye d (t o p) a n d F ull y De pl o ye d “ Fl o wer ” ( mi d dle left a n d ri g ht) 
vs. P arti all y De pl o ye d “ B as ket ” ( b ott o m left) C o nfi g ur ati o ns of t he 
F A R A W A V E E n d oc ar di al A bl ati o n C at heter Dist al E n d  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2 7  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
Eac h s pli ne has a si n gle electr o de t h at is se parat el y wire d t o facilitate c o n n ecti o n t o a 
ma p pi n g or rec or di n g s yste m  via a ca ble s u p plie d wit h t he s yste m.  T he ha n dle 
i ncl u des a fl us h p ort f or sali ne i nf usi o n, a de pl o y m e nt c o ntr ol k n o b wit h a g ui de wire 
l u me n h u b t hat ca n be c o n necte d t o a h e m ostasis val ve, a n d a s h ort ca ble t h at 
ter mi nates i n a si n gle c o n nect or f or attac h me nt t o t he e xte nsi o n ca bl e.  The ot her e n d 
of t he e xte nsi o n ca ble  att ac hes t o t he fr o nt pa nel of t he F A R A S T A R E n d ocar dial 
Ge nerat o r. T he e xte nsi o n ca ble is pac k a ge d sterile a n d is si n gle -use o nl y. T he P ulse d 
Fiel d A blati o n  e ner g y is deli vere d via t he F A R A S T A R E n d ocar dial  Ge nerat or o ver 
t he set of a blati o n cat heter electr o d es.   
A d diti o nal details are pr o vi de d i n t he I F U L B L 0 7 7 4  f or t he s pecific use a n d 
pr oce d ural ste ps of t he F A R A W A V E E n d o car dial A blati o n Cat heter.  
2. 4. 2  F A R A F L E X E n d oc ar di al A bl ati o n C at heter  
T he F A R A F L E X E n d o car dial A blati o n Cat heter is a m ulti -electr o de u ni directi o nal, 
deflecta bl e perc uta ne o us cat heter t h a t c o n nects t o t he F A R A S T A R E n d ocar dial 
Ge nerat or a n d is desi g ne d t o deli ver P F A  e n er g y fr o m t he E n d ocar di al Ge n erat or f or 
car diac tiss ue a blati o n.  T he F A R A F L E X E n d o car dial A blati o n Cat heter is a n 
a dj u ncti ve cat het er desi g ne d t o create s maller f ocal -t y pe lesi o ns f or t he f oll o wi n g 
i n dicati o ns f or use: 
•  Ga p a blati o n t o c o m plete electric al is olati o n of t he p ul m o nar y vei ns,  
•  F ocal a blati o n of car diac arr h yt h mias, a n d  
•  Creati o n of a blati o n li ne bet wee n t he i nferi or v e na ca va a n d t he tric us pi d val ve.  
 
T he cat het er c o nsists of t he f oll o wi n g maj or secti o ns: 1) distal secti o n wit h electr o des 
arra n g e d o n f o ur ( 4) s pli nes, 2) cat h eter s haft, a n d 3) pr o xi mal ha n dle wit h ma n uall y 
o perate d d eflecti o n a n d d e pl o y me nt c o ntr ols, fl us h p ort, a n d c o n nect or . Fi g ure 4  
de picts a d e pl o ye d F A R A F L E X E n d o car di al A blati o n Cat heter.  
 
 
 
Fi g ure 4 . 
F A R A F L E X E n d oc ar di al A bl ati o n C at heter  
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2 8  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
T he cat heter ca n be de pl o ye d i nt o bas ket -s ha pe d c o nfi g urati o ns t o acc o m m o date 
vari o us a nat o mical l ocati o ns . T he a blati o n cat heter is visi ble u n der fl u or osc o p y d ue t o 
t he prese n ce of mar ker b a n ds at t he distal ti p a n d pr o xi mal e n d of the s pli n es, as well 
as electr o d es o n eac h of f o ur ( 4) s pli nes.  
2. 4. 3  F A R A S T A R  Ge ner at or  
T he F A R A S T A R Ge nerat or  c o nsists of t he f oll o wi n g c o m p o ne nts –  P ulse d Fiel d 
A blati o n  Ge nerat or ( P F A G), Sti m ulat or I nterface B o x ( SI B), SI B t o Ge nerat or ca ble, 
Ge nerat or t o Rec or di n g/ Ma p pi n g S yste m Pi n b o x  ca ble, a n d Rec or di n g  S witc h B o x .  
T he E n d ocar dial Ge n erat or  is desi g ne d t o deli ver P F A  e ner g y t o e n d ocar di al sites i n 
t he heart via t he F A R A W A V E a n d F A R A F L E X E n d ocar dial A bl ati o n Cat heter s 
(refer t o I F U L B L 07 7 4  a n d I F U L B L 0 7 7 6  f or t he s pecific use a n d pr oce d ural ste ps of 
t he E n d ocar di al A blati o n Cat heters, res p ecti vel y; L B L 0 7 7 1  f or t he F A R A D RI V E 
Steera ble  S heat h , L B L 0 1 9 3 f or t he F A R A D RI V E Deflect a ble S heat h, L B L 0 7 8 4  f or 
t he F A R A S T A R Ge n erat or , a n d L B L 0 8 9 2 f or t he Rec or di n g S witc h B o x).   
T he F A R A S T A R E n d ocar dial  Ge n erat or  is a 12 -c ha n nel o ut p ut u nit t hat ge nerates a 
p ulse d v olta ge wa vef or m t hat ca n be d eli vere d t o t he F A R A W A V E or F A R A F L E X 
a blati o n cat heters . T he us er selecta ble v olta ge ra n g e f or t he F A R A W A V E A b lati o n 
Cat heter is 1 8 0 0 V t o 2 0 0 0 V a n d t he ra n ge f or t he F A R A F L E X A blati o n Cat heter is 
1 2 0 0 V t o 1 8 0 0 V . 
T he F A R A S T A R Ge nerat or i ncl u des a t w o c h a n nel Car diac Sti m ulat or t hat ca n be 
c o n necte d t o user s u p plie d paci n g cat h eters t hr o u g h t he SI B. T he F A R A S T A R e ne r g y 
deli ver y is s y nc hr o nize d wit h t he Car diac Sti m ulat or o ut p uts. T he p h ysicia n c o nfir ms 
paci n g ca pt ur e  b y act uati n g a b utt o n o n t he F A R A S T A R E n d ocar dial Ge n erat or  user 
i nterface pri or t o i nitiati n g e ner g y deli ver y . 
Details re gar di n g t he ge n erat or are  pr o v i de d i n t he F A R A S T A R Ge nerat or  User 
Ma n ual L B L 0 7 8 4 . 
2. 4. 4  F A R A D RI V E  D eflect a ble a n d Steer a ble  S he at h s  
T he F A R A W A V E E n d ocar dial A blati o n Cat heter a n d F A R A F L E X E n d o car dial 
A blati o n Cat heter are  use d wit h eit her t he F A R A D RI V E Deflecta ble S heat h or t he 
F A R A D RI V E Steera ble  S heat h .  T he F A R A D RI V E Deflecta ble S heat h is t he s heat h 
use d i n t he I M P U L S E, P E F C A T, P E F C A T II, a n d Pers A F O ne cli nical i n v esti gati o ns 
st u d yi n g t he F A R A P U L S E E n d ocar dial A blati o n S yste m a n d F A R A P U L S E 
E n d ocar dial M ulti A blati o n S yste m.  T he F A R A D RI V E Steera ble S heat h is i de ntical 
i n desi g n t o t he F A R A D RI V E Deflecta ble S heat h, e xce pt f or c os metic c h a n ges. 
T he F A R A D RI V E Deflecta ble  S heat h c o nsists of t w o ( 2) pri mar y c o m p o ne nts: 
Steera ble  S heat h a n d Dilat or , w hic h are use d t o get her.  B ot h c o m p o ne nts are sterile 
a n d si n gle use o nl y . 
T he F A R A D RI V E Deflecta ble  S heat h is c o m prise d of a distal deflecta ble s ecti o n a n d 
a s haft secti o n w hic h c o n nect t o t he ha n dle.  T h e h a n dle i ncl u des a k n o b t o c o ntr ol 
t he deflecti on of t h e distal ti p a n d a fl us h p ort f or i nf usi o n of sali ne or c o ntr ast.  T he 
Dilat or is i nte n de d f or i nserti o n t hr o u g h t he s heat h l u me n a n d i ncl u des a s ha pe d ti p 
f or dilati o n f or vasc ul ar or c ha m ber access (Fi g ure  5 ). 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 2 9  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
 
T he F A R A D RI V E  Steera ble  S heat h c o nsists of t w o ( 2) pri mar y c o m p o ne nts: 
Steera ble  S heat h a n d Dilat or, w hic h are use d t o get her .  B ot h c o m p o ne nts are sterile 
a n d si n gle use o nl y . 
T he F A R A D RI V E Steera ble  S heat h is c o m prise d of a distal deflecta ble secti o n a n d a 
s haft secti o n w hic h c o n n ect t o t he  ha n dle .  T h e ha n dle i ncl u des a k n o b t o c o ntr ol  t he 
deflecti o n  of t he distal ti p  a n d a fl us h p ort f or i nf usi o n of sali ne or c o ntrast .  T he 
Dilat or is i nte n de d f or i nserti o n t hr o u g h t he s heat h l u me n a n d i ncl u des a s ha pe d ti p 
f or dilati o n f or vasc ul ar or c ha m ber access (Fi g ure  5 ). 
  
 
Fi g ure 5 . 
F A R A D RI V E  Steer a bl e  S he at h a n d Dil a t or (e q ui v ale nt t o 
F A R A D RI V E D eflect a ble S he at h)  
 
2. 5  
De vice A cc o u nt a bilit y  
T he F A R A P U L S E A blati o n S yste m Pl us  will be st ore d i n a sec ure l ocati o n a n d access 
will be c o ntr olle d .  Rec or ds will be mai ntai ne d t o d oc u me nt t he p h ysical l o cati o n of 
i n ve nt or y fr o m s hi p me nt a n d re m o val fr o m S p o ns or or C o ntract Ma n ufact ure facilit y 
t hr o u g h use a n d / or ret ur n or dis p osal.  
T he site will be res p o nsi ble f or mai ntai ni n g a  De vice Acc o u nta bilit y L o g pr o vi de d b y 
t he S p o ns or or its desi g nate d re prese ntati ve. A t a mi ni m u m t he f oll o wi n g will be 
rec or de d: Date of recei pt, F A R A P U L S E A blati o n S yste m Pl us  c o m p o ne nts 
i de ntificati o n n u m ber (G e nerat or, A blati o n Cat het er , Deflecta bl e S heat h, a n d Steera ble  
S heat h l ot a n d / or serial n u m ber), e x pir ati o n date, date of use, s u bject u ni q ue 
i de ntificati o n c o de a n d d ate of dis p osal or ret ur n of t he de vice.  
If t here is a pr o d uct D e vice D eficie nc y / Malf u ncti o n or ot her nee d t o r et ur n t he s yste m 
or s yste m c o m p o ne nts t o t he S p o ns or  or C o ntract Ma n ufact ur e , t he S p o ns or or desi g nee 
s h o ul d be c o ntacte d f or s afe pr o d u ct dis p osal a n d/ or ret ur n det ails.  A p pr o priate C R F 
will be c o m plete d i n t he e ve nt of a De vice Defi cie nc y / Malf u ncti o n . 
T he I n vesti gat or is r es p o nsi ble f or e ns uri n g t hat t he i n vesti gati o nal de vices are use d 
o nl y u n der t he I n vesti gat or’s s u per visi o n a n d are o nl y use d acc or di n g t o t his pr ot oc ol 
a n d a n y a p pr o ve d a me n d me nts .  T he I n vesti gat or will  n ot s u p pl y a n i n vesti gati o nal 
de vice t o a n y p ers o n n ot a ut h orize d t o partici pate i n t he st u d y .  T he I n v esti gat or s hall 
d oc u me nt o n  t he Case Re p ort F or ms ( C R Fs) t he l ot n u m bers a n d / or serial n u m bers of 
t he de vices use d d uri n g eac h case. 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3 0  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
2. 6  
Ret ur n of De vi ces  
All u n use d i n vesti gati o nal de vices will be ret ur n e d t o t he S t u d y S p o ns or or desi g nee 
u p o n c o m pleti o n of t he cli nical st u d y .  A n y i n vesti gati o nal de vice t hat d oes n ot meet 
perf or ma n ce s p ecificati o ns will als o be ret ur ne d t o t he S t u d y S p o ns or or desi g nee f or 
a nal ysis  per c o m pa n y pr oce d ures .  T h e I n v esti gat or or his/ her desi g nate d 
re pres e ntati ve is res p o nsi ble f or de vice acc o u nta bilit y a n d dis p ositi o n of all use d a n d 
u n use d de vices .  T h e S t u d y S p o ns or or its desi g nate d re prese ntati ve will c o n d uct 
de vice rec o nciliati o n at t he c o m pleti o n of s u bject e nr oll me nt or at t he c o n cl usi o n of t he 
st u d y. 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3 1  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
3.  St u d y  Desi g n  
3. 1  
St u d y O bjecti ve  
T he o bjecti ve of t his pil ot st u d y is t o c o nfir m t hat e n d ocar di al a blati o n usi n g t he 
F A R A P U L S E A blati o n S yste m Pl us  wit h c o m mercial desi g n de vices is b ot h  safe a n d 
effecti ve f or tr eati n g dr u g-resista nt par o x ys mal atrial fi brillati o n (P A F ).  
3. 2  
St u d y O ver vie w  
T his is a pr os pecti ve, m ulti -ce nter, si n gle ar m safet y a n d effecti ve ness pil ot  st u d y.  
S u bjects will u n der g o perc uta ne o us P F A  a blati o n f or p ul m o nar y vei n is olati o n a n d at 
t he cli nical discreti o n of t he i n vesti gat or recei ve P F A a blati o n of a d diti o nal 
arr h yt h m o ge nic l ocati o ns . S u bjects will be f oll o we d at 7 da ys (tele p h o nic), 3 0 da ys, 9 0  
da ys, 6 m o nt hs a n d 1 2 m o nt hs f or a d verse e v e nts, rec urre nce of arr h yt h mia after a 9 0 -
da y Bla n ki n g Peri o d a n d ot her rele va nt o utc o me meas ures.  
3. 3  
S u bject C o nfi de nti alit y  
E nr olle d s u bjects will be assi g ne d a u ni q ue, pse u d o -a n o n y m o us i de ntifier t hat will be 
use d t o mai ntai n c o nfi de ntialit y of eac h s u bject’s me dical i nf or mati o n.  S u bject na mes 
a n d ot her pr otecte d healt h i nf or mati o n will n ot be ca pt ure d o n t he C R Fs .  I n a d diti o n, 
all patie nt i de ntifiers e xce pt t he u ni q ue pse u d o -a n o n y m o us i de ntifier s h o ul d be 
re dact e d fr o m a n y i ma g es or ot her data s u b mitte d fr o m t he partici pati n g site t o t he 
S p o ns or or t he S p o ns or’s desi g nate d re vi e wers f or a nal ysis.  All i nf or mati o n c o n cer ni n g 
s u bjects or t heir partici p ati o n i n t his st u d y will be c o nsi dere d c o nfi de ntial.  O nl y t he 
a ut h orize d S p o ns or, desi g nate d re prese ntati ve pers o n nel, desi g nate d c o ns ulta nts a n d 
re g ulat or y a g e ncies will ha ve access t o t hese c o nfi de ntial files.   
3. 4  
Writte n  I nf or me d C o nse nt 
All s u bjects m ust pr o vi de writte n I nf or me d C o nse nt usi n g t he E C -a p pr o ve d I C F bef ore 
u n der g oi n g a n y st u d y rel ate d pr oce d ures.   
R o uti ne cli nical e val uati o ns t hat w o ul d be perf or me d as part of t he n or mal cli nical care 
of patie nts ma y be per f or me d pri or t o s uc h c o nse nt a n d use d as part of t he s cree ni n g 
assess me nt.  If t he s u bject is s u bse q ue ntl y c o nse nte d a n d e nr olle d i n t he st u d y, t he 
res ults of s uc h e v al uati o ns ma y be use d as st u d y d ata. 
S u bjects ca n n ot be as k e d t o si g n t he I C F u ntil t he st u d y has bee n f ull y a p pr o ve d b y t he 
i nstit uti o n’s E C a n d b y t he C A , if a p plica ble, a n d t he S p o ns or or t heir C R O 
re pres e ntati ve has r ecei ve d a n d re vi e we d t he E C-a p pr o ve d I C F.  S u bjects w h o meet t he 
ge neral e ntr y criteria will be as ke d t o si g n a n I C F  as a p pr ove d b y t h e rele va nt 
re g ulat or y a ut h orities b ef ore a n y st u d y-s pecific tests or pr oce d ures are perf or me d.   
T he I n vesti gat or or a desi g nate d me m ber of his  / her staff s h o ul d a p pr oac h t he s u bject 
t o o btai n writte n i nf or me d c o nse nt.  As far as p ossi ble, n o n-tec h nical la n g u a ge s hall be 
use d t hat is u n dersta n da ble t o t he s u bject.  T he bac k gr o u n d of t he pr o p ose d st u d y a n d 
t he be nefits a n d ris ks of t he pr oce d ures a n d st u d y s h o ul d be e x plai ne d.  T h e s u bject 
s h o ul d be pr o vi de d wit h a m ple ti me t o rea d t he I C F a n d discuss it wit h t heir fa mil y a n d 
p h ysicia n.  T he s u bject s hall be i nf or me d t hat his  / her partici pati o n i n t he cli nical 
i n vesti gati o n is c o nfi de ntial.  T he I C F m ust be rea d a n d u n derst o o d b y t he s u bject a n d 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3 2  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
t he s u bject’s q uesti o ns a ns were d.  T h e I C F m ust be si g ne d a n d date d b y b ot h t he 
s u bject a n d I n vesti gat or c o n d ucti n g i nf or me d c o nse nt pri or t o s u bject e nr oll me nt a n d 
bef ore t h e s u bject u n der g oes a n y st u d y -rel ate d pr o ce d ures.  All s u bjects are t o recei ve 
c o pies of t heir si g ne d a n d date d I C F.  A c o p y of t he a p pr o ve d I C F al o n g wit h a c o p y of 
eac h p atie nt’s si g ne d I C F will be mai ntai ne d b y t he I n vesti gat or i n a d esi g nate d cli nical 
st u d y a d mi nistrati ve file.  S u bjects ma y n ot be c o nse nte d after recei vi n g a n y 
me dicati o n t hat mi g ht alter t heir a bilit y t o c o m pre he n d t he c o nse nt f or m (e. g.  
se dati ves, narc otics, etc.).  St u dy pers o n nel s h o ul d e x plai n t hat e ve n if a s u bject a grees 
t o partici pate i n t he st u d y a n d si g ns t he I C F, t he s u bject ma y n ot be eli gi ble t o 
partici pate if he  / s h e fails t o meet t he scree ni n g criteria. 
Writte n i nf or me d c o ns e nt m ust be o btai ne d pri or t o perf or mi n g a n y pr ot oc ol dri ve n 
tests or a n y pr oce d ures t h at are n ot sta n dar d of care f or a p erc ut a ne o us a bl ati o n 
pr oce d ure t hat t he s u bject is sc he d ule d t o u n der g o.  
O nce writte n c o nse nt has bee n o btai ne d, t he s u bject will be e ntere d o n a Scree ni n g L o g, 
w hic h w ill be mai ntai ne d at eac h site.  All s u bjects w h o pr o vi de writte n i nf or me d 
c o nse nt will be e ntere d o n t he scree ni n g l o g re gar dless of w het her or n ot t he y are 
e nr olle d i n t he st u d y.  
 
3. 5  
St u d y E ntr y Criteri a  
3. 5. 1 
I ncl usi o n Criteri a 
St u d y s u bjects are re q uir e d t o mee t all t he f oll o wi n g i ncl usi o n criteria t o partici pate i n 
t his st u d y: 
 
1.  Patie nts wit h d oc u me nte d dr u g resista nt s y m pt o matic P A F meeti n g all t hree of t he 
f oll o wi n g criteria: 
a. C o nfir me d A F: D o c u me ntati o n ma y  i ncl u de a rec or di n g s uc h as E C G, 
tra nstele p h o nic m o nit or ( T T M), H olter m o nit or, i m pla nte d de vices, or 
tele metr y stri p, rec or de d wit hi n o ne year pri or t o e nr oll me nt a n d s h o wi n g at 
least 3 0 sec o n ds of A F. 
b.  Fre q u e nt A F, d efi ne d as ≥ 2 e pis o des wit hi n 6 m o nt hs  of e nr oll me nt.  
c. Faile d atri al fi brillati o n dr u g ( A A D ) treat me nt, mea ni n g t hera pe utic fail ure of 
at least o ne A A D  (class I –  I V) f or effi cac y a n d / or i nt olera nce. 
2.  Patie nts w h o are ≥ 1 8 a n d ≤ 7 5 years of a ge o n t h e da y of e nr oll me nt.  
3.  Patie nt partici pati o n re q uire me nts:  
a. Li ves l ocall y.  
b.  Is willi n g a n d ca pa ble of pr o vi di n g I nf or me d C o ns e nt t o u n der g o st u d y 
pr oce d ures.  
c. Is willi n g t o partici pate i n all e xa mi nati o ns a n d f oll o w-u p visits a n d tests ass ociate d 
wit h t his cli nical st u d y . 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3 3  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
3. 5. 2  E xcl usi o n Criteri a  
S u bjects will  be e xcl u de d fr o m partici pati n g i n t his st u d y if t he y meet a n y o ne of t he 
f oll o wi n g e xcl usi o n criteria: 
 
1.  Atrial fi brillati o n t hat is a n y of t he f oll o wi n g:  
a. Persiste nt ( b y dia g n osis or c o nti n u o us d urati o n > 7 da ys)  
b.  Sec o n dar y t o electr ol yte i m b ala nce, t h yr oi d  diseas e, alc o h ol  or ot her 
re versi ble / n o n-car di ac ca uses  
c. Re q uires ≥ 4 car di o v ersi o ns i n t he prece di n g 1 2 m o nt hs  
2.  Left atrial a nt er o p osteri or dia meter ≥ 5. 0 c m as d o c u me nte d b y tra nst h oraci c 
ec h ocar di o gra p h y ( T T E) or c o m p ute d t o m o gra p h y ( C T) 
3.  At a n y ti me, o ne or m ore  of t he f oll o wi n g car di ac pr oce d ures, i m pla nts or 
c o n diti o ns:  
a. Cli nicall y si g nifica nt arr h yt h mias ot her t ha n A F , A F L or A T 
b.  A n y pre vi o us e n d ocar dial or e picar di al a blati o n or s ur ger y f or A F  
c. He m o d y na micall y si g nifica nt val v ular disease  
d.  A n y pr ost hetic  heart val v e  
e. Heart fail ure –  a n y of t he f oll o wi n g:  
i. N Y H A Class III or I V C H F  
ii. L V E F < 4 0 %  
iii. Heart fail ure h os pitalizati o n  
f. Atrial or ve ntric ular se pt al defect cl os ure  
g.  Atrial m y x o ma  
h.  Left atrial t hr o m b us  
i. Left atrial a p p e n da g e de vice or occl usi o n  
j. Pace ma ker, i m pla nta ble car di o verter defi brillat or or car di ac 
res y nc hr o nizati o n t hera p y de vices 
k.  Si g nifica nt or s y m pt o matic h y p ote nsi o n  
l. Bra d ycar di a or c hr o n otr o pic i nc o m pete nce  
m.  Hist or y of pericar ditis  
n.  Hist or y of r he u matic fe v er 
o.  Hist or y of c o n ge nital heart disease wit h a n y resi d ual a nat o mic or 
c o n d ucti o n a b n or malit y  
p.  A n y p ul m o nar y vei n a b n or malit y, ste n osis or ste nti n g  
4.  A n y of t he f oll o wi n g car di o vasc ular pr oce d ures, i m pla nts or c o n diti o ns wit hi n t he 
s pecifie d i nter val relate d t o t he date of e nr oll me nt:  
a. Wit hi n t he 3 m o nt hs prece di n g e nr oll me nt:  
i. 
M y ocar dial i nfarcti o n  
ii. 
U nsta ble a n gi na  
iii. 
Perc uta ne o us c or o nar y i nter ve nti o n  
i v. 
Treat me nt wit h a mi o dar o ne  
d.  Wit hi n t he 6 m o nt hs prece di n g e nr oll me nt:  
i. 
Heart s ur g er y  
ii. 
Str o ke or TI A  
iii. 
A n y t hr o m b oe m b olic e ve nt  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3 4  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
i v. 
Car oti d ste nti n g or e n darterect o m y  
v.  
Pericar ditis or peri car di al eff usi o n  
e. Wit hi n t he 1 2 m o nt hs f oll o wi n g e nr oll me nt:  
i. A n y li keli h o o d of car diac s ur ger y or tra ns pla nt  
5.  Hist or y of bl o o d cl otti n g or blee di n g a b n or m alities  
6.  C o ntrai n dicati o n t o, or u n willi n g ness t o use, s yste mic a ntic oa g ulati o n  
7.  C o ntrai n dicati o ns t o  b ot h  C T a n d M RI  
8.  Se nsiti vit y t o c o ntrast me dia n ot c o ntr olle d b y pre me dicati o n  
9.  W o me n of c hil d beari n g p ote ntial w h o are pre g na nt, lactati n g , n ot usi n g birt h 
c o ntr ol o r pla n ni n g t o bec o me pre g n a nt d uri n g t he a ntici pate d st u d y peri o d 
1 0.  Me dical c o n diti o ns t hat w o ul d pre ve nt partici pati o n i n t he st u d y, i nterfere wit h 
assess me nt or t hera p y, si g nifica ntl y raise t he ris k of st u d y partici pati o n, or 
c o nf o u n d data or its i nter pret ati o n, i ncl u di n g b ut n ot li mite d t o:  
a. B o d y mass i n de x ( B MI) > 4 0 
b.  S oli d or ga n or he mat ol o gic tra ns pla nt, or c urre ntl y bei n g e val uate d f or a n 
or ga n tra ns pla nt  
c. Se vere l u n g diseas e, p ul m o nar y h y perte nsi o n, or a n y l u n g disease 
i n v ol vi n g a b n or mal bl o o d gases or si g nifica nt d ys p nea 
d.  Re nal i ns ufficie nc y wit h a n esti mate d creati ni ne cl eara n ce < 3 0 
m L/ mi n/ 1. 7 3 m 2 , or a n y hist or y of re nal dial ysis or re nal tra ns pla nt  
e. Acti ve mali g na nc y or hist or y of treate d ca n cer wit hi n 2 4 m o nt hs of 
e nr oll me nt  
f. Cli nicall y si g nifica nt g astr oi ntesti nal pr o ble ms i n v ol vi n g t he es o p ha g us, 
st o mac h a n d/ or u ntreate d aci d refl u x 
g.  Cli nicall y si g nifica nt i nfecti o n  
h.  Pre dicte d life e x p ecta nc y less t ha n o ne year  
1 1.  Cli nicall y si g nifica nt ps yc h ol o gical c o n diti o n t hat i n t he i n vesti gat or’s o pi ni o n 
w o ul d pr o hi bit t he s u bject's a bilit y t o meet t he pr ot oc ol re q uire m e nts.  
1 2.  C urre nt or a ntici pat e d e nr oll me nt i n a n y ot her cli nical st u d y  
 
3. 6  
E nr oll me nt  
S u bjects t hat meet all t he eli gi bilit y criteria a n d are dee me d s uita ble b y t h e i n vesti gat or 
will be i n vite d t o partici pate i n t he st u d y.   
S u bjects will be c o nsi dere d e nr olle d at t he ti me of si g ni n g t he I C F. 
Eac h s u bject will be assi g ne d a u ni q ue st u d y i de ntificati o n c o de t o pr otect eac h 
s u bject’s c o nfi de ntial h ealt h i nf or mati o n.  T he u ni q ue st u d y i de ntificati o n c o de will n ot 
i ncl u de date of birt h or s u bject’s first a n d last i nitials a n d will be use d t o li n k st u d y data 
a n d ot her st u d y i nf or mati o n t o t he s u bject i n lie u of t he s u bject na me.  T h e S u bject 
Na me L o g will be use d t o li n k t he u ni q ue st u d y i de ntit y c o de t o t he s u bject a n d will be 
mai ntai ne d at t he site.  T his l o g will re mai n c o nfi de ntial a n d will n ot be pr o vi de d t o t he 
S p o ns or, b ut o nl y use d f or refere n ce w he n m o nit ori n g  at t he st u d y site.  
3. 7  
S a m ple Size  
U p t o 5 0  s u bjects wit h n o m ore t ha n 1 5 s u bjects bei n g e nr olle d at a n y o ne site. 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3 5  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
3. 8  
I n vesti g ati o n al Sites 
T he cli nical st u d y will be c o n d ucte d at u p t o si x ( 6) E ur o pea n  i n v esti gati o nal sites. 
3. 9  
D ur ati o n of S u bject P a rtici p ati o n  
Site i nitiati o n a n d i n vesti gat or trai ni n g is esti mate d t o ta ke 3  m o nt hs . T he e nr oll me nt 
peri o d is esti mate d t o ta ke 4  m o nt hs a n d s u bjects will be f oll o we d f or u p t o 1 3  m o nt hs .   
Pr oce d ural a n d 7 -da y dat a  f or re g ulat or y s u b missi o n s h o ul d be a vaila ble a p pr o xi matel y 
5 m o nt hs after first e nr oll me nt.  
T he t otal st u d y d urati o n will be a p pr o xi matel y 2 0  m o nt hs  fr o m t he be gi n ni n g of site 
trai ni n g t o fi nal st u d y f oll o w-u p . 
3. 1 0  S u bject  C o m pleti o n or Wit h dr a w al  
3. 10. 1 St u d y C o m pleti o n  
O nce t he s u bject has c o m plete d t h e fi nal 1 2 m o nt h f oll o w-u p visit t he y are t o be 
e xite d fr o m t he st u d y.   After st u d y c o m pleti o n patie nts will ret ur n t o sta n dar d me dical 
care 
3. 10. 2  V ol u nt ar y W it h dr a w al 
S u bjects ma y v ol u ntaril y wit h dra w fr o m t he st u d y at a n y ti me f or a n y reas o n .  
3. 10. 3  I n vesti g at or Initi ate d wit h dr a w al  
T he  i n vesti gat or ma y wit h draw t he s u bject d ue t o a n y of t he f oll o wi n g sit uati o ns:  
•  a d verse e ve nt ( A E); or  
•  st u d y i n vesti gat or ma y wit h dra w a patie nt fr o m t he st u d y wit h o ut t he patie nt’s 
c o nse nt  if t he i n vesti gat or has a c o n cer n f or t he patie nt’s ri g hts, safet y or 
welfare  
3. 10. 4  D oc u me nt ati o n  
At t he ti me of st u d y wit h dra wal  or c o m pleti o n f or a n y reas o n , t h e st u d y e xit C R F will 
be c o m plete d , i ncl u di n g t he reas o n f or e xit. 
3. 10. 5  C o nti n ui n g Me dic al C are  
S u bjects lea vi n g t he st u d y at a n y ti me will c o nti n ue t o recei ve a p pr o priate me dical 
care wit h o ut prej u dice . 
3. 10. 6  Tre at me nt of Pre g n a ncies I de ntifie d D uri n g S u bject P artici p ati o n  
If a s u bject b ec o mes pre g na nt d uri n g partici pati o n i n t he st u d y, t he patie nt will be 
e xcl u de d fr o m f urt her st u d y assess me nts a n d will ret ur n t o sta n dar d me dical care.  
T hese s u bjects will, h o w e ver, c o nti n ue t o b e f oll o we d f or s afet y.  
3. 10. 7  L ost t o F oll o w -U p  
If t he i n vesti gator has atte m pte d t o c o ntact a s u bject at least t hree ti mes wit hi n 6 0 
da ys a n d recei ve d n o res p o nse, t he s u bject ma y b e c o nsi dere d l ost t o f oll o w -u p .  T he 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3 6  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
i n vesti gat or will d oc u me nt t hat a mi ni m u m of t hree atte m pts were ma de t o c o ntact 
t he s u bject, i ncl u di n g se n di n g a certifie d letter if c urre nt a d dress is k n o w n, pri or t o 
e xiti n g t he s u bject fr o m t he st u d y. 
At t he ti me of c o nfir me d l ost t o f oll o w -u p stat us, t he st u d y e xit C R F will be 
c o m plete d.  
3. 1 1  Pr oce d ure s 
3. 11. 1 I n de x Pr oce d ure  
T he i n vesti gat or will c o nfir m t hat t he f oll o wi n g ha ve bee n ac hi e ve d : 
•  F or w o me n of c hil d beari n g p ote ntial –  a ne gati ve pre g na nc y t est  
•  Baseli ne NI H S S sc ore  
•  T he patie nt is n ot o n a mi o dar o ne  
F A R A P U L S E E n d ocar dial A blati o n pr oce d ure patie nts will u n der g o a nest h esia 
acc or di n g t o i nstit uti o nal pr ot oc ol.  T he y will t he n be pre pare d i n c o n ve nti o nal sterile 
fas hi o n f or a car di ac cat h eterizati o n pr o ce d ure.  Fe m oral vei n access will be o btai ne d 
via Sel di n ger tec h ni q ue.  Tra nsse ptal access t o t he left atri u m will t he n be o btai ne d 
usi n g a c o m merciall y a p pr o ve d s heat h a n d Br oc k e n br o u g h nee dle.  T he tr a nsse ptal 
s heat h will t he n be wit h dra w n, lea vi n g g ui de wire access t o t he left atri u m.  T he 
F A R A D RI V E Steera ble  S heat h  or F A R A D RI V E Deflect a ble S heat h will t he n be 
pre pare d a n d a d va nce d via g ui de wire t o t he left atri u m.  C o m merciall y a p pr o ve d 
m ultielectr o de paci n g cat heters will t he n be place d via c o n ve nti o nal tec h ni q ue  at t he 
i n vesti gat or’s discreti o n.  A baseli ne electr o p h ysi ol o gical assess me nt of p ul m o nar y 
vei n c o n necti o n t o t he left atri u m will be ma de a n d d oc u me nte d via  F A R A W A V E or 
a c o m merci all y a p pr o ve d dia g n ostic cat heter place d  i n eac h a d dressa ble p ul m o nar y 
vei n.  A baseli ne 3 D electr oa nat o mical ma p ma y als o be ma de at t he i n vesti gat or’s 
discreti o n.  T he dia g n osti c cat het er , if use d, will t h e n be re m o v e d fr o m t he 
F A R A D RI V E Steera ble  S heat h  or F A R A D RI V E Deflect a ble S heat h . 
T he F A R A W A V E A bl ati o n Cat heter will t he n be pre pare d a n d a d va nce d o ver t he 
g ui de wire t o t he left atri u m  t hr o u g h t he s heat h.  T he g ui de wire will be a d v a nce d i nt o 
a tar get p ul m o nar y v ei n, t he cat heter s pli nes will be de pl o ye d t o s uit tar get a nat o m y 
b y retracti n g t he de pl o y me nt k n o b, a n d t he de pl o ye d cat het er will be a d v a nce d t o t he 
osti u m of t he tar get p ul m o nar y vei n.  At t he i n vesti gat or’s discreti o n , c o ntr ast 
ve n o gra p h y ma y b e perf or me d t o verif y place me nt of t he cat heter at t he osti u m .  
Car diac paci n g ca pt ur e fr o m t he e xter nal car diac sti m ulat or will be o btai ne d via 
c o n necti o n t o a dia g n osti c cat het er .  O nce paci n g ca pt ure is c o nfir me d, a bl ati o n will 
be perf or me d.  A blati o n d ose will be selecte d at t he i n vesti gat or’s discreti o n i n 
acc or da nce wit h L B L 07 8 4 , F A R A S T A R Ge nerat or User Ma n u al.   
A blati o n wit h t he F A R A W A V E A blati o n Cat heter ma y be re peat e d at t he s a me site 
or at a n ot her t ar get site at t he p h ysicia n’s discreti o n usi n g de pl o y me nt c o nfi g urati o ns 
t o s uit tar get a nat o m y. Eac h a d dres sa ble p ul m o nar y vei n will be a blate d i n t ur n 
be gi n ni n g wit h place me nt of t he g ui de wire, d e pl o y me nt of t he a blati o n cat heter, 
c o nfir mati o n of paci n g ca pt ure, a n d a blati o n.  T he effect of t he a bl ati o n(s) ma y be 
c hec k e d p ost -pr oce d ure b y paci n g ma ne u v ers , E C G rec or di n gs, 3 D electr oa nat o mic 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3 7  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
ma p pi n g, or b y usi n g t he ma p pi n g electr o des o n t h e a blati o n cat het er s pli nes. 
A blati o n usi n g t he F A R A F L E X A bl ati o n Cat heter ma y be p erf or me d t o cl ose ga ps i n 
electrical is olati o n of p ul m o nar y vei ns, f ocall y a blate car diac ar r h yt h mias, or create a 
li ne of a blati o n at t he ca v o -tric us pi d ist h m us ( C TI).  
 
F or a d etaile d des cri pti o n of pr oce d ure w or kfl o w refer t o L B L 0 7 7 1  ( F A R A D RI V E 
Steera ble  S heat h), L B L 0 1 9 3 ( F A R A D RI V E Deflecta ble S heat h), L B L 0 7 7 4  
( F A R A W A V E E n d ocar dial A blati o n Cat heter ), L B L 0 7 7 6  ( F A R A F L E X E n d ocar dial 
A blati o n Cat heter , L B L 0 7 8 4  (F A R A S T A R Ge n erat or ), a n d L B L 0 8 9 2 ( Rec or di n g 
S witc h B o x) .   
3. 11. 2  Re a bl ati o n Pr oce d ure  
Patie nts wit h rec urre nt A F, A F L or A T ma y u n d er g o a sec o n d a blati o n pr oce d u re 
(rea bl ati o n) wit h t he e x p eri me ntal de vices o n or bef ore t h e e n d of t he Bla n ki n g 
Peri o d ( Da y 9 0). T his r ea blati o n pr oce d ure  will f oll o w t he ste ps c o ntai ne d i n Secti o n 
3 . 11 . 1, I n de x Pr oce d ure, as deter mi ne d b y i n vesti gat or discreti o n  t o ac hie ve 
pr ot oc ol -re q uir e d ma p pi n g a n d a n y re q uire d rea bl ati o n.  
3. 11. 3  Bl a n ki n g Peri o d  
T he Bla n ki n g Peri o d c o nsists of Da y 0 (t he d ate of In de x P r oce d ure) t hr o u g h a n d 
i ncl u di n g Da y 9 0.  
D uri n g t he Bla n ki n g Peri o d , a n y rec urre n ce of A F will be d oc u me nte d; h o we ver, 
rec urre nces of A F, A F L or A T d uri n g t his ti me will n ot be c o nsi dere d  T hera pe utic 
F ail ures.   
S u bjects ma y u n der g o o n e re peat a blati o n d uri n g t he Bla n ki n g Peri o d  wit h o ut 
creati n g a T hera pe utic F ail ure, f oll o wi n g t he pr oce d ure detaile d i n t he prece di n g 
secti o ns. T hi s ma y occ ur d uri n g t he R e ma p P r oce d ure or at a n ot her pr oce d ure as 
cli nicall y i n dicate d.   
If a sec o n d re p eat a bl ati o n pr oce d ure is perf or me d d uri n g t his ti me, or a n y n o nst u d y 
de vice is use d f or car diac a blati o n, t he s u bjects will be c o nsi dere d a T hera p e utic  
F ail ure b ut will re m ai n i n t he st u d y.  
T o war ds t he e n d of t he Bla n ki n g Peri o d , a n y A F D treat me nt will be disc o nti n ue d 
u nless t he I n vesti gat or dee ms t he wit h dra wal of A F D treat me nt n ot t o be i n t he best 
i nterests of t he patie nt. 
3. 11. 4  Arr h yt h mi a C ore L a b  
A n Arr h yt h mia C ore L a b ( A C L) will o versee t he pr o visi o n, c ollecti o n a n d a nal ysis of 
data fr o m t he E v e nt M o nit ors a n d H olter M o nit ors s pecifie d i n t his pr ot oc ol.  
•  T he s u bject will be i nstr ucte d o n t he use of a n E ve nt M o nit or  at or bef ore t h e  
Da y 9 0 f oll o w -u p  visit. Eit her A C L or t he site will pr o vi de t he s u bject wit h a n 
E ve nt M o nit or n ot later t ha n Da y 9 0  t o be us e d t hr o u g h t he re mai n d er of t h e 1 2 -
m o nt h f oll o w -u p i nter val f or wee kl y sc he d ule d a n d a d h oc s y m pt o matic 
m o nit ori n g.  T he E ve nt M o nit or will be ret ur ne d t o t he A C L or t he site  at t he 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3 8  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
ti me of t he s u bject’s e xit fr o m t he st u d y. E C G data fr o m t he E ve nt Mo nit or will 
be a nal yz e d b y t he A C L . 
•  T he s u bject will be i nstr ucte d o n t he use of a 2 4 -h o ur c o nti n u o us E C G ( H olter) 
m o nit or  pri or t o t he 6-M o nt h a n d if nee de d t h e 1 2 -M o nt h H olter m o nit ori n g . 
T he A C L or t he site will pr o vi de  t he s u bject wit h a H olter m o nit or  wit hi n t he 
s pecifie d wi n d o w f or t he 6 a n d 1 2 -M o nt h Visits .  T he d e vice will be w or n b y 
t he s u bject f or a si n gle 2 4-h o ur peri o d a n d t he n ret ur ne d t o t he A C L or t he site . 
E C G data fr o m t his m o nit or will be a nal yze d b y t h e A C L .   
3. 1 2  Sc he d ule  of E ve nts a n d Assess m e nts  
S u bjects will c o m plete t he f oll o wi n g visits a n d assess me nts as i n dicate d bel o w a n d as 
s u m marize d i n Secti o n 3. 1 3  T a ble 3  S u m m ar y  of St u d y Assess m e nts .   
3. 12. 1 B aseli ne  
B aseli ne data will  be c oll ecte d  wit hi n 3 0 da ys of t he date of e nr oll me nt u nless 
ot her wise s pecifie d. T his data will i ncl u de: 
•  Me dical hist or y  
•  A F D a n d a ntic oa g ulati o n me dicati o n hist or y  
•  Pre g na nc y test ( all w o me n of c hil d-beari n g p ote ntial ) 
•  1 2 -lea d E C G 
•  Car diac C T or M RI  a d e q uate t o c haracterize left atrial a n d p ul m o nar y vei n 
di me nsi o ns  
•  T E E or ot her g ui deli ne -rec o m me n de d i ma gi n g m o dalit y f or e xcl usi o n of l eft atrial 
t hr o m b us 
•  N Y H A Classificati o n  
•  NI H S S  sc ore 
•  C H A 2D S 2-V A Sc  sc ore 
•  E Q -5 D -3 L q u alit y of life assess me nt  
•  F or Ne ur ol o gic Assess m e nt S u b p o p ulati o n s u bjects: Cra nial M RI  
3. 12. 2  I n de x Pr oce d ure 
T he I n de x Pr oce d ure will be perf or me d acc or di n g t o Secti o n 3. 1 1. 1, I n de x 
Pr oce d ure . P r oce d ural data will be c ollecte d  i n cl u di n g: 
•  Pre g na nc y test ( all w o me n of c hil d beari n g p ote nti al  if baseli ne pre g na nc y t est 
o btai ne d m ore t ha n 1 4 da ys pri or t o pr oce d ure ) 
•  P ost -a blati o n 3 D electr oa nat o mical ma ps  
•  P ost -a blati o n f l u or osc o pic exa mi nati o n of d ia p hra g m m oti o n t o assess p hre nic 
ner ve res p o nse  
•  A d verse E v e nts  
•  Pr oce d ural ti mes  
•  Lesi o n set data  
•  De vice d eficie n cies  a n d malf u ncti o ns  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 3 9  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
3. 12. 3  Pre -Disc h ar g e  
Pri or t o h os pital disc har ge t he st u d y data will be c ollecte d  i ncl u di n g: 
•  A d verse E v e nts  
•  Dat a re g ar di n g t he use, c ha n ges i n or disc o nti n uati o n of a ntic oa g ulati o n, rate 
c o ntr ol a n d/ or a ntiarr h yt h mic me dicati o ns . 
•  Car diac r h yt h m as d eter mi ne d b y a 1 2 -lea d E C G 
•  Occ urre nce, date, i n dicati o n a n d o utc o me of a n y c ar di o versi o n(s)  
•  At t he i n vesti gat or’s disc reti o n: a p ost-pr oce d ural me diasti nal ga d oli ni u m -
e n ha nce d M RI  
•  Str o ke/ TI A assess me nts  
o  NI H S S sc ore  
o  A ne ur ol o gic e x a mi nati o n will be perf or me d a n d rec or de d if: 
▪ If t he NI H S S sc ore has i ncreas e d b y 2 or m or e p oi nts  
▪ If t here is a cli nical s us pi ci o n of str o ke or TI A 
▪ A p ost -pr oce d ure cra nial M RI s h o ws c h a n ges fr o m a pre -pr oce d ure 
M RI (s ee Secti o n 3. 1 2. 1 1, Ne ur ol o gic Assess me nt  S u b p o p ulati o n)  
•  F or Ne ur ol o gic Assess m e nt S u b p o p ulati o n s u bjects: Cra nial M RI  
•  A ntic oa g ulati o n M o nit ori n g:  
o  F or s u bjects o n N O A C, p e rf or m a P T T a n d, at t he i n vesti gat or’s discreti o n, a 
t hr o m bi n ti me  
o  F or s u bjects o n warfari n, assess me nt of I N R t hera pe utic le vels  
3. 12. 4  7 -D a y Tele p h o ne Assess me nt  
S u bjects will be c o ntacte d b y tele p h o ne bet w ee n Da y 7 a n d 1 0 p ost -I n d e x Pr oce d ure.  
St u d y data will be c ollecte d b y i nter vie w, i ncl u di n g:  
•  A d verse E v e nts  
•  S y m pt o ms of rec urre nt arr h yt h mia  
•  Data re g ar di n g t he use, c ha n ges i n or disc o nti n uati o n of a ntic oa g ulati o n, rate 
c o ntr ol a n d/ or a ntiarr h yt h mic me dicati o ns.  
•  Car di o versi o ns , a blati o ns or h os pital a d missi o ns  si nce last visit 
 
3. 12. 5  3 0 -D a y  Visit  
Dis c har ge d s u bj ects will ret ur n f or a n offi ce visit 3 0 da ys ( ± 7 da ys) p ost -a blati o n 
treat me nt.  ( A n y su bje ct w h o c o nti n ues t o be h os pitalize d 3 0 da ys p ost-a blati o n will 
ha ve t heir 3 0 -Da y Visit assess me nt perf or m e d i n-h os pital) .  St u d y data will be 
c ollecte d i ncl u di n g: 
•  A d verse E v e nts  
•  S y m pt o ms of rec urre nt arr h yt h mia  
•  Data re g ar di n g t he use, c ha n ges i n or disc o nti n uati o n of a nt ic oa g ulati o n, rate 
c o ntr ol a n d/ or a ntiarr h yt h mic me dicati o ns.  
•  Car diac r h yt h m as d eter mi ne d b y a 1 2 -lea d E C G at t he ti me of t he visit 
•  Car di o versi o ns , a blati o ns or h os pital a d missi o ns si nce last visit 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 4 0  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
•  Heart fail ure stat us as assesse d b y N Y H A classificati o n a t t he ti me of visit 
 
 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 4 1  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
3. 12. 6  Re a bl ati o n Pr oce d ure  
A st u d y s u bject ma y u n der g o o ne rea blati o n usi n g t he e x peri me ntal  d e vice s w it h o ut 
c o nstit uti n g  a t hera pe utic fail ure if t hat r ea blati o n occ urs  o n or b ef ore t he e n d of 
bla n ki n g ( da y 9 0).  I n s u c h cases , t h e f oll o wi n g data will be c ollecte d: 
•  All data re q uir e d f or t he I n d e x Pr oce d ure will be gat here d, utilizi n g t he 
Rea blati o n  Pr oce d ure  C R F pa ges.  
•  3 D electr o a nat o mical r e ma p pi n g pr oce d ure will c haracteri ze t he stat us of P VI 
f or eac h vei n, a n d eac h a d diti o nal lesi o n t y pe perf or me d at t he I n d e x Pr oce d ure 
t o c haracteriz e lesi o n d ura bilit y. 
•  A n y electrical ga ps ma y be treate d at t he i n vesti gat or’s discreti o n usi n g st u d y 
de vices, or if n ecess ar y, a c o m merci all y a p pr o ve d a blati o n de vice ( w hic h 
c o nstit utes  a T hera p e utic F ail ure). 
•  F or patie nts w h o recei ve d e xtra -P V a bl ati o n at i n de x, i ncl u di n g t h ose recei vi n g 
a blati o n of t he C TI, t he persiste nce of n o nc o n d ucti vit y i n tar gete d tiss ue will be 
e val uate d wi t h eit her paci n g ma ne u vers or electr o a nat o mical ma p pi n g. 
 
Pr oce d ure -s pecifi c data will be c ollecte d i ncl u di n g: 
•  Pr oce d ural ti mes  
•  Lesi o n set data  
•  De vice d eficie n cies  a n d malf u ncti o ns  
 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 4 2  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
 
3. 12. 7  9 0 -D a y Visit  
S u bjects will ret ur n f or a n office visit at Da y 9 0 ± 1 4  da ys f oll o wi n g t he I n de x 
Pr oce d ure .   
E ve nt M o nit or  Trai ni n g : Wit hi n t he 9 0 ± 1 4 da y wi n d o w f or t his visit, t he s u bject will 
recei v e trai ni n g re g ar di n g t he use of, a n d t he i m p orta nce of, e ve nt m o nit ori n g. T he 
e ve nt m o nit or s hall  be use d f or wee kl y sc h e d ule d a n d a n y s y m pt o matic u nsc he d ule d 
m o nit ori n g  t hr o u g h o ut t he re mai n der of st u d y f oll o w-u p.  
A F Ds : I n ge n eral, A F Ds s h o ul d be st o p pe d bef ore Da y 1 0 4 (t he e n d of t he 9 0-Da y 
visit wi n d o w) t o all o w assess me nt of off -dr u g free d o m fr o m rec urre nt A F. H o we ver,  
A F Ds ma y b e c o nti n ue d if t he i n vesti gat or deter mi nes t hat t his is i n t he s u bject’s best 
i nterest. 
St u d y data will be c ollecte d at t he 9 0-Da y Visit  i ncl u di n g: 
•  A d verse E v e nts  
•  S y m pt o ms of rec urre nt  arr h yt h mia  
•  If eit her t he p ost-I n de x Pr oce d ure or Rea blati o n Pr oce d ure fl u or osc o pies  
i n dicate d di mi nis he d p hre nic ner ve res p o ns e , a n d res ol uti o n has n ot bee n 
pre vi o usl y de m o nstrate d, a re peat f l u or osc o pi c ex a mi nati o n  
•  Data re g ar di n g t he use, c ha n ges i n or disc o nti n uati o n of a ntic oa g ulati o n, rate 
c o ntr ol a n d/ or a ntiarr h yt h mic me dicati o ns  
•  Car diac r h yt h m as deter mi ne d b y a 1 2 -lea d E C G at t he ti me of t he visit  
•  Car di ac C T or M RI sca n t o assess t he pate nc y of t he p ul m o nar y vei ns  
•  Car di o versi o ns , a blati o ns or h os pital a d missi o ns si nce last visit 
•  Heart fail ure stat us as assesse d b y N Y H A classificati o n at t he ti me of visit  
•  A ntic oa g ulati o n M o nit ori n g:  
o  F or s u bjects o n N O A C , p erf or m a P T T a n d, at t he i n vesti gat or’s 
discreti o n , a t hr o m bi n ti me  
o  F or s u bjects o n warfari n, assess me nt of I N R t hera pe utic le vels  
3. 12. 8  6 -M o nt h  Visit  
S u bjects will ret ur n f or a n office visit 6 m o nt hs ( 1 8 0 da ys ± 3 0 da ys) f oll o wi n g t he 
In d e x Pr oce d ure .   
H olter M o nit or Trai ni n g : Wit hi n t he 1 8 0 ± 3 0 da y wi n d o w f or t his visit, t his visit, t he 
s u bject will recei v e trai ni n g re gar di n g t he us e of, a n d t he i m p orta nce of, 2 4 h o ur 
c o nti n u o us E C G m o nit ori n g.  T he H olter M o nit or will be use d f or a 2 4 h o ur  
m o nit ori n g wit hi n t he visit wi n d o w.  
E ve nt M o nit or C o m plia nce : Wit hi n t he 1 8 0 ± 3 0 da y wi n d o w f or t his visit, a n d 
prefera bl y at t he visit, E v e nt M o nit or c o m plia nce will be re vie we d f or wee kl y 
sc he d ule d a n d a d h oc s y m pt o matic m o nit ori n g a n d retrai ni n g of t h e s u bject pr o vi de d 
as nee de d.  
St u d y data will be c ollecte d at t he 6-M o nt h Visit  i ncl u di n g: 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 4 3  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
•  A d verse E v e nts  
•  S y m pt o ms of rec urre nt arr h yt h mia  
•  If eit her t he p ost-In de x P r oce d ure or Rea blati o n  P r oce d ure fl u or osc o pies 
i n dicate d di mi nis he d p hre nic ner ve res p o ns e , a n d res ol uti o n has n ot bee n 
pre vi o usl y de m o nstrate d,  a re peat f l u or osc o pi c ex a mi nati o n  
•  Data re g ar di n g t he use, c ha n ges i n or disc o nti n uati o n of a ntic oa g ulati o n, rate 
c o ntr ol a n d/ or a ntiarr h yt h mic me dicati o ns  
•  Car diac r h yt h m as deter mi ne d b y a 1 2 -lea d E C G at t he ti me of t he visit 
•  Car di o versi o ns , a blati o ns or h os pital a d missi o ns si nce last visit 
•  Heart fail ure stat us as assesse d b y N Y H A classificati o n at t he ti me of visit  
•  A ntic oa g ulati o n M o nit ori n g:  
o  F or s u bjects o n N O A C , p erf or m a P T T a n d, at t he i n vesti gat or’s 
discreti o n , a t hr o m bi n ti me  
o  F or s u bjects o n warfari n, assess me nt of I N R t hera pe utic le vels  
3. 12. 9  1 2-M o nt h  Visit  
S u bjects will ret ur n f or a n office visit 1 2 m o nt hs ( 3 6 5 da ys ± 3 0 da ys) f oll o wi n g t he 
In d e x Pr oce d ure .  D uri n g t his visit, t he s u bject will recei ve trai ni n g re g ar di n g t he use 
of, a n d t he i m p orta nce of, 2 4 h o ur c o nti n u o us E C G m o nit ori n g.  
H olter M o nit or Trai ni n g : Wit hi n t he 3 6 5 da ys ± 3 0 da y wi n d o w f or t his visit, t his 
visit, t he s u bject will recei ve trai ni n g r e g ar di n g t h e use of, a n d t h e i m p orta nce of, 2 4 
h o ur c o nti n u o us E C G m o nit ori n g. T he H olter M o nit or will be use d f or a 2 4 h o ur 
m o nit ori n g wit hi n t he visit wi n d o w.  
St u d y data will be c ollecte d at t he 1 2 -M o nt h  Visit  i ncl u di n g: 
•  A d verse E v e nts  
•  S y m pt o ms of rec urr e nt arr h yt h mia  
•  If eit her t he p ost-I n de x Pr oce d ure or Rea blati o n  Pr oce d ure fl u or osc o pies 
i n dicate d di mi nis he d p hre nic ner ve res p o ns e , a n d res ol uti o n has n ot bee n 
pre vi o usl y de m o nstrate d, a re peat f l u or osc o pi c ex a mi nati o n  
•  Data re g ar di n g t he use, c ha n ges i n or disc o nti n uati o n of a ntic oa g ulati o n, rate 
c o ntr ol a n d/ or a ntiarr h yt h mic me dicati o ns . 
•  Car diac r h yt h m as deter mi ne d b y a 1 2 -lea d E C G at t he ti me of t he visit 
•  Car di o versi o ns , a blati o ns or h os pital a d missi o ns si nce last visit  
•  Heart fail ure stat us as assesse d b y N Y H A classificati o n at t he ti me of visit  
•  E Q -5 D -3 L q u alit y of life assess me nt  
•  A ntic oa g ulati o n M o nit ori n g:  
o  F or s u bjects o n N O A C , p erf or m a P T T a n d, at t he i n vesti gat or’s 
discreti o n , a t hr o m bi n ti me  
o  F or s u bjects o n w arfari n, assess me nt of I N R t hera pe utic le vels  
3. 12. 10  U nsc he d ule d Visit s 
A n y u nsc he d ule d f oll o w -u p visits t hat occ ur t hr o u g h o ut t he st u d y, ot her t ha n r o uti ne 
f oll o w-u p visits per t he i nstit uti o n’s or i n vesti gat or’s n or mal sta n dar d of care, s hall be 
d oc u me nte d .  St u d y data will be c ollecte d  i ncl u di n g: 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6  R E VI SI O N C  
 
P A G E 4 4  
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
•  A d verse E v e nts  
•  S y m pt o ms of rec urre nt arr h yt h mia  
•  Car diac r h yt h m as d eter mi ne d b y a 1 2 -lea d E C G at t he ti me of t he visit  
•  E ve nt M o nit or c o m plia nce will be re vi e we d f or wee kl y sc he d ule d a n d a d h oc 
s y m pt o matic m o nit ori n g a n d retr ai ni n g of t he s u bject pr o vi de d as n ee d e d . 
•  Car di o versi o ns , a blati o ns or h os pital a d missi o ns si nce last visit  
•  Heart fail ure stat us as assesse d b y N Y H A clas sificati o n at t he ti me of visit 
•  A ntic oa g ulati o n M o nit ori n g:  
o  F or s u bjec ts o n N O A C , p erf or m a P T T a n d, at t he i n vesti gat or’s 
discreti o n , a t hr o m bi n ti me  
o  F or s u bjects o n warfari n, assess me nt of I N R t hera pe utic le vels  
 
3. 12. 11 Ne ur ol o gic Assess m e nt S u b p o p ul ati o n  
A n i n vesti gat or ma y ele ct t o ha ve a seri es of st u d y s u bjects u n der g o pre - a n d p ost -
a blati o n cra nial M RIs t o assess t he occ urre n ce of s u bcli nical e m b oli ( S C E) d uri n g t he 
I n d e x Pr oce d ure. T h e p ost-a blati o n M RI will be o btai ne d bet wee n 2 4 a n d 7 2 h o urs 
f oll o wi n g t he c o ncl usi o n of t he a blati o n pr oce d ure.  
 
 

 F A R A P U L S E  F A R A -F R E E S T U D Y  
D E C E M B E R  2 0 1 9  
C S 0 7 6 6,  R E VI SI O N B  
 
P A G E 4 5  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
3. 1 3  Sc he d ule of St u d y  Assess m e nts  
T a ble 3 . S u m m ar y of St u d y Assess m e nts  
Ass ess m e nt  
B as eli ne  
Pr o ce d ure  
Pre - 
Dis c h ar ge  
7 -D a y  
C all  
3 0 -D a ys P ost -
Pr o ce d ure  ( ± 
7 d a ys)  
R e a bl ati o n  
Pr o ce d ure 
(if 
re q ui re d) 
9 0 -D a y 
F oll o w -u p  
( 9 0 ± 1 4 
d a ys)  
6 -M o nt h  
( 1 8 0 ± 3 0 
d a ys)  
1 2 -M o nt h  
( 3 6 5 ± 3 0 
d a ys)  
U nsc he d ule d  
Me di cal Hist or y , C H A2D S 2-V A Sc  
X  
 
 
 
 
 
 
 
 
 
A F D a n d A ntic oa g ul a nt Me di cati o ns  
X  
 
X  
X  
X  
X  
X  
X  
X  
X  
S y m pt o ms of rec urre nt arr h yt h mi a  
 
 
 
X  
X  
X  
X  
X  
X  
X  
Hist or y of c ar di o v ersi o ns , a bl ati o ns, 
h os pit al a d missi o ns si n ce last v isit 
 
 
X  
X  
X  
X  
X  
X  
X  
X  
Pre g n a n c y t est (f or fe mal es of 
c hil d b eari n g p ot e ntial)  
X  
X  
 
 
 
X  
 
 
 
 
1 2 -lea d E C G 
X  
 
X  
 
X  
X  
X  
X  
X  
X  
2 4 -H o ur C o nti n u o us E C G M o nit or (e. g., 
H olt er)  
 
 
 
 
 
 
 
X  
X  
 
Car di ac C T /M RI  f or L A a n d P V 
di me nsi o ns  
X  
 
 
 
 
X  
 
 
 
 
Me di asti n al M RI  
 
 
X 1 
 
 
 
 
 
 
 
T E E or ot her i ma gi n g m o dalit y (t o 
e x cl u de l eft atri al t hr o m b us) 
X  
 
 
 
 
 
 
 
 
 
Electr o a n at o mical Ma p pi n g  
 
X  
 
 
 
X  
 
 
 
 
E v e nt M o nit or  rea di n ess/ c o m pli a n ce 
 
 
 
 
 
X  
X  
X  
X  
X  
NI H S S  
X  
 
X  
 
 
 
 
 
 
 
N e ur ol o gi c e x a m  
 
 
X 2 
 
 
 
 
 
 
 
Cra ni al M RI  
X 3 
 
X 3 
 
 
 
 
 
 
 
N Y H A Cl assifi cati o n  
X  
 
X  
 
X  
X  
X  
X  
X  
X  
Fl u or os c o pic E x a mi n ati o n of Di a p hra g m  
 
X  
 
 
 
X  
X 4 
X 4 
X 4 
 
A nti c o a g ulati o n M o nit ori n g  
 
 
X 5 
 
X 5 
X 5 
X 5 
X 5 
X 5 
X 5 
E Q -5 D -3 L Q o L assess me nt  
X  
 
 
 
 
 
 
 
X  
 
A d verse E v e nts  
 
X  
X  
X  
X  
X  
X  
X  
X  
X  
1   At i n vesti gat or’s discreti o n  
2   If NI H S S sc ore has i ncrease d b y 2 or m ore p oi nts or if cli nical s us pici o n of str o ke/ TI A 
3   I n Ne ur ol o gic Assess me nt S u b p o p ulati o n o nl y 
4   If t he I n de x Pr oce d ure or Re ma p Pr oce d ure st u d y i n dicated  decrease d p hre nic ner ve f u ncti o n a n d res ol uti o n has n ot yet bee n de m o nstrate d.  
5   I N R or P T T (as a p plica ble f or patie nt o n he pari n or N O A Cs); A C T f or pr oce d ural m o nit ori n g 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 4 6  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
4.  Be n efit Ris k A ssess me nt 
T he S p o ns or has c o n d uct e d a n a n al ysis of t he be n efits a n d ris ks of t he 
F A R A P U L S E A blati o n S yste m Pl us  a n d a blati o n pr oce d ure  as des cri be d b el o w .  
T he c o ncl usi o n of t his re vie w is t hat t he s u bject i n vesti gati o n is j ustifie d beca use 
t he o verall p ote ntial be n efit t o t he p o p ulati o n o ut wei g hs t he ris ks. 
4. 1  
P ote nti al A d verse E ve nts  
T he f oll o wi n g a ntici pate d  a d verse e ve nts ha v e bee n i de ntifie d as p ossi ble 
c o m plicati o ns of perc ut a ne o us atrial fi brillati o n a blati o n pr oce d ures i n ge neral as 
well as  wit h t he F A R A P U L S E A blati o n S yste m Pl us : 
•  Access site c o m plic ati o ns (e. g., he mat o ma, pse u d o -a ne ur ys m , lacerati o n, 
blee di n g ) p ote ntiall y re q uiri n g s ur gical i nter ve nti o n  
•  A ir e m b olis m 
•  Aller gic reacti o n or fe ver res ulti n g fr o m c o ntact wit h cat heters  
•  A ne mia  
•  Arr h yt h mia, p ote ntiall y r e q uiri n g car di o v ersi o n , d efi brillati o n, or r h yt h m 
ma na ge me nt de vi ce  
•  Arteri o ve n o us fist ulae  
•  Bac k pai n  
•  Be d s ores  
•  Blee di n g, he mat o ma, he m orr ha ge or a ne ur ys m at vasc ular access sites  
•  Bl o o d press ure c h a n ges i ncl u di n g h y p ote nsi o n or h y perte nsi o n  
•  C or o nar y art er y or v ei n i nj ur y  
•  Car diac ta m p o na d e  or perf orati o n  
•  Car diac arrest or car di ac fail ure  
•  Cat heter e ntr a p me nt  
•  Car di o ge nic s h oc k  
•  C o n d ucti o n  s yste m i nj ur y res ulti n g i n si n us arrest or heart bl oc k, eit her 
tra nsie nt or per m a ne nt, p ote ntiall y re q uiri n g pace ma ker i nserti o n 
•  C o n gesti ve h eart fail ure  
•  Deat h  
•  Dr u g aller gic reacti o n or si de effects (e. g., fr o m c o ntrast, ster oi ds, a nal gesics, 
a nest hetics , a ntic o a g ula nts, se dati ves, etc.) 
 
•  E m b olis m d ue t o prese nce of t hr o m b us or i ntr o d ucti o n of air  
•  Es o p ha geal i nj ur y , ulcer or fist ula 
•  He m orr ha g e  
•  He m o d y na mic c o m pr o mise  
•  He m o peric ar di u m  
•  He m o perit o ne u m  
•  He m ot h ora x  
•  L ocal i nfecti o n, s yste mic i nfecti o n, a n d/ or se ps is 
•  M uscle c o ntracti o ns  d ue t o electric sti m ulati o n  
•  M y ocar dial i nfarcti o n / tra nsie nt isc he mia  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 4 7  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
•  Ner ve d a ma ge  
•  Or ga n fail ure  
•  Pai n  
•  Perf orati o n (e. g., of dia p hra g m, li ver, l u n g, a n d/ or vessels).  
•  Pericar dial irritati o n  
•  Pericar dial eff usi o n  
•  Pericar ditis  
•  Perit o nitis  
•  P hre nic ner ve i nj ur y  wit h paral ysis of t he dia p hra g m a n d breat hi n g 
i m pair me nt 
•  P ne u m o me diasti n u m  
•  P ne u m o pericar di u m  
•  P ne u m o perit o ne u m  
•  P ne u m ot h ora x  
•  P ul m o nar y vei n i nj ur y or ste n osis 
•  Ris k of ca ncer or birt h defect/ har m t o fet us fr o m x -ra y e x p os ure  
•  S ki n b ur ns/irritati o n fr o m x -ra y e x p os ure  
•  Str o ke/tra nsie nt isc he mic attac k  
•  S ur gical pr oce d ure t o r e m o ve retai ne d cat heter 
•  T hr o m b osis  
•  Vessel da ma g e, dissecti o n, or occl usi o n.  
4. 2  
P ote nti al Ris ks  
As detaile d i n Secti o n 1 .3 , S u m m ar y of F A R A P U L S E Cli nic al St u dies, the ris k 
pr ofile ass ociat e d wit h t he F A R A P U L S E A blati o n S yste m Pl us  a n d t he a blati o n 
pr oce d ure is e x pecte d t o be c o nsiste nt wit h si milar de vices c urre ntl y i n cli nical use 
f or perc uta ne o us car diac a blati o n f or treat me nt of par o x ys mal atrial fibrillati o n.   
T he F A R A P U L S E A blati o n S yste m Pl us  is a P ulse d Fiel d A blati o n  (P F A ) a blati o n 
s yste m t hat pr o d uces c o ntin u o us tra ns m ural car diac lesi o ns t o treat atrial fi brillati o n 
usi n g a n a blati o n pr oce d ure t hat is si milar t o ot her c o m merci all y a vaila ble 
p erc uta n e o us a blati o n c at heters .  M ore s p ecificall y:  
•  T he de vice s yste m is use d d uri n g perc uta ne o us e n d ocar dial a bl ati o n pr oce d ures  
li ke ot her c o m merciall y a p pr o ve d cat heter s yste ms.   
•  T he de vice s yste m is c o m p ose d of si milar bi oc o m pati ble materials . 
•  T he de vice s yste m is a n o n -t her mal a blati o n tec h n ol o g y wit h tar gete d car diac 
tiss ue s pecific mec h a nis m of a blati o n. 
•  T he de vice us es t he sta n dar d perc uta ne o us  tec h ni q ues f or a blati o n pr o ce d ures. 
•  T he de vice utilizes a sta n dar d irre v ersi ble el ectr o p orati o n ge nerat or t o deli v er 
e ner g y i n t he f or m of a bl ati o n d ose .   
 
A f u n da me ntal differe nce bet wee n t he F A R A P U L S E A blati o n S yste m Pl us  a n d 
ot her c o m merciall y a p pr o ve d atrial fi brillati o n a blati o n  s yste ms is t hat t he P ulse d 
Fiel d A blati o n  or irre versi ble electr o p orati o n e ner g y is deli vere d t hr o u g h el ectr o des 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 4 8  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
e m be d de d i n t he e n d o car dial a blati o n cat heter f or deli ver y of s uc h e ner g y i n t he 
p ul m o nar y vei ns.  
As s uc h, t he p ote ntial ris ks are r o u g hl y e q ui vale nt t o t h ose ass ociate d wit h 
c o m merciall y rel ease d s yste ms bei n g use d f or perc uta ne o us car diac a blati o n 
pr oce d ures .  C urre ntl y , t he c o m plicati o n rates f or c o m merciall y av aila ble cat heters 
are l o w a n d h a ve d ecli ne d as p h ysicia ns ha ve c o nti n ue d t o lear n m ore a b o ut car diac 
a blati o n tec h ni q ues .  F urt her m ore, F A R A P U L S E , I n c. has c o n d u cte d be n c h a n d i n -
vi v o testi n g t o e ns ure safe use of t he d e vice d uri n g cli nical i n vesti gati o n a n d is i n 
c o m plia nce wit h t he a p plica ble re q uire me nts of t h e Me dical D e vice Directi ve 
9 3/ 4 2/ E E C .   
4. 3  
P ote nti al Be nefits  
T here are n o g u ar a ntee d  be nefits fr o m partici pati o n i n t his st u d y .  I nf or mati o n 
gai ne d fr o m t he c o n d uct of t his st u d y ma y als o be of be nefit t o ot her p ers o ns wit h 
t he sa me me dical c o n diti o n. 
T his  st u d y of u p t o 5 0  patie nts will ha ve t he f oll o wi n g p ote ntial  be nefits:  
•  T o pr o vi de treat me nt t o s u bjects wit h P A F usi n g a n i n vesti gati o nal de vice 
w hic h has de m o nstrate d t he a bilit y t o is olate p ul m o nar y vei ns a n d re d uce 
t he s u bse q ue nt occ urre n ce of s y m pt o matic atrial fi brillati o n i n a s mall 
n u m ber of patie nts ; 
•  T o ge n erate a d diti o nal data de m o nstrati n g t hat t he e n d ocar di al creati o n of 
electricall y is olati n g lesi o ns via P ulse d F iel d A blati o n  (P F A ) cat heter 
a blati o n a p plie d usi n g t he F A R A P U L S E  E n d ocar dial A blati o n S yste m is a 
safe a n d p ot e ntiall y effecti ve treat me nt f or dr u g-resista nt, rec urre nt, 
s y m pt o matic par o x ys mal atrial fi brillati o n ( P A F) ; 
•  T o assess t he safet y a n d effecti ve ness  of t he F A R A F L E X A bl ati o n Cat heter 
f or f ocal a blati o n i n acc orda nce wit h its pr o p ose d i n dicati o n f or use ; 
•  T o assess t he pr ot oc ol el e me nts a n d desi g n f or s u bse q ue nt use i n a gl o bal 
m ulti -ce nter pi v otal t rial. 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 4 9  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
5.  St atistic al A n al ysis  a n d Re p orti n g  
A S tatistical A nal ysis P la n ( S A P) will be pre pare d t hat g o ver n s t he c ollecti o n, 
a nal ysis a n d re p orti n g of t he data fr o m t his i n vesti gati o n. T his secti o n s u m marizes 
t he esse ntial ele me nts of t hat pla n. 
5. 1  
Ge ner al St atistic al C o nsi der ati o ns  
All statistical a nal yses will be perf or me d usi n g v ali date d statistical s oft ware.  
C o nti n u o us varia bles will be s u m marize d usi n g sta n dar d q ua ntitati ve statistics: 
n u m ber of a v aila ble  o bser vati o ns, mea n, sta n dar d de viati o n, me dia n, q uartiles a n d 
ra n ge ( mi ni m u m a n d ma xi m u m o bser ve d val ues). T he n u m ber of missi n g 
o bser vati o ns will als o be s pecifie d.  
Cate g orical varia bles will be s u m marize d usi n g cl assical fre q ue nc y statistics: 
n u m ber of a v aila ble  o bser vati o ns a n d perce nta ges b y cate g ories. Perce nt a ges will 
be calc ul ate d o n t he n u m ber of a v aila ble o bser vati o ns. T he n u m ber of missi n g 
o bser vati o ns will als o be s pecifie d.  
W he n a p plica ble, bilateral as y m pt otic or e xact c o nfi de nce i nter vals f or bi n o mial 
distri b uti o ns will be calc ulate d at t he 9 5 % le vel.  
A f ull data listi n g will be pre pare d. Dat a will be p o ole d fr o m all st u d y sites.   
All relate d a n d res ulti n g re p orts, d oc u me nts a n d d ata will be pr o d uce d a n d 
mai ntai ne d i n s uc h a wa y as t o e ns ure t heir c o ntr ol a n d t he pr otecti o n of s u bject 
pri vac y as f ar as is reas o na bl y practica ble.  Dat a files a n d a nal ytic re p orts will be 
arc hi ve d acc or di n g t o re q ui site re g ulat or y sta n dar ds. 
5. 2  
C o ntr ol of S yste m atic Err or a n d Bi as  
S u bjects are n ot ra n d o mi ze d i n t his si n gle ar m st u d y a n d  t heref ore mas ki n g is n ot 
ac hie va bl e.  E rr or a n d bi as are b ei n g c o ntr olle d b y se veral mea ns, i ncl u di n g a 
c o m pre he nsi ve s et of st u d y pr oc e d ures as defi ne d i n t he pr ot oc ol t o e ns ure 
c o nsiste nt ma na ge me nt a n d o utc o me meas ure assess me nt.  F oll o w -u p H olter 
m o nit ori n g a n d e ve nt m o nit ori n g data, a n d all M RI/ C T di me nsi o ns of P Vs, will be 
assesse d o bjecti vel y b y t hir d parties acc or di n g t o sta n dar d cli nical pr ot o c ols .  
Pri mar y effecti ve ness a n d safet y o utc o mes will be re vie we d b y a n i n de pe n de nt 
Cli nical E ve nts –  Data M o nit ori n g C o m mittee  (C E D M C ).  A c o m plete St u d y 
Re p ort will all o w scie ntific a n d cli nical r e vie wers t o i n de pe n de ntl y assess p ote ntial 
err or a n d bias. 
St u d y o utc o mes will be re vie we d a n d a dj u dicat e d b y a n i n de pe n de nt Cli nical 
E ve nts a n d Data M o nit ori n g C o m mittee ( C E D M C) m ore f ull y descri be d i n Secti o n 
9. 1 0 , Cli nic al E ve nts a n d D at a M o nit ori n g C o m mittee. 
5. 3  
S a m ple Size J ustific ati o n   
T his i n vesti gati o n is t h e ne xt i n a pr o gressi ve s eri es assessi n g t he perf or ma nce of 
t he F A R A P U L S E A blati o n S yste m Pl us . T his is a pil ot st u d y wit h n o f or mal 
h y p ot hesis testi n g a n d t heref ore n o re q uire d s a m ple size.  St u d y res ults will be 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 5 0  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
prese nte d usi n g des cri pti ve statistics.  R es ults fr o m t his st u d y will be use d  t o i nf or m 
a n d desi g n a d diti o nal cli nical st u dies.  
5 0 s u bjects wit h a tar gete d e nr oll me nt of at least  3 0 at ne w sites  w h o ha v e n ot 
perf or me d P F A bef ore , utilizi n g t he u p date d c o m mercial desi g n i n vesti gati ve 
de vices all o ws ass ess me nt of t he re vise d de vi ces, c o nfir ms trial para meters a n d 
pr o vi des fee d bac k o n t he trai ni n g a n d o versi g ht of ne w i n vesti gat ors.  
5. 4  
S u bject Dis p ositi o n  
T he dis p ositi o n of all s u bjects e nr olle d i n t he st u d y will be descri be d i n ta bles a n d 
dia gra ms , i ncl u di n g n u m bers scree ne d, tr eate d a n d assesse d at eac h s c he d ule d 
f oll o w-u p i nter val.  R oll -i n s u bjects will be assesse d se paratel y as part of t he 
lear ni n g c ur ve a n al ysis. S u bjects w h o d o n ot c o m plete t he st u d y will be e n u merate d 
a n d t he reas o n(s) f or t heir disc o nti n uati o n will be descri be d.  
5. 5  
I m p ut ati o n f or Missi n g D at a 
I m p utati o ns f or missi n g data i n (e. g., wit h dr a w n s u bjects, l oss t o f oll o w -u p, missi n g 
data) will n ot be perf or m e d .  A nal yses will be perf or me d wit h all a vaila ble data 
o nl y.  
5. 6  
P o p ul ati o ns f or  A n al ysis  
E nr olle d P o p ulati o n : all s u bjects w h o pr o vi de t heir i nf or me d c o nse nt. 
Safet y S u bjects : all e nr olle d s u bjects w h o be gi n  t h e I n de x Pr oce d ure. 
I nte nt t o Tr eat S u bjects: all safet y s u bjects w h o u n der g o o ne or m ore a blati o n s at 
the I n d e x Pr oce d ure usi n g t he st u d y de vice . 
Per Pr ot oc ol S u bjects : I nte nt-t o-treat s u bjects f or w h o m t he I n de x Pr oce d ure is 
c o m plete d wit h o ut i nterferi n g i n vesti gati o nal de vice defi cie nc y or malf u ncti o n  a n d 
w h o d o n ot recei ve a n y a blati o ns usi n g a n o nst u d y de vice.  
R oll I n S u bjects : U p t o t he first 2 i nte nt -t o-treat s u bjects per i n vesti gati o nal site  f or 
w h o m t he I n de x Pr oce d ure is c o m plete d wit h o ut i nterferi n g i n vesti gati o nal de vice 
deficie nc y or malf u nct i o n a n d w h o d o n ot recei ve a n y a blati o ns usi n g a n o nst u d y 
de vice.  Safet y a n d effecti ve ness res ults f or t hes e patie nts will be f ull y re p orte d, b ut 
n ot i ncl u de d i n effecti ve ness e n d p oi nt calc ulati o ns.  
Reas o ns f or e x cl usi o n fr o m t he p o p ulati o n s will be gi ve n , a n d a s u m mar y of 
a d verse e ve nts f or t hese s u bjects, if a n y, will be pr o vi de d.  
5. 7  
Fi n al Cli nic al Re p ort  
A fi nal cli nical re p ort  i ncl u di n g t hese a nal yses will be pre pare d at t he c o ncl usi o n of 
t he st u d y or at s uc h ti me as t he st u d y ma y be pre m at urel y ter mi nate d .  C o pi es of t he 
fi nal re p ort will be pr o vi de d t o t he i n vesti gat or a n d t heir E C a n d t o t he C A  as 
a p plica ble.  
 
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 5 1  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
6.  O utc o me Me as ures  
6. 1  
Pri m ar y  S afet y E n d p oi nt  
T he pri mar y safet y e n d p oi nt f or t his st u d y is  t he C o m p osite Safet y E n d p oi nt ( C S E) 
defi ne d as t he i n ci de nce of t he f oll o wi n g seri o us a d verse e v e nts ( S A Es) w hic h are 
de vice - or pr oce d ure -rel ate d, as a dj u dicate d b y t h e C E D M C base d o n t he 
defi niti o ns c o ntai ne d  i n t he C o m p osite Safet y E n d p oi nt Defi niti o ns  Ta ble.   
Earl y o nset ( wit hi n 7  da ys of a n  i n de x or pr ot o c ol -s pecifie d rea blati o n pr o ce d ure) 
•  Deat h  
•  M y ocar dial i nfarcti o n  
•  Persiste nt dia p hra g matic paral ysis  
•  Str o ke  
•  T ra nsie nt isc he mic attac k  
•  Peri p heral or or ga n t hr o m b oe m b olis m  
•  Pericar di al eff usi o n, he m orr ha ge or  ta m p o na de 
•  Vasc ular access c o m plicati o ns  
•  H os pitalizati o n   
•  Heart bl oc k  
Late o nset (a n y ti me d uri n g f oll o w -u p)  
•  P ul m o nar y vei n ste n osis  
•  Atri o -es o p ha g eal fist ula 
* E xcl u des h os pitalizati o n (i nitial or pr ol o n ge d) d ue t o arr h yt h mia ( A F/ Atrial 
Fl utter/ Atrial Tac h ycar dia) rec urre nce or d ue t o n o n -e mer g e nt  car di o v ersi o n 
( p har mac ol o gical or el ectrical). E xcl u d es visits t o h os pital -ass ociate d 
o ut patie nt facilities s uc h as cli nics or  e mer ge nc y war ds.  
 
T a ble 4 . C o m p osite  S afet y E n d p oi nt Defi niti o ns  
 
A d verse E ve nt  
Descri pti o n/ Criteri a  
Deat h  
Deat h  
M y ocar dial i nfarcti o n *  
Cli nical e vi de nce of ac ute m y ocar dial isc he mia wit h detecti o n 
of a rise a n d/ or fall of c T n (car diac tr o p o ni n) val ues wit h at least 
1 val ue a b o ve t he 9 9 t h perce ntile U R L ( u p per refere nce li mit) 
a n d at least o ne of t he f oll o wi n g:  
•  
S y m pt o ms of m y ocar dial isc he mia  
•  
Ne w isc he mic E C G c ha n ges  
•  
De vel o p me nt of pat h ol o gical Q wa ves  
•  
I ma gi n g e vi de nce of ne w l o ss of via ble m y ocar di u m or 
ne w re gi o nal wall m oti o n a b n or malit y i n a patter n 
c o nsiste nt wit h a n isc he mic eti ol o g y  
•  
I de ntificati o n of a c or o nar y t hr o m b us b y a n gi o gra p h y or 
a ut o ps y 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 5 2  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
A d verse E ve nt  
Descri pti o n/ Criteri a  
Persiste nt dia p hra g matic 
paral ysis  
Dia p hra g matic paral ysis : C ha n ge fr o m baseli ne i n t he ele vati o n 
of a he mi dia p hra g m  as de m o nstrate d ra di o gra p hicall y  (c hest 
X -ra y or fl u or osc o p y) b y ele vati o n of t he dia p hra g m a b o ve 
t he n or mal ra n ge b ut n ot d ue t o a p ul m o nar y pr ocess s uc h as 
atelectasis  or ple ural disease . 
Persist e nt: n ot res ol ve d by c o m pleti o n of last st u d y f oll o w-u p 
visit.  
Str o ke  
A n  ac ute s y m pt o matic e pis o de of ne ur ol o gical d ysf u ncti o n 
attri b ute d t o a vasc ular ca use (isc he mia or he m orr ha ge) i n w hic h 
s y m pt o ms last m ore t ha n 2 4 h o urs, or if s y m pt o ms last less t ha n 
2 4 h o urs, a brai n i ma gi n g st u d y de m o nstrates i nfarcti o n.   
T ra nsie nt isc he mic attac k 
A n ac ute e pis o de of te m p orar y ( < 2 4 h o u rs) a n d f ocal l oss of 
cere bral f u ncti o n of vasc ular ( occl usi ve) ori gi n.  
Peri p heral or or ga n 
t hr o m b oe m b olis m 
A car diac t hr o m b us t hat occl u des a m ore distal arterial site. 
C uta ne o us petec hiae are e xcl u de d fr o m t his defi niti o n. 
Pericar dial eff usi o n, 
he m orr ha ge or  ta m p o na de 
T he de vel o p me nt of a si g nifica nt pericar dial he m orr ha ge, 
eff usi o n or ta m p o na de wit hi n 7  da ys of u n der g oi n g a 
pr ot oc ol -s pecifie d a blati o n/rea blati o n pr oce d ure.  
Si g nifica nt : a n e ve nt t hat  res ults i n he m o d y na mic c o m pr o mise 
(e. g. s yst olic B P < 8 0 m m H g) or re q uires pericar di oce ntesis 
or s ur gical drai na ge. 
Vasc ular access 
c o m plicati o ns 
Vasc ular access c o m plicati o n (e. g. gr oi n he mat o ma, A V fist ula, 
pse u d oa ne ur ys m) re q uiri n g si g nifica nt i nter ve nti o n (e. g. 
s ur gical re pair, bl o o d tra nsf usi o n or t hr o m bi n i njecti o n). 
H os pitalizati o n  
I ncl u des a n y h os pitalizati o n , or pr ol o n gati o n of a n e xisti n g 
h os pitalizati o n, f or a relate d a d verse e ve nt.  
E xcl u des a h os pitalizati o n w hic h is necessitate d  s olel y d ue t o : 
1.  T he rec urre nce of  arr h yt h mia ( A F/ atrial fl utter/atrial 
tac h ycar dia) rec urre nce, 
2.  N o n -ur ge nt  car di o versi o n ( p har mac ol o gical or 
electrical), or 
3.  A dia g n ostic pr oce d ure.  
He art bl oc k  
I m pair me nt of A V c o n d ucti o n t hat is relate d t o a pr ot oc ol-
s pecifie d car diac a blati o n pr oce d ure a n d w hic h re q uires 
per ma ne nt paci n g.  
P ul m o nar y vei n ( P V) 
ste n osis  
> 7 0 % dia meter re d ucti o n of p ul m o nar y vei n fr o m baseli n e 
C T/ M R A sca n.  
Atri o -es o p ha geal fist ula  
De m o nstrati o n of a fist ul o us c o n necti o n bet wee n t he atri u m a n d 
t he l u me n of t he es o p ha g us b y ra di o gra p hic, e n d osc o pic or 
p ost m orte m  e xa mi nati o n 
*  T h y gese n et al, F o urt h u ni versal defi niti o n of m y ocar dial i nfarcti o n, Circ ulati o n, N o ve m ber 2 0 1 8, 
accesse d o nli ne at htt ps:// w w w.a haj o ur nals. or g/ d oi/ p df/ 1 0. 1 1 6 1/ CI R. 0 0 0 0 0 0 0 0 0 0 0 0 0 6 1 7 o n J ul y 3 1, 
2 0 1 9.  
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 5 3  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
6. 2  
A d diti o n al  S afet y A n al yses  
T he pr o p orti o n of s u bjects : 
1.  Wit h a n y a d vers e e v e nt i n t he C o m p osite Safet y E n d p oi nt defi niti o ns ta ble, 
w het her or n ot a dj u dicate d as a n S A E  
2.  Wit h  a de vice - or pr o ce d ure -relate d S A E 
3.  Wit h a de vice - or pr o ce d ure -relate d str o ke or TI A 
4.  Wit h a pre -p ost cra nial M RI c h a n ge ( brai n i ma gi n g s u b p o p ulati o n)  
5.  R e q uiri n g  car di o versi o n  
6.  R e q uiri n g  a n arr h yt h mia -relate d h os pitalizati o n 
Lear ni n g c ur ve a n al ysis . 
6. 3  
Pri m ar y Effecti v e ness  E n d p oi nt  
T he pr o p orti o n of s u bjects wit h:  
•  Ac ute Pr oce d ural S uccess, A N D  
•  T hera p e utic S uccess , d efi ne d as free d o m fr o m: 
o  P ost  bla n ki n g peri o d  t hr o u g h assess me nt: occ urre n ce of A F, A F L or 
A T, or a blati o n f or A F/ A F L/ A T usi n g t he st u d y de vice  
o  At a n y ti me: a blati o n f or A F/ A F L/ A T wit h a n o nst u d y de vice  
T hera p e utic s uccess will be assesse d b et wee n  Da y 9 1  an d t he 1 2 m o nt h ± 4 wee k 
f ollo w -u p visit . 
6. 4  
A d diti o n al  Effecti ve ness  A n al yses  
1.  Ac ute Pr oce d ural S uccess, defi ne d as t he p erc ut a n e o us e n d ocar dial creati o n of 
a n electri call y is olati n g set of lesi o ns ar o u n d t he ostia of p ul m o nar y vei ns 
( P V) d uri n g t he i n de x pr oce d ure, as cli nicall y ass esse d b y e ntra nce a n d/ or e xit 
bl oc k perf or m e d ≥ 2 0 mi n utes after t he l ast P VI l esi o n is ma de o n a per 
patie nt basis.  
2.  T he pri mar y effecti ve ness e n d p oi nt f or s u bjects n ot o n A F Ds bet w ee n Da y 
1 0 5 a n d t he 1 2 m o nt h f oll o w -u p visit.  
3.  First pass is o lati o n (i n de x pr oce d ure) c o nsisti n g of Ac ute Pr oce d ural S uccess 
after a si n gle pla n ne d set of lesi o ns i n eac h atte m pt e d P V  
4.  T he pr o p orti o n  of s u bjects wit h earl y rec urre nce of atrial fi brillati o n ( E R A F) 
b y 9 0 da ys after t he i nitial st u d y a blati o n  
5.  T he pr o p orti o n of atte m pte d s u bjects t hat ac hie ve Ac ute  C TI S uccess , defi n e d 
as t he creati o n of bi -directi o nal electrical bl oc k acr oss t he ca v o-tric us pi d 
ist h m us usi n g t he i n vesti gati o nal de vices. 
6.  Lear ni n g c ur ve a n al ysis  
7.  Rate of a n y rea blati o n t hr o u g h 1 2 m o nt hs of f oll o w -u p  
6. 5  
Pr oce d ur al Assess me nts  
1.  Assess me nts of d urati o n f or pr oce d ure c o m p o ne nts  
a. Pr oce d ure ti me (i nitiati o n of ve n o us access t o ve n o us ac cess cl os ure) 
b.  D well ti me (s u m of cat heter e ntr y -t o-e xit d urati o ns) 
c. T otal a blati o n ti me (first a blati o n t o last a blati o n)  
d.  Fl u or osc o p y ti me (t otal d urati o n of e x p os ure)  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 5 4  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
2.  C haracterizati o n of lesi o n sets : 
a. P VI a blati o ns  
b.  E xtra -P V a blati o ns, e x cl u di n g C TI a blati o n s 
c. C TI a bl ati o ns  
d.  A n o mal o us P V a blati o ns  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 5 5  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
7.  A d verse E ve nts , De vice Effects, M alf u ncti o ns a n d Deficie ncies 
7. 1  
A d verse E ve nt s 
A n A d verse E ve nt  ( A E) is an y  u nt o war d me dical occ urre nce, u ni nte n de d disease or 
i nj ur y, or u nt o war d cli nical si g ns (i ncl u di n g a b n or mal la b orat or y fi n di n gs) i n 
s u bjects, users or ot her pers o ns, w het her or n ot rel ate d t o t he i n vesti gati o nal 
me dical de vic e. 
N O T E 1:  
T his defi niti o n i ncl u des e ve nts relate d t o t he i n vesti gati o nal me dical de vice 
or t he c o m parat or.  
N O T E 2:   T his defi niti o n i ncl u des e ve nts relate d t o t he pr oce d ures i n v ol ve d.  
N O T E 3:   F or users or ot her pers o ns, t his defi niti o n is restricte d t o e ve nts relate d t o 
i n vesti gati o nal me dical de vices.  
N O T E 4 : 
T his defi niti o n e xcl u des me dical c o n diti o ns, fi n di n gs or a b n or malities 
prese nt at t he ti me of e nr oll me nt, w hic h are defi ne d as pre -e xisti n g 
c o n diti o ns. Pre -e xisti n g c o n diti o ns will n ot be i ncl u de d i n t he a d verse 
e ve nt dataset. H o we ver, a w orse ni n g of a pre -e xisti n g c o n diti o n d uri n g t he 
st u d y d oes c o nstit ute a n a d verse e ve nt. 
7. 2  
Seri o us A d verse E ve nt s 
A Seri o us A d verse E ve nt  ( S A E) is a n a d verse e v e nt t hat le d t o: 
•  D eat h,  
•  
S eri o us  deteri orati o n i n t he healt h of t he s u bject, t hat eit her res ulte d i n : 
o  a life-t hreate ni n g ill ness or i nj ur y, or 
o  a per ma n e nt i m pair me nt of a b o d y str uct ur e or a b o d y f u ncti o n, or  
o  i n-patie nt or pr ol o n ge d h os pitalizati o n, or  
o  me dical or s ur gical i nter ve nti o n t o  pre ve nt life -t hreate ni n g ill ness or 
i nj ur y or per ma ne nt i m pair me nt t o a b o d y str uct ur e or a b o d y f u n cti o n. 
•  
F etal distress, f etal deat h or a c o n ge nital a b n or malit y or birt h defect . 
N O T E  1 : 
Pla n ne d h os pitalizati o n f or a pre -e xisti n g c o n diti o n, or a pr oce d ur e 
re q uire d b y t he CI P, wit h o ut seri o us deteri orati o n i n healt h, is n ot 
c o nsi dere d a seri o us a d verse e ve nt.   
N O T E 2:  
“ Life -t hreate ni n g” mea ns t hat t he st u d y s u bject was at a s u bsta ntial a n d i m me diate 
ris k of d yi n g d ue t o t hat a d verse e ve nt as it occ urre d.  “ Life t hreate ni n g” a d verse 
e v e nts d o n ot i ncl u de a n a d verse e ve nt t hat ha d it occ urre d i n a m ore se vere f or m, 
mi g ht  ha v e c a use d deat h. 
N O T E 3:  
“ H os pitalizati o n” is a p h ysicia n -or dere d i n patie nt h os pital sta y fr o m o ne cale n dar 
da y t o t he ne xt or l o n ger.  H os pitalizati o n d oes n ot i ncl u de a n o ut patie nt facilit y 
visit or E R visit.  
N O T E 4:  
T he “ pr ol o n gati o n ” is relate d t o t he a d verse e ve nt, e xcl u des dela ys waiti n g f or 
dia g n ostic res ults , is me dicall y necessar y a n d e xte n ds t he h os pital sta y b y at least 
o ne cale n dar da y.  
N O T E 5:  
“Im pair me nt” is defi ne d as a s u bsta ntial disr u pti o n of a pers o n’s a bilit y t o c o n d uc t 
n or mal life f u ncti o ns.  
N O T E 6:  
“ Me dical or s ur gical i nter ve nti o n” i n dicates a pr oce d ure or t hera p y wit h 
si g nifica nt n o vel ris k, dela y or s u bject disc o mf ort, t hat res ults fr o m t he a d verse 
e v e nt. “ M e dical or s ur gical i nter ve nti o n” d oes n ot i ncl u de oral me d icati o n, 
n o ni n vasi ve dia g n ostic testi n g or bl o o d testi n g, r o uti ne i ntra ve n o us fl ui ds or t he 
a d mi nistrati o n of a nti bi otics . 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 5 6  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
 
7. 3  
De vice Effects  
7. 3. 1 
A d verse D e vice Effect s 
A n A d verse De vic e Effect  ( A D E) is a n ad verse  e ve nt relate d t o t he us e of a n 
i n vesti gati o nal medica l de vice 
N O T E 1:  T his defi niti o n i ncl u des a d verse e ve nts res ulti n g fr o m i ns ufficie nt or 
i na de q uate i nstr ucti o ns f or use, de pl o y me nt, i m pla ntati o n, i nstallati o n, or 
o perati o n, or a n y malf u ncti o n of t he i n vesti gati o nal me dical de vice.  
N O T E 2:  
T his defi n iti o n i ncl u des a n y e ve nt res ulti n g fr o m use err or or fr o m 
i nte nti o nal mis use of t he i n vesti gati o nal me dical de vice. 
N O T E 3:  
“ Relate d t o t he uses of a n i n vesti gati o nal me dical de vice” s hall be defi ne d 
f or t his pr ot oc ol as a deter mi nati o n t hat t he effects were  pr o ba bl y or 
defi nitel y relate d t o a n i n vesti gati o nal de vice.  
7. 3. 2  Seri o us A d verse De vic e Effect s 
A Seri o us A d verse De vice Effe ct (S A D E ) is a n ad verse  de vi ce  effect ( A D E) t hat 
has res ulte d i n a n y of t h e c o nse q ue nces c h aracteristic of a S eri o us A d verse E ve nt . 
( S A E). 
7. 3. 3  
U n a ntici p ate d Seri o us A d verse De vice Effect s 
A n U na ntici pate d Seri o us A d verse De vice Effect ( U S A D E ) is a seri o us  a d verse 
de vice effect w hic h b y its nat ure, i nci de n ce, se v erit y or o utc o me has n ot bee n 
i de ntifie d i n t he c urre nt versi o n of t he ris k a n al ysis re p ort as e m b o die d i n Secti o n 
4. 1 of t his CI P . 
N O T E  1 : 
A ntici pate d seri o us a d verse de vice effect ( A S A D E) is a n effect w hic h b y 
its nat ure, i nci de nce, se verit y or o utc o me has bee n i de ntifie d i n t he ris k 
a nal ysis re p ort. 
N O T E 2:  
 If a n S A E is deter mi ne d t o be pr o ba bl y or defi nitel y relate d t o t he de vice 
a n d has n ot bee n pre vi o usl y a ntici pate d, t he cli nical fi n di n g w o ul d be 
classifie d as a n u na ntici pate d seri o us a d verse de vice effect ( U S A D E).  
7. 4  
De vice D eficie nc i es 
A De vice Defici e nc y  is a n ina de q uac y  of a n i n vesti gati o nal me dical de vice relate d 
t o its i de ntit y, q ualit y, d ura bilit y, relia bilit y, safet y or perf or ma nce. T his ma y 
i ncl u de malf u ncti o ns, use err or, or i na de q uac y i n t he i nf or mati o n s u p plie d b y t he 
ma n ufact ur er.  
7. 5  
Use Err or s 
A “Use Err or ” is a n act or o missi o n of a n act t hat r es ults i n a differe nt me di cal 
de vice res p o nse t ha n i nte n de d b y t he ma n ufact urer or e x pecte d b y t he user  
N O T E 1:  
Use err or i ncl u des sli ps, la pses, a n d mista kes.  
N O T E 2:  
A n u ne x pecte d p h ysi ol o gical res p o nse of t he s u bject d oes  n ot i n itself 
c o nstit ute a use err or.  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 5 7  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
7. 6  
M alf u ncti o n s 
A Malf u ncti o n  is a fail ure of a n i n ves ti gati o nal m e dical de vice t o perf or m i n 
acc or da nce wit h its desi g n s pecificati o ns a n d i nte n de d p ur p ose w he n use d i n 
acc or da nce wit h t he i nstr ucti o ns f or use or t he s u bject CI P.  
7. 7  
C a us alit y Rel ati o ns hi p  
T he  i n vesti gat or will assess t he ca usalit y of all a d verse e v e nts i n relati o n t o t he 
i n vesti gati o nal de vice or a n y ot her st u d y-relate d pr oce d ures acc or di n g t o fi ve 
differe nt le v els of ca usalit y:  
1) N ot relate d : r elati o ns hi p t o t he de vice or pr o ce d ures ca n b e e x cl u de d w h e n: 
•  
t he e ve nt is n ot a k n o w n si de effect of t he pr o d u ct cate g or y t he de vice 
bel o n gs t o or of si milar de vices a n d pr oce d ures;  
•  
t he e ve nt has n o te m p or al relati o ns hi p wit h t he use of t he i n vesti gati o n al 
de vice or t he pr oce d ures;  
•  
t he seri o us e ve nt d oes n ot f oll o w a k n o w n res p o ns e patter n t o t he me dical 
de vice (if t h e res p o nse patter n is pre vi o usl y k n o w n) a n d is bi ol o gicall y 
i m pla usi ble; 
•  
t he disc o nti n uati o n of me dical de vice a p plicati o n or t he re d u cti o n of t he 
le vel of acti vati o n/e x p os ure - w he n cli nicall y feasi ble –  a n d rei ntr o d ucti o n 
of its use ( or i ncrease of t he le vel of acti vati o n/e x p os ure), d o n ot i m pact o n 
t he seri o us e ve nt; 
•  
t he e ve nt i n v ol ves a b o d y -site or a n or ga n n ot e x pecte d t o be affecte d b y t he 
de vice or pr oce d ure;  
•  
t he seri o us e ve nt ca n be attri b ute d t o a n ot her ca us e (e. g. a n u n d erl yi n g or 
c o nc urre nt ill ness/ cli nical c o n diti o n, a n effect of a n ot her de vice, dr u g, 
treat me nt or ot her ris k fact ors); 
•  
har ms t o t he s u bject are n ot clearl y d ue t o us e err or;  
•  
I n or der t o est a blis h t he n o n-relate d n ess, n ot all t he criteri a liste d a b o ve 
mi g ht be met at t he sa me ti me, de pe n di n g o n t he t y pe of de vice/ pr oce d ures 
a n d t he seri o us e v e nt.  
2) U nli kel y : t he relati o ns hi p wit h t he use of t he de vice see ms n ot rel e va nt a n d/ or    
t he e ve nt c a n be reas o na bl y e x plai ne d b y a n ot her ca use, b ut a d diti o nal i nf or mati o n 
ma y be o btai ne d.  
3) P ossi ble : t he relati o ns hi p wit h t he use of t he i n vesti gati o nal de vice is w ea k b ut 
ca n n ot be r ule d o ut c o m pletel y. Alter nati ve ca uses are als o p ossi ble (e. g. a n 
u n derl yi n g or c o nc urre nt ill ness/ cli nical c o n diti o n or/a n d a n effect of a n ot h er 
de vice, dr u g or treat me nt). Cases were relate d ness ca n n ot be ass esse d or n o  
i nf or mati o n has bee n o bt ai ne d s h o ul d als o be classifie d as p ossi ble. 
4) Pr o ba ble : t he rel ati o ns hi p wit h t he use of t he i n vesti gati o nal de vice see ms 
rele va nt a n d/ or t he e ve nt ca n n ot reas o na bl y ha ve e x plai ne d b y a n ot her ca us e, b ut 
a d diti o nal i nf or mati o n ma y  be o btai ne d.  
5) Ca usal relati o ns hi p : t he seri o us e ve nt is ass o ciate d wit h t he i n vesti gati o nal 
de vice or wit h pr oce d ures be y o n d reas o n a ble d o u bt w he n:  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 5 8  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
•  
t he e ve nt is a k n o w n si de effect of t he pr o d u ct cat e g or y t he de vice bel o n gs 
t o or of si milar de vices a n d pr oce d ures;  
•  
t he e ve nt has a t e m p oral relati o ns hi p wit h i n vesti gati o nal de vice 
use/a p plicati o n or pr oce d ures;  
•  
t he e ve nt i n v ol ves a b o d y-site or or ga n t hat 
•  
t he i n vesti gati o nal de vice or pr oce d ures are a p plie d t o; 
•  
t he i n vesti gati o nal de vice or pr oce d ures ha v e a n effect o n;  
•  
t he seri o us e ve nt f oll o ws a k n o w n res p o ns e patter n t o t he me dical de vice (if 
t he res p o nse p atter n is pre vi o usl y k n o w n); 
•  
t he disc o nti n uati o n of me dical de vice a p plicati o n ( or re d ucti o n of t he l e vel 
of acti vati o n/e x p os ure) a n d rei ntr o d ucti o n o f its use ( or i ncrease of t he le vel 
of acti vati o n/e x p os ure), i m pact o n t he  seri o us e v e nt ( w he n cli nicall y 
feasi ble); 
•  
ot her p ossi ble ca uses (e. g. a n u n derl yi n g or c o n c urre nt ill ness/ cli nical 
c o n diti o n or/a n d a n effect of a n ot her de vi ce, dr u g or treat me nt) h a ve bee n 
a de q uatel y r ul e d o ut;  
•  
har m t o t he s u bject is d ue t o err or i n us e ; 
•  
I n or der t o est a blis h t he relate d ness, n ot all t he criteria liste d a b o ve mi g ht b e 
met at t he sa me ti me, de p e n di n g o n t he t y pe of de vice/ pr oce d ures a n d t h e 
seri o us e ve nt. 
F or t he d eter mi nati o n of de vice a n d pr oce d ure rel ate d ness f or t his trial’s safet y 
o utc o me meas ur es, ca us al a n d pr o ba ble relati o ns hi ps will be dee me d “relate d” a n d 
n ot relate d, u nli kel y a n d p ossi ble relati o ns hi ps will be dee me d “ u nrelat e d.”  A n 
a nal ysis of a d verse e v e nt cate g ories b y all fi ve t y p es of relati o ns hi ps will als o be 
perf or me d.  
7. 8  
Re p orti n g  
A Es a n d S A Es:  
All A Es, i ncl u di n g all S A Es, will be m o nit ore d fr o m t he ti me of e nr oll me nt t hr o u g h 
disc har ge f or t hi s st u d y.  All A Es m ust be d oc u me nte d  i n t he patie nt c hart  a n d 
rec or de d i n t he a p pr o priate C R F  or e C R F .  A descri pti o n of t he e ve nt, i ncl u di n g t he 
start date, res ol uti o n date, acti o n ta ke n a n d t h e o utc o me s hall be pr o vi de d al o n g 
wit h t he I n v esti gat or’s assess me nt of t he seri o us ness of t he e ve nt a n d the 
relati o ns hi p bet wee n t h e A E a n d t he st u d y de vice s a n d/ or pr oce d ures. 
All A Es s h o ul d be f oll o we d u ntil t he e ve nt is res ol ve d , j u d ge d t o be c hr o ni call y 
sta ble or 1 2 m o nt h st u d y f oll o w -u p has bee n c o m plete d .  T he i n vesti gati o nal site 
will pr o vi de rele va nt f oll o w-u p i nf or mati o n t o t he S p o ns or or desi g nee u p o n 
re q uest. 
T he i n vesti gat or s h all als o re p ort t o t he S p o ns or or its desi g ne e a n y De vice 
Deficie n cies or Malf u n cti o ns t hat di d n ot b ut mi g ht ha ve l e d t o a S A E if s uc h a n 
e ve nt were t o rec ur . 
T he i n vesti gat or s h all n otif y t he S p o ns or  a n d t he desi g nate d C R O i m me di atel y a n d 
n ot l ater t h a n 2 4 h o urs  after t he In v esti gat or  has bec o me a ware of a  S A E or D e vice 
D eficie nc y / M alf u ncti o n t h at mi g ht h a ve le d t o a S A E.  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 5 9  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
T he I n v esti gat or s hall re p ort t he S A E or De vice Deficie nc y / Malf u ncti o n o n t he 
a p pr o priate C R F   
S h o ul d mail c orres p o n de nce be n ecess ar y, d oc u m e nts ca n be s e nt t o t he f oll o wi n g:  
C R O:  
 
Me d Pass I nt er nati o nal S A S   
Fa x :    
+ 3 3 ( 0) 1 4 0 5 3 8 1 1 1  
S p o ns or : 
F A R A P U L S E , I nc. 
E mail:   
cli nical@ fara p ulse.c o m  
 
 
 
C o ntact:  
Mr . C hrist o p her Sc h nei d er  
Ret ur n of S u bject De vice:  
I n all cases, a n d w he n e ver p ossi ble t he de vice i n v ol ve d i n t he A E, S A E, De vice 
Deficie n c y / M alf u ncti o n as descri be d a b o ve is t o be ret ur n e d t o t he S p o ns or or 
S p o ns or’s desi g nee f or a nal ysis a n d i n vesti gati o n, as a p pr o priat e . T he St u d y 
C o or di nat or s hall c o ntact t he S p o ns or f or i nstr ucti o ns o n ret ur ni n g t he de vi ce.  
De vice D eficie nci es a n d M alf u ncti o ns:  
All De vice D eficie n cies / Malf u ncti o ns t hat di d n ot c o ntri b ute a n d w o ul d n ot li kel y 
c o ntri b ute t o a S A E, s hall be d oc u me nte d o n t he De vice Deficie nc y / Malf u ncti o n 
C R F a n d s u b mitte d t o t he S p o ns or wit hi n 7 d a ys  after t he o bs er ve d De vice 
Deficie n c y / Malf u ncti o n.  T he S p o ns or’s Q ua lit y Ass ura nce f u ncti o n s hall e ns ure 
a n assess me nt is c o m plet e d f or eac h re p orte d De vi ce Deficie nc y / M alf u ncti o n. 
S uc h i nf or mati o n s hall be pr o vi de d i n t he fi nal cli nical re p ort.  
De pe n di n g o n t he l oc al r e q uire me nts or f oll o wi n g a gree m e nt bet wee n b ot h part ies, 
t he S p o ns or , its desi g nate d re pres e ntati ve ( C R O) or t he P ri nci pal In vesti gat or will 
be res p o nsi ble f or perf or mi n g safet y re p orti n g t o t he Et hics C o m mittee acc or di n g t o 
t he rele va nt l ocal re g ulat or y re q uire m e nts.  
T he S p o ns or or desi g nate d re pres e ntati ve ( C R O) will be res p o nsi ble f or re p orti n g t o 
t he Nati o nal C o m pete nt A ut h orit y acc or di n g t o n ati o nal re q uire me nts i n acc or da n ce 
wit h M E D D E V 2. 7/ 3.  
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 6 0  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
8.  M o nit ori n g  
Cli nical m o nit ors, q ualifie d b y trai ni n g a n d e x p eri e nce, will be res p o nsi ble f or 
m o nit ori n g a n d o v erseei n g t he c o n d uct of t he st u d y i n acc or da nce wit h t he St u d y 
M o nit ori n g Pla n .   
T he cli nical m o nit ors will e val uate c o m plia nce wit h t he pr ot oc ol, a n y s pecific 
rec o m me n dati o ns ma d e b y t he site’s E C a n d t he si g ne d I n v esti gat or A gree me nt.  
P h o ne c o ntacts a n d site visits will be c o n d ucte d t o e ns ure t hat t he pr ot o c ol is bei n g 
f oll o we d a n d t hat a n y pr ot oc ol de viati o ns are pr o perl y d oc u me nte d.  Cli nical 
m o nit ori n g will i ncl u de a verificati o n t hat t he I C F was pr o perl y o btai ne d f or all 
e nr olle d st u d y pa rtici pa nts, a re vie w of cli nical r ec or ds f or acc urac y a n d 
c o m plete ness, res ol uti o n of missi n g or i nc o nsiste nt res ults a n d a re vi e w of s o urce 
d oc u me nts .  T he cli nical m o nit or will verif y t hat t he C R Fs a gree wit h t he s o urce 
d oc u me ntati o n a n d ot her rec or ds .  T h e In vesti gat or will ma ke a vaila ble t o t he 
cli nical m o nit or f or re vie w all I C Fs, all c o m plete d C R Fs, s o urce d oc u m e ntati o n a n d 
ot her rele v a nt rec or ds f or all e nr olle d s u bjects at t he site .   
If a deficie nc y is n ote d d uri n g a n o n-site m o n it ori n g visit or at  a n y ot her ti me 
d uri n g  t he st u d y, t he cli nical m o nit or is re q uire d t o disc uss t he sit uati o n wit h t he 
In v esti gat or a n d t he S p o ns or t o e ns ure c o m plia nce.  
T he S p o ns or or its desi g nate d re prese ntati ve, q ualifie d b y trai ni n g a n d e x p erie nce, 
will be res p o nsi ble f or m o nit ori n g a n d o verseei n g t he c o n d uct of t he st u d y.  T he 
acc urac y of all c ollecte d data will be verifi e d f or:  
•  Eli gi bilit y criteria  
•  Baseli ne c haracteristics  
•  Pri mar y safet y a n d feasi bilit y e n d p oi nts  
•  Sec o n dar y e n d p oi nts  
•  A d verse e ve nts  (i ncl u di n g S A Es) a n d De vice Deficie ncies / 
Malf u ncti o n 
Re p orti n g  
Verific ati o n will utilize  s o urce d oc u m e nts i ncl u di n g, b ut n ot li mite d t o, me dical 
rec or ds, office/ cli nic n otes, pr oce d ure re p orts, la b orat or y res ults, p h ysicia n a n d 
n ursi n g pr o gress n otes .  Verificati o n a n d q ua lit y of data, m o nit ori n g of cli nical 
st u d y pr o gress a n d I n v esti gat or c o m plia nce wit h t he a p pr o ve d pr ot oc ol will be 
c o n d ucte d b y t he S p o ns or or its desi g nate d re pres e ntati ve.  
T he S p o ns or or its desi g nate d re prese ntati ve m ust be all o we d t o visit t he cli nical  
site a n d ha ve dir ect access t o all st u d y rec or ds t hr o u g h o ut t he d urati o n of t he st u d y .  
T he m o nit or will re vie w all s o urce dat a a n d c o m p are t he m t o t he dat a d oc u me nte d 
i n t he C R F s, i n a d diti o n t o perf or mi n g a re vie w of t he Re g ulat or y Site  Bi n der a n d  
assessi n g  de vice acc o u nt a bilit y .  T he I n v esti gat or a n d  / or i nstit uti o n will pr o vi de 
direct access t o s o urce data/ d oc u me nts f or st u d y-relate d m o nit ori n g, a u dits, a n d 
re g ulat or y re vie w a n d i ns pecti o n. 
It is i m p orta nt t hat t he I n vesti gat or a n d ot her rele va n t site pers o n nel, i ncl u di n g t he 
researc h st u d y c o or di nat or, are a vaila ble f or c o ns ultati o n wit h t he cli nical m o nit ors 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 6 1  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
d uri n g t he m o nit ori n g visits a n d t hat s ufficie nt ti me is de v ote d at t he site f or t he 
m o nit ori n g pr ocess.   
A d diti o nall y, tele p h o ne, e mail c o ntact, a n d o nsite visits will be c o n d ucte d o n a 
re g ular b asis wit h t he I n v esti gat or a n d t he site staff t o e ns ure t hat t he pr ot oc ol is 
bei n g f oll o we d a n d t o a d dress a n y iss ues t hat ma y occ ur d uri n g t he st u d y. 
If a deficie nc y is n ote d d uri n g  t he st u d y, t he cli nical m o nit or is re q uire d t o disc uss 
t he sit uati o n wit h t he site a n d t he S p o ns or (if re q uire d) t o sec ure c o m plia nce.  A 
M o nit ori n g Site Visit Re p ort will be iss ue d t o t he I n v esti gat or a n d S p o ns or.  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 6 2  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
9.  St u d y M a n a ge me nt  
T he S p o ns or has o verall res p o nsi bilit y f or t he c o n d uct of t he st u d y acc or di n g t o 
G o o d Cli nical Practice G ui deli nes (I C H E 6 C o ns oli date d G ui da nce t o G o o d 
Cli nical Practice) as well as a n y c o n diti o ns i m p ose d b y l ocal a n d nati o nal 
re g ulat or y a ut h orities.  
F or t he s ubje ct i n vesti gati o n, t he  S p o ns or will ha ve direct r es p o nsi bilities a n d will 
dele gate ot her res p o nsi bilities t o a p pr o priate a n d q ualifie d c o ns ulta nts, c o ntract ors 
a n d/ or C R Os .  T o get her, t he S p o ns or, c o ns ulta nts a n d C R O will e ns ure t hat t he 
st u d y is c o n d ucte d acc or di n g t o t he a p pr o ve d CI P , E C -a p pr o ve d I C F a n d all 
a p plica ble g o ver ni n g re g ulati o ns .  All pers o n nel t o partici pate i n t he c o n d u ct of t his 
cli nical st u d y will be q ualifie d b y e d ucati o n a n d/ or e x peri e nce t o p erf or m t heir 
tas ks. 
9. 1  
  Ke y C o ntri b ut ors  
9. 1. 1 
St u d y S p o ns or  
F A R A P U L S E, I nc.  
3 7 1 5 Ha ve n A v e .  S uite 1 1 0  
Me nl o Par k, C A 9 4 0 2 5, U S A  
P h o ne:  6 1 7 -6 8 6 -7 6 6 1  
E mail:  ksc h nei der @ fara p ulse.c o m 
9. 1. 2  
C R O  
Me d Pass I nt er nati o nal S A S  
9 5 b B o ule var d Pereir e  
7 5 0 1 7 Paris, Fra n ce  
Tel N o: + 3 3 1. 4 2. 1 2. 8 3. 3 0  
9. 1. 3  
Arr h yt h mi a  C ore L a b  
M D T –  Me dical D ata Tra nsfer, s.r. o.  
Za br d o vic ka 2, 6 1 5 0 0 Br n o  
Czec h Re p u blic  
C o ntact: Ver o ni ka B ol k o va  
Tel: + 4 2 0 7 2 5 0 6 9 1 9 5  
i o wa @ m dte k g.cz 
  
9. 2  
Et hic al C o nsi der ati o ns  
It is e x p ecte d t hat all parties will s hare i n t he res p o nsi bilit y f or et hical c o n d uct i n 
acc or da nce wit h t heir res pecti ve r oles i n t he i n vesti gati o n .  T he S p o ns or a n d t he 
I n v esti gat or s hall a v oi d i m pr o per i nfl ue nce or i n d uce me nt of t he s u bject, m o nit or, 
ot her cli nical i n vesti gat or or ot her parties p artici pati n g i n or c o ntri b uti n g t o t he 
cli nical i n vesti gati o n.  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 6 3  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
9. 2. 1 
St u d y  C o n d uct  
T he st u d y will be perf or me d i n acc or da nce wit h t he rele va nt parts of t he C o de of 
Fe deral Re g ulati o ns, I C H G ui deli nes f or G o o d Cli nical Practices, t he E ur o pea n 
Sta n dar d I S O 1 4 1 5 5, t he Declarati o n of Helsi n k i, a n d a n y re gi o n al a n d/ or n ati o nal 
re g ulati o ns.  T he cli nical i n vesti gati o n s hall n ot be gi n u ntil t he re q uire d a p pr o val 
has bee n o btai ne d fr o m t he N ati o nal C A a n d t he l ocal E C .  A n y a d diti o nal 
re q uire me nts i m p ose d b y t he re g ulat or y a ut h orit y or E C s hall be f oll o we d .  T hese 
pri nci ples s hall pre vail o ver i nterests of scie nce a n d s ociet y a n d s hall be 
u n derst o o d, o bser ve d a n d a p plie d at e ver y ste p i n t his cli nical i n vesti gati o n.  
9. 2. 2  Et hics Re vie w  
Bef ore a n y s u bj ect c a n b e e nr olle d i n t his st u d y, t he l ocal or nati o nal E C a n d t he 
C A m ust re vie w a n d a p pr o ve t he CI P a n d t he I C F t o be use d.  A s u bject ca n n ot be 
as ke d t o si g n t he I C F u ntil t he st u d y has bee n f ull y a p pr o ve d b y t he i nstit uti o n’s 
E C a n d b y t he C A, if a p plica ble .  T he S p o ns or or t heir desi g nate d C R O will 
re q uire a c o p y of a n y E C c orres p o n d e nce, as well as t he fi nal E C a p pr o val letter 
a n d t he fi nal E C -a p pr o ve d I C F, a n d a p pr o vals f or t he CI P a n d I C F re visi o ns o n 
a me n d me nts fr o m t he E C . T he S p o ns or or t heir d esi g nate d C R O will kee p all t he 
C A c orres p o n d e nce, as w ell as t he C A a p pr o val letter.  
9. 2. 3  I nf or me d C o nse nt 
S u bjects will n ot  si g n t he I C F u ntil t he st u d y has bee n f ull y a p pr o ve d b y t he 
i nstit uti o n’s Et hics C o m mittee a n d t he S p o ns or or t heir desi g nate d C R O has 
recei v e d a n d re vie we d t he s pecific E C -a p pr o ve d I C F.  W he n t he In vesti gat or has 
deter mi ne d t he eli gi bilit y of a s pecifi c s u bject t o e nter t he st u d y, t he I C F m ust be 
c o m plete d.  T he I C F m ust be rea d a n d u n derst o o d b y t he s u bject, t he s u bject’s 
q uesti o ns a ns were d , a n d t he f or m si g ne d b y t he s u bject bef ore a n y st u d y -relate d 
pr oce d ures ca n b e perf or me d .  All s u bjects are t o recei v e c o pies of t h eir si g ne d 
I C F. 
9. 2. 4  C o ver a ge of E x pe nses  
St u d y partici pa nts will be rei m b urse d f or tra v el c osts relate d t o st u d y h os pital 
visits.  
9. 2. 5  S h ari n g Ne w I nf or m ati o n  
If ne w i nf or mati o n bec o mes a vaila ble t hat ca n si g nifica ntl y affect a s u bject's 
f ut ure healt h a n d me dical care,t h at i nf or mati o n s hall be pr o vi de d t o t he s u bject(s) 
affecte d i n writte n f or m  b y t he i n vesti gat or.  T he s p o ns or will pr o v i de all s uc h 
i nf or mati o n t o all i n vesti gat ors. If rele va nt, all affecte d s u bjects s hall be as ke d t o 
c o nfir m t heir c o nti n ui n g i nf or me d c o nse nt i n writi n g.  
9. 2. 6  C o nfi de nti alit y  
C o nfi de ntialit y of s u bjects will be mai ntai ne d t hr o u g h o ut t he st u d y.  A u ni q ue 
i de ntificati o n c o de will b e assi g ne d t o eac h s u bject partici pati n g i n t his st u d y.  
A n y data t hat ma y be p u blis he d i n a bstracts, scie ntific j o ur nals, or pres e nte d at 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 6 4  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
me dical meeti n gs will refere nce a u ni q ue s u bj ect c o de a n d will n ot re veal t he 
s u bject’s i de ntit y.  T he S p o ns or , C R O , I n v esti gat ors a n d Site pers o n nel will ma ke 
e ver y reas o na bl e eff ort t o pr otect t he c o nfi de ntialit y of all s u bjects partici pati n g i n 
t he st u d y. 
 
9. 3  
I ns ur a nce 
T he S p o ns or will mai ntai n t he a p pr o priat e a n d necessar y i ns ura n ce c o vera g e f or t he 
d urati o n of t he st u d y.  
9. 4  
A u dits a n d I ns pecti o ns  
T he P ri nci pal In vesti gat or will als o all o w re prese ntati ves of t he g o ver ni n g E C,  C A , 
U. S . F o o d a n d Dr u g A d mi nistrati o n , a n d ot her a p plica ble re g ulat or y a ge n cies t o 
i ns pect all st u d y rec or ds, C R Fs, a n d c orres p o n di n g p orti o ns of t he s u bject’s office 
a n d/ or h os pital me dical r ec or ds at r e g ular i nter vals t hr o u g h o ut t he st u d y.  T hese 
i ns pecti o ns are f or t he p ur p ose of verif yi n g ad here nce t o t he CI P , c o m plete ness a n d 
e xact ness of t h e data b ei n g e ntere d o nt o t he C R Fs a n d c o m plia nce wit h re g ulat or y 
a ge nc y re g ulati o ns.  
T he P ri nci pal In vesti gat or will i nf or m t he S p o ns or or t he S p o ns or’s desi g ne e s h o ul d 
t he y be a u dite d or i ns pecte d b y an y re g ulat or y a ge ncies .  T he S p o ns or or t h e 
S p o ns or’s desi g nee will als o i nf or m t he site if t he y are ma de a ware of a pe n di n g 
a u dit or i ns pecti o n b y a re g ulat or y a ge n c y.  
9. 5  
S p o ns or Res p o nsi bilities  
S p o ns or has t he o verall res p o nsi bilit y f or t he st u d y a n d will: 
•  Select q ualifie d I n v esti gat or s, cli nical i n vesti gat ors a n d st u d y sites. 
•  Select q ualifie d m o nit ors . 
•  Pr o vi de t he CI P a n d a n y s u bse q ue nt a me n d me nts . 
•  Pr o vi de a p pr o priate i nf or mati o n a n d I n v estigati o nal s yste m trai ni n g t o t he 
I n v esti gat or a n d st u d y site staff. 
•  E ns ure t hat all de viati o ns fr o m t he CI P are re vie we d wit h t he a p pr o pri ate 
I n v esti gat or(s) a n d re p orte d o n  t he C R Fs a n d t he fi nal cli nical re p ort a n d t hat 
a n y necessar y pre ve ntati ve or c orrecti ve acti o n is ta ke n . 
•  E ns ure t hat all A Es a n d all A D Es are re p ort e d a n d re vie we d wit h t he 
I n v esti gat or(s), a n d w here a p pr o pri ate, t hat all S A Es a n d all S A D Es are 
a p pr o priatel y re p orte d . 
•  E ns ure t hat all De vice Deficie nci es / Malf u ncti o ns are re vie we d b y t h e 
S p o ns or, a n d pr o perl y assesse d a n d i n vesti gate d, as a p pr o priat e.  
•  Pr o m ptl y i nf or m t he I n vesti gat or a n d w here a p plica ble, a n y re g ulat or y 
a ut h orities, if t he st u d y is pre mat urel y ter mi nate d or s us pe n de d a n d t h e reas o n 
f or t he ter mi nati o n or s us pe nsi o n. 
•  E ns ure pr o per de vic e usa ge, u nif or m data c ollecti o n a n d pr ot oc ol c o m plia nce . 
•  Pr o vi de site i nitiati o n trai ni n g t o i ncl u de re vie w of t he F A R A P U L S E A blati o n 
S yste m Pl us  Instr ucti o ns f or Use , t he Cli nical I n v esti gati o n Pla n, C R F 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 6 5  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
i nstr ucti o ns, C R Fs , A E/ S A E/ De vice Defici e nc y re p orti n g a n d re q uire m e nts 
f or o btai ni n g inf or me d c o nse nt . 
•  Pr o vi de t he F A R A P U L S E A blati o n S yste m Pl us  t o t he partici pati n g st u d y 
site, i n q ua ntities t o s u p p ort st u d y acti vities. 
•  C o or di nate o n g oi n g c o m m u nicati o n wit h C R Os, c o ns ulta nts a n d st u d y site t o 
res ol ve a n y pr o ble ms c o ncer ni n g t he pr ot o c ol or data c ollecti o n 
•  E ver y eff ort will be ma d e t o e ns ure c o m plia nce wit h t he pr ot oc ol . 
•  Retai n o w ners hi p of all cli nical data ge nerate d i n t his st u d y a n d c o ntr ol t he 
use of t he data f or p ur p os es of re g ulat or y s u b missi o ns t o C As . 
•  Pr otect s u bject c o nfi de nti alit y . 
•  Pr o vi de R e g ulat or y Site B i n der t o site. 
9. 6  
M o nit or Res p o nsi bilities  
Cli nical m o nit ors, q ualifie d b y trai ni n g a n d e x p eri e nce, will be res p o nsi ble f or 
m o nit ori n g a n d o verseei n g t he c o n d uct of t he st u d y. 
Site I niti ati o n Visit:  S p o ns or pers o n nel a n d / or c li nical m o nit ors will c o n d uct site 
i nitiati o n visits at t he i n vesti gati o nal site t o e ns ure t hat t he P ri nci pal In vesti gat or 
a n d ot her i n vesti gati o nal site pers o n nel i n v ol ve d i n t he c o n d uct of t his i n vesti gati o n 
ha ve recei ve d a n d u n derst o o d t he re q uire me nts a n d c o nte nts of t his C li nical 
In v esti gati o n Pla n , t he I n vesti gat or’s Br oc h ure, t he patie nt I C F, t he C R Fs, C R F 
I nstr u cti o ns, A E/ S A E/ De vice Defi cie nc y re p orti n g  re q uire me nts, a n d t h e 
I nstr u cti o ns f or Use a n d t he Instit uti o n a n d/ or In v esti gat or A gree me nt.  
Site M o nit ori n g:  T he cli nical m o nit ors will c o n d uct r o uti ne o n -site m o nit ori n g 
visits a n d p h o ne calls i n acc or da nce wit h a St u d y M o nit ori n g Pla n t o e val uate 
c o m plia nce wit h t he CI P , a n y s pecific rec o m me n d ati o ns ma de b y t he site’s E C a n d 
t he si g ned I nstit uti o n a n d/ or I n v esti gat or A gree me nt a n d t o e ns ure t hat t he CI P is 
bei n g f oll o we d a n d t hat a n y pr ot oc ol de viati o ns are pr o perl y d o c u me nte d o n t he 
res pecti ve C R F .  Cli nical m o nit ori n g will i ncl u de a verificati o n t hat i nf or me d 
c o nse nt was pr o p erl y o bt ai ne d a n d d oc u m e nte d f or all e nr olle d st u d y partici pa nts, a 
re vie w of cli nical rec or ds a n d C R Fs f or acc urac y a n d c o m plete ness, res ol uti o n of 
missi n g or i nc o nsiste nt res ults a n d a re vie w of s o urce d oc u m e nts.  
Cli nical m o nit ori n g will i ncl u de a re vie w of all a d verse e v e nts , S A Es a n d D e vice 
D eficie n cies / M alf u ncti o ns t o e ns ure t hat all i nf or mati o n has bee n re p orte d t o t he 
S p o ns or, E C a n d re g ulat or y a ut h orities as re q uire d b y  t he Cli nical In v esti gati o nal 
P la n a n d a p plica ble sta n d ar ds a n d la ws. 
T he cli nical m o ni t or will verif y t hat t he C R Fs are c o m plete a n d i n a gree me nt wit h 
t he s o urce d o c u me ntati o n a n d ot her rec or ds.  T h e cli nical m o nit or will e ns ure t hat 
all C R Fs ha ve bee n si g n e d a n d date d b y t he In v esti gat or.  
T he In vesti gat or will ma ke a vaila ble t o t he cli nica l m o nit or f or re vie w all I C Fs, all 
C R Fs, s o urce d oc u m e ntati o n a n d ot her rele va nt rec or ds f or all e nr olle d s u bjects at 
t he site.  It is i m p orta nt t hat t he In vesti gat or a n d ot her rele va nt site pers o n nel are 
a vaila ble f or c o ns ultati o n wit h t he cli nical m o nit o rs d uri n g t he m o nit ori n g visits 
a n d t hat s ufficie nt ti me is de v ote d at t he site f or t h e m o nit ori n g pr ocess.  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 6 6  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
If a deficie nc y is n ote d d uri n g a n o n-site visit or at a n y ot her ti me d uri n g t he c o urse 
of t he st u d y, t he cli nical m o nit or is re q uire d t o disc uss t he sit uati o n wit h t he 
In v esti gat or a n d t he S p o ns or, a n d t o s u bse q ue ntl y m o nit or t he i m ple me ntati o n of 
c orrect i ve acti o ns t hat are re q uir e d t o a d dress t he sit uati o n. 
All m o nit ori n g acti vities will be d oc u me nte d b y t h e cli nical m o nit or i n a 
M o nit ori n g Re p ort a n d will i ncl u de, at a mi ni m u m, t he date, i n vesti gati o nal site 
visite d, na mes of all pers o n nel i n v ol ve d i n t he visit, a listi n g of all d oc u me nts 
re vie we d a n d a s u m mar y of all fi n di n gs, facts, de viati o ns, c o ncl usi o ns a n d 
rec o m me n de d acti o ns t o be ta ke n.  Ke y fi n di n gs will be re vie we d wit h t he cli nical 
i n vesti gat or.  
U p o n c o m pleti o n of t he st u d y, a st u d y cl ose o ut visit will be c o n d ucte d t o e ns ure 
t hat all data c ollecti o n a n d st u d y re q uire me nts are c o m plete. 
9. 7  
I n vesti g at or Res p o nsi bilities 
At a mi ni m u m, t he f oll o wi n g d oc u me nts will be pr o vi de d b y t he i n vesti gati o nal site 
t o t he S p o ns or pri or t o st u d y start (c o nse nt of t he first s u bject): 
•  Si g ne d Cli nical Trial A gree me nts  
•  Si g ne d Fi na ncial Discl os ure F or m  
•  Si g ne d Cli nical I n vesti gati o n Pla n Si g n at ure Pa ge 
•  I n v esti gat or a n d C o-I n v esti gat or’s c urre nt C urric ul u m Vitae 
•  A n y ot her a d diti o nal d oc u me nts as re q uire d b y t h e S p o ns or  
T he I n vesti gat or is r es p o nsi ble f or e ns uri n g t hat t he i n vesti gati o n is c o n d ucte d 
acc or di n g t o all si g ne d a gree me nts, t he CI P , go ver ni n g re g ulati o ns, data pr otecti o n 
re g ulati o ns, me dical de vi ce la ws, t he Declarati o n of Helsi n ki a n d a n y ot her 
c o n diti o ns i m p ose d b y t he rele va nt re g ulat or y a ut h orities .  T he I n vesti gat or is 
res p o nsi ble f or mai ntai ni n g me dical a n d st u d y rec or ds f or e v ery s u bject 
partici pati n g i n t he cli nic al st u d y (i ncl u di n g i nf or mati o n mai ntai ne d electr o nicall y 
s uc h as di gital i ma gi n g).  T he I n vesti gat or will als o mai ntai n ori gi nal s o urce 
d oc u me nts fr o m w hic h st u d y -relate d d ata are deri ve d. 
T he I n vesti gat or(s) s hall be res p o nsi ble f or t he da y t o da y c o n d uct of t he 
i n vesti gati o n as well as f or t he safet y a n d well-b ei n g of t he h u ma n s u bjects 
i n v ol ve d i n t he cli nical i n vesti gati o n. 
T he I n vesti gat or(s) s hall:  
•  Ha ve t he q u alifie d a n d tr ai ne d res o urces t o c o n d u ct t he i n vesti gati o n pr o perl y. 
•  O btai n fr o m t he S p o ns or t he i nf or mati o n w hic h t h e I n vesti gat or(s) j u d ges 
esse ntial a b o ut t he de vice a n d be fa miliar wit h t his i nf or mati o n . 
•  Be well ac q uai nte d wit h t he CI P bef ore si g ni n g t he si g nat ure pa ge . 
•  S u p p ort t he m o nit or, a u dit or, if a p p lica ble, i n t heir acti vities t o verif y 
c o m plia nce wit h t he CI P, t o perf or m s o urce data verificati o n a n d t o c orrect 
t he C R F w here i nc o nsiste ncies or missi n g val ues are i de ntifie d. 
•  Disc uss wit h t he S p o ns or ma na ge me nt a n y q u esti o n of m o dificati o n of t he 
CI P . 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 6 7  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
•  Ma ke s ure t hat t he CI P is f oll o we d b y all res p o nsi ble f or t he c o n d u ct of t he 
st u d y at his/ her i nstit uti o n.  A n y de viati o n s hall be d oc u me nte d a n d re p orte d 
t o t he st u d y S p o ns or a n d C R O. 
•  Ma ke t he necessar y arra n ge me nts t o e ns ure t he pr o per c o n d uct a n d 
c o m pl eti o n of t he i n vesti gati o n . 
•  Ma ke t he necessar y arra n ge me nts f or e mer ge n c y treat me nt, as n ee de d, t o 
pr otect t he healt h a n d welfare of t h e s u bject . 
•  E ns ure t hat a p pr o priate E C a n d C A a p pr o val is o btai ne d pri or t o t he start of 
t he i n vesti gati o n. 
•  I nf or m S p o ns or a b o ut a d verse e v e nts a n d D e vice D eficie ncies / M alf u ncti o ns 
i n a ti mel y ma n ner; d oc u me nt o n a p plica ble C R Fs. 
•  E n dea v or t o e ns ure a n a d e q uate recr uit me nt of s u bjects . 
•  E ns ure t hat t he s u bject h as a de q uat e i nf or mati o n a n d ti me t o pr o vi de i nf or me d 
c o nse nt . 
•  E ns ure t hat i nf or me d c o nse nt is o btai ne d a n d d oc u me nte d  o n t he E C -a p pr o ve d 
I C F. 
•  E ns ure t hat cli nical r ec or ds are cl earl y mar ke d t o i n dicate t hat t he s u bject is 
e nr olle d i n t his st u d y. 
•  Pr o vi de s u bjects wit h well -defi ne d pr oce d ures f or a n y e mer g e nc y sit uati o n 
a n d safe g u ar d t he s u bject’s i nterest .  U n der t hese circ u msta nces, de vi ati o ns 
fr o m t he CI P s hall n ot re q uire t he pri or a p pr o val of t he S p o ns or or t he nati o nal 
a n d l ocal  re g ul at or y a ut h orities.  S uc h de viati o ns s hall n ot be c o nsi dere d as a 
breac h of a gree me nt b ut s hall be d oc u me nte d a n d re p orte d t o S p o ns or . 
•  E ns ure t hat i nf or mati o n w hic h bec o mes a vaila ble as a res ult of t he cli nical 
i n vesti gati o n w hic h ma y be of i m p orta nce t o t he h ealt h of a s u bject a n d t he 
c o nti n uati o n of t he i n vesti gati o n s hall be ma de k n o w n t o t he S p o ns or a n d, if 
perti ne nt t o t he safet y or well -bei n g of t he s u bject, a n d t he pri vate cli nicia n . 
•  I nf or m t he s u bject a n d/ or t he s u bject’s p h ysicia n a b o ut a n y pre mat ure 
ter mi nati o n or s us pe nsi o n of t he i n vesti gati o n wit h a rati o nale f or st u d y 
ter mi nati o n. 
•  Ha ve pri mar y res p o nsi bilit y f or t he acc urac y, le gi bilit y a n d sec urit y of all 
i n vesti gati o n data, d oc u me nts a n d s u bject rec or ds b ot h d uri n g a n d after t h e 
i n vestigati o n . 
•  Si g n eac h s u bject’s C R F, as a p plica ble . 
•  Be res p o nsi ble f or t he s u per visi o n a n d assi g n me nt of d uties at his/ her cli nical 
ce nter.  
•  
E ns ure t hat all i n vesti gati o nal de vices are k e pt i n a sec ure l o cati o n a n d t hat all 
S yste ms are acc o u nte d f or o n t he De v ice Acc o u nta bilit y  F or m ( n u m ber of 
de vices use d, discar de d a n d ret ur ne d t o S p o ns or).  
•  
I n v esti gat or s hall assi g n res p o nsi bilit y of Re g ulat or y Site Bi n der a n d its 
mai nte na nce t o t he Res earc h St u d y C o or di nat or . 
9. 8  
I n vesti g at or Tr ai ni n g 
T he partici pati n g i n vesti ga t or will be trai ne d i n t h e use of t he F A R A P U L S E 
A blati o n S yste m Pl us  pri or t o partici pati n g i n t he st u d y.  De vice trai ni n g will be 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 6 8  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
c o n d ucte d b y t he S p o ns or or its re pres e ntati ves .  All de vice trai ni n g will be 
d oc u me nte d i n a trai ni n g l o g t hat will be mai nt ai ne d i n t he Re g ulat or y Site Bi n der . 
9. 9  
Site Tr ai ni n g  
T o e ns ure acc urate, c o m plete a n d relia bl e data, t h e S p o ns or or its re pres e nt ati ves 
will pr o vi de i nstr ucti o nal material t o t he site, as a p pr o priate; i nstr uct t he 
i n vesti gat or a n d st u d y pers o n nel o n t he CI P , t he c o m pleti o n of t he C R Fs i ncl u di n g 
C R F I nstr u cti o ns , a n d st u d y pr oce d ures; c o m m u nicate re g ularl y wit h site pers o n nel 
via mail, e mail, tele p h o ne, a n d/ or fa x; a n d ma ke p eri o dic m o nit ori n g visits t o t he 
site.  D uri n g t h ose visits, t he S p o ns or or its re pres e ntati ves will m o nit or t he s u bject 
data rec or de d i n t he C R Fs a gai nst t he s o urce d o c u me nts at t he site  f or all e nr olle d 
s u bjects. 
9. 1 0  Cli nic al E ve nts a n d D at a M o nit ori n g C o m mittee  
T he S p o ns or has esta blis he d a n e xter nal gr o u p of e x pert p h ysicia ns w h o are n ot 
i nvesti gat ors t o ser ve as t he Cli nical E ve nts a n d Data M o nit ori n g C o m mittee 
(C E D M C).  T his gr o u p will c o nsist of a pa nel of 3 e x perie n ce d, i n de pe n de nt 
p h ysicia ns w h o are n ot i n vesti gat ors  a n d w h o will be s u p p orte d b y t he Me di cal 
M o nit or a n d St u d y Statisticia n. A c o m bi ne d c o m mittee is a n a p pr o priate str uct ure 
f or a 5 0 s u bject feasi bilit y st u d y.  
T he C E D M C  will c o n ve ne d uri n g t he st u d y t o scree n, classif y a n d a dj u dicate all 
a d verse e ve nts r e p orte d i n t he s u bject i n vesti gati o n as well as maj or st u d y 
o utc o mes . T he  C E D M C  will be pr o vi de d wit h cas e s u m maries , rel e va nt s o urce 
d oc u me nts a n d a n y ot her i nf or mati o n re q uire d t o e val uate a n d a dj u dicate t he 
a d verse e ve nts  a n d st u d y o utc o mes . 
T he C E D M C  will als o c o n ve ne t o re vie w safet y data a n d tre n ds d uri n g t he c o n d uct 
of t he st u d y.  T his f or mal assess me nt  will occ ur  at a mi ni m u m  after t he e nr oll me nt 
of 1 5 a n d t he n 5 0 s u bjects .  T he C E D M C  will rec o m me n d t o t he S p o ns or w het her a 
st u d y pa use or ter mi nati o n is re q uire d if it i de ntifies a tre n d t hat i n dicates a da n ger 
t o patie nt safet y.   
9. 1 1   D at a M a n a ge me nt  
Data ma na g e me nt pr oce d ures will be i ncl u de d i n t he St u d y Ma na ge me nt Pla n.  
eC R Fs  will be ma de a v aila ble t o t he partici pati n g site .  I n v esti gat ors are res p o nsi ble 
f or t he acc urate c o m pleti o n of patie nt eC R Fs  d uri n g t he st u d y. T he I n vesti gat or will 
e ns ure t hat c o m plet e, acc urate a n d ti mel y data in eC R Fs are c o m plet e d, t hat 
pr ot oc ol re q uire m e nts are f oll o we d, a n d t hat c o m plicati o ns, a d verse e ve nts a n d 
a d verse d e vice effects are c orrectl y re p orte d a n d i n vesti gate d, as a p pr o priat e.   T he 
I n v esti gat or is e x pecte d t o mai ntai n all s o urce d oc u me nts as re q uire d b y t h e CI P , 
i ncl u di n g la b orat or y res ults, s u p p orti n g me dical rec or ds, a n d si g ne d I C Fs.  T he 
s o urce d oc u m e nts will be use d d uri n g t he re g ular m o nit ori n g visits t o verif y 
i nf or mati o n a gai nst data c o ntai ne d in t he c o m plet e d eC R Fs.   eC R F d ata will be 
re vie we d t o i de ntif y a n y i nc o nsiste nt or missi n g data a n d a n y a d verse e v e nts.  A n y 
data iss ues are t o be pr o m ptl y a d dresse d wit h t he I n v esti gat or b y t he C R O.  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 6 9  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
After eC R F M o nit ori n g has bee n c o m plet e a n d d eficie nci es / discre pa n cies  
res ol ve d, st u d y data i n t h e ce ntr al data bas e  will be u p date d t o refl ect a n y c h a n ges .   
9. 1 2   St u d y S us pe nsi o n or E arl y Ter mi n ati o n  
T he st u d y ca n be disc o nti n ue d  at a n y site at t he dis creti o n of t he I n v esti gat or or 
st u d y S p o ns or f or reas o ns i ncl u di n g, b ut n ot li mite d t o, t he f oll o wi n g: 
•  Occ urre nce of a d v erse e ve nts u n k n o w n t o date i n res pect t o t heir nat ure, 
se verit y, or d urati o n, or t he u ne x pecte d i nci de nce of k n o w n a d verse e v e nts . 
•  O btai ni n g ne w sci e ntific k n o wle d ge t hat s h o ws t hat t he st u d y is n o l o n ger v ali d 
or necess ar y . 
•  Data de m o nstr ates a be nefit t o s u bjects w h o u n der g o perc uta ne o us a blati o n  
wit h t he F A R A P U L S E A blati o n S yste m Pl us  ma ki n g treat me nt wit h o ut t he 
F A R A P U L S E A blati o n S yste m Pl us  u net hical . 
•  I ns ufficie nt r ecr uit me nt of s u bjects. 
•  U na ntici pate d a d v erse d e vice effect ( U A D E) prese nti n g a n u nreas o na ble ris k 
t o s u bjects ( S p o ns or ma y ter mi nate t he st u d y i m me diatel y) 
•  Persiste nt n o n -c o m plia nce wit h t he Cli nical I n v esti gati o n Pla n.  
•  Persiste nt n o n -c o m plia nce wit h re g ulat or y re q uire me nts . 
If t he st u d y is disc o nti n ue d or s us pe n de d pre mat urel y, t he S p o ns or s hall pr o m ptl y 
i nf or m t he cli nical i n vesti gat or/ i n vesti gati o nal ce nter of t he ter mi nati o n or 
s us pe nsi o n a n d t he reas o n(s) f or disc o nti n uati o n / s us pe nsi o n .  T he nati o nal a n d 
l ocal re g ulat or y a ut h orities s hall als o be i nf or me d pr o m ptl y a n d pr o vi de d wit h t he 
reas o n(s) f or t he t er mi nati o n or s us pe nsi o n b y t he S p o ns or , C R O or b y t he cli nical 
i n vesti gat or/ i n vesti gati o n ce nter. F urt her, if t he st u d y is disc o nti n ue d or s us pe n de d 
pre mat urel y, p atie nts e nr olle d t o t hat p oi nt will c o nti n ue t o be f oll o we d f or safet y 
t hr o u g h t he 1 2-m o nt h ti me p oi nt.   
9. 1 3   Criteri a f or S us pe n di n g/ Ter mi n ati n g a St u d y Ce nter  
S p o ns or reser ves t he ri g ht t o st o p t he scree ni n g of s u bjects at t he st u d y ce nt er at a n y 
ti me after t he st u d y i nitiati o n visit if n o s u bjects ha ve bee n e nr olle d or if t he ce nter 
has m ulti ple or s e vere pr ot oc ol vi olati o ns wit h o ut j ustificati o n or fails t o f oll o w 
re me dial a cti o ns.  
P ossi ble reas o ns f or s us p e n di n g/ ter mi nati n g  t he st u d y ce nter i ncl u de, b ut are n ot 
li mite d t o: 
•  Re peate d fail ure t o c o m plete C R Fs pri or t o sc he d ule d m o nit ori n g visits;  
•  Fai l ure t o o btai n writte n inf or me d co ns e nt  usi n g t he E C -a p pr o ve d I C F ; 
•  Fail ure t o r e p ort S A Es/ U S A D Es t o S p o ns or wit hi n 2 4 h o urs of k n o wle d ge;  
•  L oss of ( or u n acc o u nte d f or) i n vesti gati o nal pr o d uct i n ve nt or y  or re peate d 
fail ure of de vice acc o u nt a bilit y. 
9. 1 4  De vi ati o ns fr o m t he Cli nic al I n vesti g ati o n Pl a n 
U n der e mer ge n c y circ u msta nces, de viati o ns fr o m t he CI P t o pr otect t he ri g hts, 
safet y, a n d well-bei n g of h u ma n s u bjects ma y pr ocee d wit h o ut pri or a p pr o val of t he 
S p o ns or or E C . 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 7 0  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
T he In vesti gat or m ust n otif y t he S p o ns or  a n d t he C R O of a n y de viati o n fr o m t he 
CI P a n d d oc u m e nt t he reas o n f or t he de viati o n  i n t he e C R F. 
T he In vesti gat or s hall n otif y t he S p o ns or a n d t he re vie wi n g E C of a n y de vi ati o n 
fr o m t he CI P , as per natio nal re q uire m e nts,  t o pr otect t he life or p h ysic al w ell-bei n g 
of a s u bject i n a n e mer ge nc y .  S uc h n otice s hall be gi ve n as s o o n as p ossi ble, b ut i n 
n o e ve nt later t ha n fi ve ( 5) w or ki n g da ys after t he e mer ge n c y occ urre d .  

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 7 1  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
1 0. Re g ul at or y C o nsi der ati o ns  
1 0. 1  M ai nt ai ni n g Rec or ds  
T he S p o ns or a n d C R O will mai ntai n c o pies of critical c orres p o n de nce, re g ulat or y 
a p pr o vals, Trial Mast er Files, cli nical data, s hi p me nt of de vices, a d v erse e v e nts, 
seri o us a d vers e e v e nts, seri o us a d verse de vice effects a n d ot her rec or ds rel ate d t o 
t he cli nical st ud y .  
Trial rec or ds will be mai ntai ne d f or a mi ni m u m of 1 5  years f oll o wi n g t he 
c o m pleti o n of researc h acti vities a n d cl os ure of t h e st u d y wit h Et hics C o m mittees, 
w hic he ver is l o n ger.  
1 0. 2   D at a H a n dli n g a n d Rec or d Kee pi n g  
10. 2. 1 S o urce D oc u me nts  
T he In vesti gat or m ust mai ntai n detaile d s o urce d oc u me nts o n all s u bjects w h o are  
e nr olle d or w h o u n d er g o scree ni n g i n t he st u d y .  S o urce d oc u m e nts i ncl u de b ut 
are n ot li mite d t o, s u bject me dical rec or ds, h os pital c harts, cli nic c harts, 
i n vesti gat or s u bject st u d y files, as well as t he res ults of dia g n ostic tests (e. g., 
la b orat or y tests, he m o d y na mic st u dies). 
T he f oll o wi n g mi ni m u m i nf or mati o n s h o ul d be e ntere d i nt o t he s u bject’s m e dical 
rec or d: 
•  T he date t he s u bject e ntere d t he st u d y a n d t he s u bject n u m ber . 
•  T he Cli nical I n v esti gati o n Pla n  n u m ber a n d t he na me of t he S p o ns or . 
•  T he date t hat I nf or me d C o nse nt was o btai ne d  a n d si g ne d b y t he patie nt a n d 
I n v esti gat or. 
•  E vi de nce t hat t he s u bject meets  t he st u d y eli gi bilit y re q uire me nts (e. g., 
me dical hist or y, st u d y pr oce d ures a n d/ or e v al uati o ns) . 
•  T h e dates of all st u d y relate d s u bject visits. 
•  E vi de nce t hat re q uire d pr oce d ures a n d/ or e v al uati o ns were c o m plete d . 
•  Use of a n y c o nc urre nt m e dicati o ns . 
•  D oc u me ntati o n of s pecific de vice us e d . 
•  Occ urre nce a n d stat us of a n y a d verse e v e nts ( A Es  / S A Es) 
•  T he date t h e s u bject e xite d t he st u d y a n d a n otati o n as t o w het her t he s u bject 
c o m plete d t he st u d y or was disc o nti n ue d, i ncl u di n g t he reas o n f or 
disc o nti n uati o n . 
10. 2. 2  D at a C ollecti o n  
T he In vesti gat or m ust mai ntai n detaile d rec or ds o n all s u bjects w h o si g n t he I C F 
a n d be gi n t he pre -pr oce d ure e val u ati o n .  Data f or e nr olle d s u bjects is tra ns cri be d 
o nt o eC R Fs pr o vi de d b y t he S p o ns or  or desi g nee .  All data s h o ul d be tra nscri be d 
c o m pletel y  a n d pr o m ptl y .   
St u d y  e xit e C R F will be c o m plete d f or all e nr olle d s u bjects, re gar dless of  w het her  
t he y di d or di d n ot c o m plete t he st u d y (e. g., s u bject disc o nti n uati o n, st u d y 
ter mi nati o n).  T he S p o ns or a n d i n vesti gati o nal site will mai ntai n all rec or ds 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 7 2  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
pertai ni n g t o t his st u d y i n acc or da nce wit h l ocal a n d nati o nal re g ulati o ns .  Pri or t o 
t he destr ucti o n of st u d y rec or ds t he In v esti gat or or his re prese nt ati ve s hall c o ntact 
t he S p o ns or t o e ns ure t hat t he y n o l o n ger nee d t o b e retai ne d.  I n a d diti o n, 
S p o ns or s hall be c o ntacte d if t he I n vesti gat or pla ns t o lea ve t he i n vesti gati o nal 
site s o t hat arra n g e me nts ca n be ma de f or t h e ha n dli n g or tra nsfer of st u d y 
rec or ds. 
1 0. 3  Et hics C o m mittee a n d C o m pete nt A ut h orit y A p pr o v al  
Re g ulat or y a p pr o vals m ust be o btai ne d pri or t o e nr o ll me nt of t he first patie nt.  T he 
S p o ns or is res p o nsi ble f or o btai ni n g r e g ulat or y a n d l ocal a p pr o vals f or t he st u d y .  
T he S p o ns or or its desi g nate d re prese ntati ve will re q uire a c o p y of a n y I C a n d C A 
c orres p o n d e nce, as well as t he fi nal a p pr o val letter fr o m t he E C a n d C A , w here 
a p plica ble.  
A n I n vesti gat or ma y n ot ma ke CI P c ha nges wit h o ut pri or a p pr o val b y t he S p o ns or .  
All si g nifica nt CI P c ha n g es t hat ma y affect t he f oll o wi n g m ust be s u b mitte d a n d 
a p pr o ve d b y t he E C a n d C A bef ore i nitiati n g t he c ha n ge:  
•  Vali dit y of t he data or i nf or mati o n res ulti n g fr o m t he c o m pleti o n of t he a p pr o ve d 
CI P  
•  Relati o ns hi p of t he li kel y s u bject ris k t o be nefit relie d u p o n t o a p pr o ve t he CI P  
•  Scie ntific s o u n d ness of t he CI P  
•  Ri g hts, safet y, or welfare of t he h u ma n s u bjects i n v ol ve d i n t he i n vesti gati o n  
T he S p o ns or will n otif y t he i n vesti gati o nal site of s uc h c ha n ges t o e ns ure t h e st u d y 
c o nti n ues t o be c o n d ucte d c o nsiste nt  wit h  t he a p pr o ve d CI P . 
1 0. 4  Pr oce d ure f or A me n di n g t he CI P  
T he pr ocess of a me n di n g t he CI P a n d/ or rel ate d d oc u me nts is t he 
res p o nsi bilit y of t he s p o ns or.  T he pr oce d ure f or a me n di n g t he CI P s h all be as 
f oll o ws: 
•  T he S p o ns or, I n vesti gat or, or ot her rele va nt part y (e. g. E C, C A, C E D M C) ma y 
rec o m me n d m o dificati o n of t he CI P.  
•  T he S p o ns or will t he n m o dif y as necessar y t he CI P a n d a n y ass ociate d d o c u me nts 
re q uiri n g a me n d me nt as a res ult of t he m o dificati o n(s). 
•  T he S p o ns or or desi g nat e d C R O will t he n s u b mit t he re vise d CI P a n d a n y ot her 
affecte d d oc u m e nts t o t he E C a n d C A f or a p pr o val, per re g ulati o n.  
•  O nce all re q uire d a p pr o vals are o btai ne d, t he site will be trai ne d t o t he latest 
a p pr o ve d versi o n of t he CI P a n d a n y ot h er affecte d d oc u me nts.  
 
1 0. 5  De vice A cc o u nt a bilit y  
T he In vesti gat or is res p o nsi ble f or mai ntai ni n g a D e vice A cc ou nta bilit y L o g t hat 
will trac k de vice recei pt, de vice usa g e f or all s u bjects  a n d de vice ret ur ns t o S p o ns or 
or desi g ne es.  I nf or mati o n trac ke d will i ncl u de d ate of de vice usa ge, s u bject I D, a n d 
l ot n u m ber. 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 7 3  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
1 1. P u blic ati o n P olic y  
T he e xiste nce of t his cli nical st u d y is c o nfi de ntial, a n d it s h o ul d n ot be disc usse d 
wit h pers o ns o utsi de of t he st u d y.  A d diti o nall y, t he i nf or mati o n i n t his d oc u me nt 
a n d re gar di n g t his st u d y c o ntai ns tra de secrets a n d c o m merciall y se nsiti ve 
i nf or mati o n t hat is c o nfi de ntial a n d ma y n ot be dis cl ose d u nless s uc h discl os ure is 
re q uire d b y re gi o nal or n ati o nal la w or re g ulati o ns.  S u bject t o t he f ore g oi n g, t his 
i nf or mati o n ma y be discl ose d o nl y t o t h ose pers o ns i n v ol ve d i n t he st u d y w h o ha ve 
a nee d t o k n o w, b ut all s uc h pers o ns m ust be i nstr ucte d n ot t o f urt her disse mi nate 
t his i nf or mati o n t o ot hers.  T hese restri cti o ns of discl os ure will a p pl y e q uall y t o all 
f ut ure i nf or mati o n s u p plie d t o y o u t hat is i n dicate d as c o nfi de ntial. 
T he data ge n erate d b y t his cli nical st u d y are t he pr o pert y of t he  S p o ns or a n d s h o ul d 
n ot be discl ose d wit h o ut t he pri or writte n per missi o n of F A R A P U L S E , I nc.  T hese 
data ma y be use d b y F A R A P U L S E , I nc.  n o w a n d i n t he f ut ure f or prese nt ati o n or 
p u blicati o n at F A R A P U L S E , I nc.’s d iscreti o n or f or s u b missi o n t o g o ver n me ntal 
re g ulat or y a g e ncies.  F A R A P U L S E , I nc.  reser ves t he ri g ht of pri or re vi e w of a n y 
p u blicati o n or prese ntati o n of data fr o m t he s u bj ect i n vesti gati o n. 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 7 4  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
1 2. Bi bli o g r a p h y 
 
1  
Pa ge R L.  Ne wl y Dia g n ose d Atrial Fi brillati o n.  Ne w E n gl a n d J o ur n al of 
Me dici ne , 3 5 1( 2 3): 2 4 0 8– 1 6, 2 0 0 4.  
2  
Fei n ber g W M, C or nell E S, Ni g hti n gale S D, et al.  Relati o ns hi p bet wee n 
Pr ot hr o m bi n Acti vati o n Fra g me nt F 1. 2 a n d I nter nati o nal N or malize d Rati o i n 
Patie nts wit h Atrial Fi brillati o n.  Str o ke Pre ve nti o n i n Atrial Fi brillati o n  
3  
F uster, V, R y de n, L, Asi n ger , R, et al.  A C C/ A H A/ E S C G ui deli nes f or t he 
Ma na ge me nt of Patie nts wit h Atrial Fi brillati o n: E xe c uti ve S u m mar y.  J A m 
C oll C ar di ol , 2 0 0 1; 3 8: 1 2 3 1-6 5.  
4  
G o A S, H yle k E M, a n d et al.  P hilli ps K A.  Pre vale nce of di a g n ose d atri al 
fi brillati o n i n a d ults: nati o nal i m plicati o ns f or r h yt h m ma na ge me nt a n d str o ke 
pre ve nti o n: t he a ntic oa g ulati o n a n d ris k fact ors i n atrial fi brillati o n (atria) 
st u d y.  J A M A, 2 8 5: 2 3 7 0– 5, 2 0 0 1.  
5  
Mi yasa ka Y., Bar n es M E., et al.  Sec ular Tre n ds i n I n ci de nce of Atrial 
Fi brillati o n i n Ol mste d C o u nt y, Mi n nes ota, 1 9 8 0 t o 2 0 0 0, a n d I m plicati o ns o n 
t he Pr ojecti o ns f or F ut ur e Pre vale nce.  Circ ul ati o n.  2 0 0 6; 1 1 4: 1 1 9 -1 2 5.   
6  
W olf P A, A b b ott R D,  Ka n nel W B.  Atrial fi brillati o n as a n i n de pe n d e nt ris k 
fact or f or str o ke: t he Fra mi n g ha m St u d y.  Str oke  1 9 9 1; 2 2: 9 8 3 –  8.  
7  
Le He uze y J Y, Pazi a u d O, Pi ot O, et al.  C ost of care distri b uti o n i n atrial 
fi brillati o n patie nts: t he C O C A F st u d y.  A m He art J  2 0 0 4; 1 4 7: 1 2 1 –  6.  
8  
Cal ki ns, et al.  H R S/ E H R A/ E C A S E x pert C o nse ns us State me nt o n Cat heter 
a n d S ur gical A blati o n of Atrial Fi brillati o n: Rec o m me n dati o ns f or Pers o n nel, 
P olic y, Pr oce d ures a n d F oll o w -U p.  He art R hyt h m  2 0 1 7; 1 4:e 2 7 5 -4 4 4.  
9   
Al -Sa kere B, A n dre´ F, et al.  T u m or A blati o n wit h Irre v ersi ble 
Electr o p orati o n.  P L o S O N E  2( 1 1): e 1 1 3 5.  
1 0   
Ne u mc ke, B., Walz, D., L ~ u ger, P.  1 9 7 0.  N o n li near effects i n li pi d bila yer 
me m bra nes.  III.  T he diss ociati o n fiel d effect.  Bi o p h ys.  J.  1 0: 1 7 2  
1 1   
Be nz R, Bec kers F, Zi m mer ma n n U.  Re versi ble electrical brea k d o w n of li pi d 
bila yer me m bra n es: a c h ar ge -p ulse rela xati o n st u d y.  J Me m br Bi ol.  1 9 7 9 J ul 
1 6; 4 8( 2): 1 8 1 -2 0 4.  
1 2   
C ha n g, D.  C.  1 9 8 9a.  Cell p or ati o n a n d cell f usi o n usi n g a n oscillati n g 
electric fiel d.  Bi o p h ys.  J.  5 6: 6 4 1 -6 5 2.  
1 3   
D. C.  C ha n g, T. S.  Reese C ha n ges i n me m bra ne str uct ure i n d uce d b y 
electr o p orati o n as re v eal e d b y ra pi d-freezi n g electr o n micr osc o p y.  
Bi o p h ysical J o ur nal, V ol u me 5 8, I ss u e 1, J ul y 1 9 9 0, Pa ges – 1 2  
1 4   
We n dler JJ, Pec h M, Blasc h ke S et al ( 2 0 1 2) A n g i o gra p h y i n t he is olate d 
perf use d ki d n e y: ra di ol o gical e val uati o n of v asc ular  pr otecti o n i n tiss ue 
a blati o n b y n o nt her mal irre versi ble electr o p orati o n.  Car di o vasc I nter ve nt 
Ra d i ol 3 5: 3 8 3– 3 9 0  
1 5   
Ge hl J 1, S k o vs gaar d T, Mir L M.  Vasc ular reacti o ns t o i n vi v o 
electr o p orati o n: c haracterizati o n a n d c o ns e q ue nces f or dr u g a n d g e ne 
deli ver y.  Bi oc hi m Bi o p h ys Acta.  2 0 0 2 Ja n 1 5; 1 5 6 9( 1 -3): 5 1 -8.  
 

F A R A P U L S E  F A R A -F R E E S T U D Y  
F E B R U A R Y  2 0 2 0  
C S 0 7 6 6 , R E VI SI O N C  
 
P A G E 7 5  
 
C O N FI D E N TI A L  
 
© 2 0 2 0 , F ar a p ulse, I nc. 
 
1 6   
Ki n g ha m T P, Kar kar A M, D’ A n gelica MI et al  ( 2 0 1 2) A blati o n of 
peri vasc ular he patic m ali g na nt t u m ors wit h irre versi ble  electr o p orati o n.  J A m 
C oll S ur g 2 1 5: 3 7 9 – 3 8 7  
1 7   
Ol we n y E O, K a p ur P, Ta n Y K et al  ( 2 0 1 3) Irre versi ble electr o p orati o n: 
e val uati o n of n o nt her m al a n d t her mal a blati ve ca p a bilities i n t he p orci ne 
ki d ne y.  Ur ol o g y 8 1: 6 7 9 – 6 8 4  
1 8   
Ma or E, I v orra A, Le or J, R u bi ns k y B.  Irre v ersi bl e electr o p orati o n atte n uat es 
ne oi nti mal f or mati o n after a n gi o pl ast y.  I E E E Tra ns Bi o me d E n g.  2 0 0 8 
Se p; 5 5( 9): 2 2 6 8 -7 4.  
1 9   
T h o ms o n K R 1, C he u n g W, et al.  I n vesti gati o n of t he safet y of irre versi ble 
electr o p orati o n i n h u ma ns.  J V asc I nter v R a di ol.  2 0 1 1 Ma y; 2 2( 5): 6 1 1 -2 1  
2 0   
Witt ka m pf F H 1, va n Dri el VJ, et al.  Feasi bilit y of electr o p orati o n f or t he 
creati o n of p ul m o nar y vei n ostial lesi o ns.  J C ar di ov asc Electr o p hysi ol.  2 0 1 1 
Mar; 2 2( 3): 3 0 2 -9.  
2 1   
Va n Driel VJ, Ne ve n K G, P ul m o nar y vei n ste n osis after cat heter a blati o n: 
electr o p orati o n vers us ra di ofre q ue n c y .  Circ Arr hyt h m Electr o p hysi ol.  2 0 1 4; 
7( 4): 7 3 4 -8.  
2 2   
Ne ve n K, v a n Driel V, et al.  E picar dial li near electr o p orati o n a blati o n a n d 
lesi o n size.  He art R hyt h m .  2 0 1 4; pii: S 1 5 4 7-5 2 7 1( 1 4 ) 0 0 4 5 9-7.