Multi Center, Prospective, Non-Randomized, Single-Arm Trial Evaluating the Clinical Safety and Performance Of the HeartWare MVAD® System For the Treatment of Advanced Heart Failure
Phase: NA
Conditions: Heart Failure
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

 
 
 
 
 
11 Nov 2
 
Multi 
Investiga
CIP Num
Version 
IDE Num
Date: 
 
 
 
 
 
This Clin
property
represen
regulato
confiden
availabl
HeartWa
 
 
 
2014 
Center, P
F
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mber: 
Number:   
mber:  
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CO
 
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N/A 
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NFIDENTIAL
 
 
 
 
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 11 Nov 
 
1.0 
1.1 
Medica
Sponsor 
Sponsors
Officer  
Sponsor 
Sponsor 
Manufa
 
 
1.2 
Authoriz
Address
 
 
 
1.3 
Authoriz
Address
 
 
 
 
 
2014 
ADMINS
Sponsor C
l, Clinical a
Name: 
s Responsib
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European
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: 
Australia
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TRATIVE IN
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ort 
HeartWare, 
 
+1 508 739 0
+1 508 739 0
4400 NW 60
Miami Lakes
USA 
entative 
 
MedPass Int
Windsor Hou
vesham  
Worcs. WR1
sentative 
 
HeartWare P
8 Pitt Street
evel 10 
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Australia 
Clinical Inve
L 
Inc. 
 
 
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0948 
0th Avenue
s, FL 33014
 
ternational 
use, Bretfort
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VAD®
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Final 
01223
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 11 Nov 
 
1.4 
CIP  Num
Revision
CIP Date
IDE Num
Investiga
 
1.5 
D
 
 
2014 
CIP Adm
mber:  
 Number: 
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mber: 
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Amendm
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HW
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Page 3 o
nt Type  
VAD®
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Final 
01223
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 11 Nov 
 
1.7 
I will pro
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l Plan – VP0
Page 5 o
nent 
of the study
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he Institution
ive.  
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administrativ
th fully.  
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01223
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nal 
riate 
ve 
with 
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in 
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cal 
any 
ten 
ment 
d 
ood 

 
 
 
 
 11 Nov 
 
Table of 
1.0 
A
1
1
1
1
1
1
1
2.0 
ST
3.0 
St
3
4.0 
IN
4
4
5.0 
D
5
5
5
5
5
5
5
5
2014 
f Contents 
ADMINSTRAT
.1 
Spo
.2 
Euro
.3 
Aus
.4 
CIP 
.5 
Am
.6 
Spo
.7 
Inve
TUDY SUMM
tudy Refere
.1 
List 
NTRODUCTI
.1 
Bac
.2 
Nam
DEVICE DESC
.1 
MVA
5.1.
5.1.
.2 
Prin
5.2.
5.2.
5.2.
5.2.4
5.2.
5.2.
5.2.
.3 
Hea
5.3.
.4 
PAL
5.4.
5.4.
5.4.
.5 
PAL
.6 
PAL
.7 
PAL
5.7.
5.7.
.8 
Dev
TIVE INFORM
onsor Conta
opean Auth
tralian Auth
Administra
endment H
onsor CIP Ap
estigator Ag
MARY 
ence Inform
of Abbrevia
ON 
ckground a
me and Inte
CRIPTION 
AD® System
1 
MVAD
2 
MVAD
ciples of O
1 
Backg
2 
Blood 
3 
Physio
4 
Flow E
5 
Suctio
6 
qPulse
7 
Pump
artWare® M
1 
Monito
L™ Controll
1 
Contro
2 
Pal™ C
3 
Power
L™ Batteries
L™ Battery C
L™ Controll
1 
AC Ad
2 
DC Ad
vice Accou
 
CO
 
MATION
acts .............
horized Rep
horized Rep
ative Inform
History .........
pproval .....
greement ..
mation
ations .........
nd Rationa
ended Use 
m..................
D® System  O
D® System C
peration ...
ground .......
Flow Chara
ological Co
Estimation ..
on Detectio
e™ Cycle ..
 Pressure A
onitor ........
or Overview
er ...............
oller Featur
Controller I
r Sources fo
s ..................
Charger ....
er AC Adap
dapter .......
dapter .......
untability ....
C
NFIDENTIAL
....................
presentative
presentative
ation ..........
....................
....................
....................
....................
ale ...............
....................
....................
Overview ...
Component
....................
....................
acteristics ..
ntrol Algorit
....................
n & Respon
....................
lgorithm .....
....................
w .................
....................
res & Conne
nternal Bat
or the Pal™
....................
....................
pter or DC 
....................
....................
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Clinical Inve
L 
....................
e .................
e .................
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ts ................
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thms...........
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nse..............
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ectors ........
ttery ............
™ Controller 
....................
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Adapter ...
....................
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Hea
Study No
V
estigational
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 11 Nov 
 
6.0 
ST
6
6
6
6
7.0 
ST
7
7
7
8.0 
P
8
8
8
8
8
8
9.0 
ST
9
2014 
TUDY OBJEC
.1 
Stud
.2 
Estim
6.2.
6.2.
.3 
Prim
.4 
Sec
TUDY DESIG
.1 
Num
.2 
Sub
.3 
Site
atient Popu
.1 
Cha
8.1.
8.1.
.2 
Incl
.3 
Exc
.4 
Crit
.5 
Proc
.6 
Sub
TUDY PROC
.1 
Stud
9.1.
9.1.
9.1.
9.1.4
9.1.
9.1.
9.1.
Pres
9.1.
9.1.
9.1.
9.1.
9.1.
9.1.
9.1.
9.1.
9.1.
9.1.
9.1.
CTIVES AND
dy Objectiv
mated Perio
1 
Time s
2 
End of
mary Endpo
condary End
GN 
mber of Clin
bject Partici
Selection C
ulation, Sele
aracterizati
1 
AHA S
2 
Definit
usion Criter
lusion Crite
eria for Disc
cedure for 
bject Follow
CEDURES, D
dy Procedu
1 
Inform
2 
Point o
3 
Inform
4 
Demo
5 
Demo
6 
Cardio
7 
Hemo
ssure Mana
8 
Docum
9 
Echoc
10 
NYHA 
11 
NIH St
12 
Six min
13 
Qualit
14 
Kansa
15 
Implan
16 
MVAD
17 
MVAD
18 
Safety
 
CO
 
D ENDPOINT
ves ..............
od of Trial ..
schedule ...
f trial ..........
oint ..............
dpoints ......
nical Sites a
pation and
Criteria ......
ection and 
on of Study
Stage D, NY
tion of Opti
ria ...............
ria ..............
continuatio
Discontinua
w- up after tr
EVICE EXPL
ures .............
med Consen
of contact 
ming the sub
ographics, M
ography .....
ovascular/ 
odynamic p
agement Pla
mentation 
cardiogram
classificatio
roke Scale/
nute walk ..
ty of life Qu
as City Card
nt Data .....
D® Pump Pa
D® Pump Lo
y Laborator
C
NFIDENTIAL
T MEASURES
....................
....................
....................
....................
....................
....................
and Subject
d Study Dura
....................
Withdrawa
y Population
YHA Class III
imal Medic
....................
....................
on or Withdr
ation or Wit
rial comple
LANT AND S
....................
nt Procedur
....................
bject’s gene
Medical His
....................
Medical hi
parameters/
an (IBPM) ..
of Concom
m/ qPulse™ ..
on/ INTERM
/ Modified 
....................
estionnaire
diomyopath
....................
arameters ..
og Files ........
ry Investiga
Clinical Inve
L 
S (ENDPOIN
....................
....................
....................
....................
....................
....................
ts .................
ation ..........
....................
al
n .................
IB/IV Heart 
cal Manage
....................
....................
rawal of a S
thdrawal of
etion or earl
TUDY EVAL
....................
re ...............
....................
eral practit
story, and P
....................
story & Hos
/ Vital Signs
....................
mitant Medi
....................
MACS Patien
Rankin Sca
....................
e (EuroQol E
hy Question
....................
....................
....................
tions ...........
Hea
Study No
V
estigational
NTS)
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
Failure .......
ement (OM
....................
....................
Subject .......
f a Subject .
ly terminati
UATIONS 
....................
....................
....................
tioner ..........
Physical Exa
....................
spitalization
s & Improve
....................
ications ......
....................
nt Profile .....
ale ................
....................
EQ-5D-5L) ...
nnaire (KCC
....................
....................
....................
....................
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on ..............
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amination ...
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n ...................
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9
9
9
9
10.0 
A
1
1
1
2014 
9.1.
9.1.
9.1.
9.1.
9.1.
9.1.
9.1.
.2 
Dev
9.2.
.3 
Post
.4 
Sch
9.4.
9.4.
9.4.
9.4.4
9.4.
9.4.
9.4.
9.4.
9.4.
9.4.
.5 
Sub
ADVERSE EV
0.1 
Def
10.1
10.1
10.1
10.1
10.1
10.1
10.1
10.1
10.1
coll
0.2 
Asse
10.2
10.2
10.2
0.3 
Adv
10.3
10.3
10.3
10.3
19 
Hospit
20 
Subjec
21 
Discha
21.1  IBPM T
22 
Out of
22.1  MVAD
23 
Re-ho
vice Explan
1 
Devic
t- Study Clin
edule of O
1 
Scree
2 
Scree
3 
Enrollm
4 
Implan
5 
In Hos
6 
Hospit
7 
Month
8 
Month
9 
Explan
10 
Post-E
bject Death
VENTS 
initions and
1.1 
Adver
1.2 
Seriou
1.3 
Devic
1.3.1  Adver
1.3.2  Devic
1.3.3  Seriou
1.3.4  Unant
1.4 
Antici
1.4.1  The an
ected are:
essment of 
2.1 
Not re
2.2 
Possib
2.3 
Relate
verse Event
3.1 
Invest
3.1.1  AE Re
3.1.2  MVAD
3.1.3  Timelin
 
CO
 
tal LOS (Len
ct training .
arge Trainin
Training ......
f Hospital A
D® Pump Ex
spitalization
t .................
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nical Follow
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nt ...............
pital ...........
tal Discharg
h 1 and 3 ...
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nt of MVAD
xplant Con
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d documen
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us Adverse E
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e deficienc
us Adverse D
ticipated Se
pated/ Exp
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...................
Causality ..
elated.........
bly related .
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t Reporting 
igator Repo
porting ......
D® Pump Ma
nes .............
C
NFIDENTIAL
ngth of Stay
....................
ng ................
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Assessment .
it Site/Drive
n..................
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w- up ...........
s and Proce
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24 and Exp
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ntinuing Sub
....................
ntation of a
AE): ..............
Event (SAE)
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Effect (ADE
cy (DD) .......
Device Effe
erious Adve
pected Adv
/ expected 
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Requireme
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alfunctions
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Clinical Inve
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y) ................
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edures .......
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umentation
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ents .............
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Study No
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 11 Nov 
 
11.0 
D
1
1
1
1
1
1
1
1
12.0 
ST
1
1
1
1
1
1
1
1
13.0 
B
1
1
14.0 
ET
1
1
1
1
1
1
2014 
10.3
10.3
10.3
DEVICE AND
1.1 
Pre-
1.2 
Imp
1.3 
Post
1.4 
Infe
1.5 
Ant
11.5
11.5
1.6 
Bloo
1.7 
Dev
1.8 
Crit
TATISTICAL 
2.1 
Gen
2.2 
Ana
2.3 
Prim
2.4 
Sec
2.5 
Ana
2.6 
Oth
2.7 
Adv
2.8 
Stud
ENEFIT AND
3.1 
Pote
3.2 
Risk
THICAL ASP
4.1 
Ethi
4.2 
Sub
4.3 
Inde
14.3
4.4 
Insu
4.5 
Reg
4.6 
Inve
14.6
14.6
14.6
14.6
14.6
14.6
3.2 
Regula
3.3 
Conta
3.4 
Study/
D SUBJECT M
-Implant De
plant Proced
toperative 
ection Cont
icoagulatio
5.1 
Pre Im
5.2 
Post Im
od Pressure
vice Speed 
eria for Ret
CONSIDERA
neral Statist
alysis Popula
mary Endpo
condary End
alysis Sites ...
her Seconda
verse Event
dy Retentio
D RISK ANAL
ential Bene
k Analysis ....
PECTS 
cal Consid
bject Inform
ependent E
3.1 
Invest
urance ........
gulatory Aff
estigators a
6.1 
Invest
6.1.1  Invest
6.1.2  Financ
6.1.3  CIP De
6.2 
HeartW
6.3 
Contra
 
CO
 
atory Repo
acting Hear
/ Implant C
MANAGEME
evice Mana
dure ...........
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trol ..............
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15.0 
D
1
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16.0 
A
1
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17.0 
A
1
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1
2014 
14.6
DOCUMENTA
5.1 
Cas
5.2 
Dat
15.2
15.2
15.2
15.2
15.2
5.3 
Dat
5.4 
Dat
5.5 
Dat
ADMINISTRA
6.1 
Mon
6.2 
Inde
6.2.1 
DSM
6.2.2 
DSM
6.2.3 
CEC
6.3 
Qua
16.3
16.3
16.3
6.4 
Mai
6.5 
Sub
6.6 
CIP 
6.7 
Com
16.7
16.7
6.8 
Rec
6.9 
Site
6.10 
Con
6.11 
Pub
6.12 
Fina
6.13 
Org
APPENDICES
7.1 
Time
17.1
17.1
7.2 
New
7.3 
INTE
6.4 
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ATION OF T
se Report Fo
ta Manage
2.1 
Data M
2.2 
eCRFs
2.3 
Codin
2.4 
Patien
2.5 
Source
ta Review ..
ta Quality A
tabase lock
ATIVE REQUI
nitoring of t
ependent D
MB and CEC
MB ...............
C .................
ality System
3.1 
Qualit
3.2 
Audit .
3.3 
Inspec
intenance 
bject Data P
Modificatio
mpliance/ I
7.1 
Comp
7.2 
Invest
cord Retent
Training ....
nfidentiality
blication po
al report .....
ganization/ 
S 
e and Even
1.1 
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1.2 
Follow
w York Hear
ERMACS Pro
 
CO
 
Ware (Clinic
TRIAL DATA
orms ..........
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s ..................
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the Study ..
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Site person
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o. HW-MVA
Version 7.0 
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97 
.... 97 
.... 97 
.... 97 
.... 97 
.... 97 
.... 97 
.... 98 
.... 98 
.... 99 
.... 99 
100 
.. 100 
.. 100 
.. 100 
.. 100 
.. 101 
.. 101 
.. 101 
.. 101 
.. 102 
.. 102 
.. 102 
.. 103 
.. 103 
.. 103 
.. 103 
.. 104 
.. 104 
.. 104 
.. 104 
.. 105 
.. 105 
106 
.. 106 
.. 107 
.. 108 
.. 109 
.. 110 

 
 
 
 
 11 Nov 
 
1
1
1
1
1
1
1
1
1
18.0 
R
19.0 
S
 
 
2014 
7.4 
NIH 
7.5 
Proc
7.6 
Qua
7.7 
Kan
7.8 
Sub
17.8
17.8
17.8
17.8
7.9 
Adv
7.10 
Infe
7.11 
Ant
7.12 
Dow
EFERENCES
UB- STUDY F
Stroke Sca
cedure for 
ality of life Q
nsas City Ca
bject Trainin
8.1 
HeartW
8.2 
Samp
8.3 
Blood 
8.4 
Samp
verse Event
ection Cont
icoagulatio
wnload of M
S 
FLOW ESTIM
 
 
CO
 
le ...............
6 Minute W
Questionna
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Ware MVAD
le Patient E
Pressure M
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trol Guidelin
on Guidelin
MVAD® Pum
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C
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.. 145 
146 
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 11 Nov 
 
2.0 
Name of 
HeartWa
Title of CI
Multi Cen
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Trial Num
Number o
60 subjec
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The prima
the MVA
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2. 
3. 
4. 
5. 
6. 
7. 
8. 
9. 
10. 
11. 
12. 
13. 
Safety As
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the Minia
and mon
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review of
 
2014 
STUDY SU
Sponsor(s):
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Frequenc
Definition
Length of
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ical Safety a
Heart Failure.
mum of 10 site
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or recovery 
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 11 Nov 
 
Device: M
The MVA
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Intended
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stage he
The MVA
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Fo
Period of
Estimated
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2014 
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ents to impla
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lowing majo
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 11 Nov 
 
Backgrou
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agree to use 
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on of the stu
artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 14 o
erall, 50% of h
e world suffe
5 million cas
lation have 
nsplantation 
ack of availa
wide.4   
ventricular a
s are used to
e while awai
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ntation. The 
l and 
Pump is an 
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tion and diu
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VAD®
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heart 
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ses in 
is 
able 
assist 
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iting a 
with 
ion 
use of 
mall 
plicity, 
at 
cardial 
dure. 
e 
retics, 
ntra-
ve 
ptives 

 
 
 
 
 11 Nov 
 
Main Crit
1. B
2. B
3. P
4. Ex
b
5. P
6. H
7. A
c
h
8. O
9. P
to
10. Sy
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11. U
12. Se
m
13. A
la
te
m
14. U
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tim
15. In
th
16. Se
17. Sp
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18.  A
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20. Su
21. Et
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2014 
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25. P
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to
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29. Te
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30. Em
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Trial Proc
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oyees 
lant) 
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52.5% 
ssible 

 
 
 
 
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3.0 
3.1 
Abbrev
ACE 
AC or D
ACC 
ADE 
ACT 
AE 
AHA 
ALT 
ARB 
AST 
ASA 
BiVAD 
BMI 
BPC 
BSA 
BTT 
cc 
CA 
CFR 
CHF 
CIP 
CK 
CK- MB
COPD 
CRF 
CRO 
CRP 
CRT 
CSS 
CT 
CVA 
CVP 
DD 
dL 
2014 
STUDY RE
List of Ab
viation 
DC 
 
EFERENCE
bbreviation
Definition
Angioten
Alternati
America
Adverse
Activate
Adverse
America
Alanine 
Angioten
Aspartat
Acetylsa
Biventric
Body Ma
Blood Pr
Body Sur
Bridge to
Cubic C
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Code of
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Clinical I
Creatine
Creatine
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Case Re
Clinical R
C- Reac
Cardiac
Clinical S
Comput
Cerebra
Central V
Device D
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ns 
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tent Author
f Federal Re
Heart Failu
Investigatio
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e Kinase MB
Obstructive
eport Form
Research O
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a milliliter) 
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n 
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CQ 
stroke) 
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VAD®
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Final 
01223
of 153

 
 
 
 
 11 Nov 
 
Abbrev
DNR 
eCRF 
ECG 
ECMO 
EDC 
EEC 
EEG 
EQ-5D-5
EU 
FEV1 
GCP 
g 
HEPA 
HF 
HPA 
hr 
IABP 
IBPM 
ICD 
ICF 
ICH 
ICU 
IEC 
IFU 
INR 
INTERM
ISHLT 
ISO 
ITT 
KCCQ 
kg 
LCD 
LDH 
LED 
Li-Ion 
L/min 
2014 
viation 
5L 
ACS 
Definition
Do Not R
Electron
Electroc
Extracor
Electron
Europea
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EuroQoL
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Europea
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Good C
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High-Effic
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High Pre
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Intensive
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InterAge
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nd 5 levels 
atory 
ation 
VAD®
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Final 
01223
of 153

 
 
 
 
 11 Nov 
 
Abbrev
LOS 
LV 
LVAD 
LVEDD 
LVEDV 
LVEF 
LVESD 
LVESV 
MAP 
MCS 
MCSD 
MEDDE
m 
Mg 
MI 
mL 
Mm 
MRS 
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NIHSS 
NYHA 
NP 
OMM 
OR 
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PCWP 
PG1 
PG2 
PI 
PP 
PRBC 
Pt  (or P
PTT 
PVO2 
PVR 
QoL 
RAP 
2014 
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Pts) 
Definition
Length o
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Left Ven
Left Ven
Left Ven
Left Ven
Left Ven
Left Ven
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Mechan
Medical
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Milligram
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Milliliter 
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Modified
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New Yor
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Optimal 
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Overall C
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Medical M
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l Investigato
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heart failure
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VAD®
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Final 
01223
of 153

 
 
 
 
 11 Nov 
 
Abbrev
RGA 
RHC 
RPM 
RV 
RVAD 
RVEF 
SADE 
SAE 
SAF 
SGOT 
SGPT 
SVO2 
TIA 
TTR 
UK 
USADE 
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WBC 
 
 
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Returned
Right He
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Right Ve
Right Ve
Right Ve
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Serious A
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Page 20 o
VAD®
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Final 
01223
of 153

 
 
 
 
 11 Nov 
 
4.0 
4.1 
Heart fa
estimate
prevalen
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ld.  It is 
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cies 
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 11 Nov 
 
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 11 Nov 
 
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Version 7.0 
l Plan – VP0
Page 23 o
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 11 Nov 
 
5.1.2 M
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MVAD® Syste
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artWare MV
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Version 7.0 
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Page 24 o
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Version 7.0 
l Plan – VP0
Page 25 o
on 
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 11 Nov 
 
Com
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artWare MV
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Version 7.0 
l Plan – VP0
Page 26 o
on 
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 11 Nov 
 
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Page 27 o
on 
dapter use
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 11 Nov 
 
5.2 
5.2.1  B
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5.2.2 B
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artWare MV
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Version 7.0 
l Plan – VP0
Page 29 o
path (Figure
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 11 Nov 
 
operatio
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artWare MV
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Version 7.0 
l Plan – VP0
Page 30 o
any speed 
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 11 Nov 
 
The MVA
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 31 o
by monitor
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VAD®
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ring 
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onse 
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 11 Nov 
 
during a
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2014 
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 32 o
ed on the lo
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 11 Nov 
 
5.2.6 q
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 33 o
ysiology by
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 11 Nov 
 
5.2.7 P
The MVA
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Study No
V
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 34 o
hydrodyna
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Final 
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of 153
mic 
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 11 Nov 
 
5.3 
5.3.1 M
The mon
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 35 o
ftware to 
ontroller 
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01223
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mp 
d on 
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ry 
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 11 Nov 
 
MV
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 36 o
ory Default
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VAD®
AD-01 
Final 
01223
of 153
t 
ed to 

 
 
 
 
 11 Nov 
 
5.4.1 C
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Study No
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sts of an LC
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 37 o
CD touchscr
screens 
ckground c
alarm, 
the pump 
a reinforced
cable. The 
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01223
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color 
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eline. 
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 11 Nov 
 
Pal™ Ca
attache
protect 
5.4.2 P
The con
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 38 o
attery is not
purpose is to
D® Pump an
d to provide
ery, AC 
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ould never b
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Final 
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ller 

 
 
 
 
 11 Nov 
 
 
5.4.3 P
Except w
external
connec
plug into
power fr
time. The
external
internal 
batterie
Patients 
power is
change
after rec
5.5 
For safe 
controlle
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times. 
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many as
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 11 Nov 
 
When th
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can be 
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er or 
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tery 
e 
, 
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 11 Nov 
 
Batt
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ery Chargin
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l Plan – VP0
Page 41 o
ons. If 
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n the 
d on 
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s are 
ly 
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 11 Nov 
 
The DC 
vehicle 
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5.8 
The MVA
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personn
number 
unused 
 
 
2014 
adapter (Fi
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Version 7.0 
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Page 42 o
d pump fro
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ntability Log
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01223
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om a 
er 
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g. All 

 
 
 
 
 11 Nov 
 
6.0 
6.1 
This mult
and per
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alive on 
for recov
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2014 
STUDY O
Study Ob
ti-center, pr
rformance o
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INTS) 
igate the sa
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ment.  Safet
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afety 
ty 
for 
t 
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me 

 
 
 
 
 11 Nov 
 
6.4 
1. Su
e
2. O
3. In
4. In
d
5. In
6. In
7. H
Q
8. Fu
9. Fr
IN
10. Le
11. R
12. Tr
13. Ex
2014 
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urvival at 24
endpoint) 
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Version 7.0 
l Plan – VP0
Page 44 o
ke the prim
RMACS 
athy 
alk 
port per 
VAD®
AD-01 
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01223
of 153
ary 

 
 
 
 
 11 Nov 
 
7.0 
7.1 
The trial 
to 5 cou
Screenin
It is antic
No site w
from He
7.2 
Subjects
All subje
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The stud
enrollme
Quarter 
7.3 
Factors d
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this trial,
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2014 
STUDY D
Number 
will be con
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Subject P
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complete b
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artWare MV
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Version 7.0 
l Plan – VP0
Page 45 o
n (10) sites in
and Austra
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alia.  
h. 
until 
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l, 
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ctice 

 
 
 
 
 11 Nov 
 
8.0 
8.1 
The stud
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manage
ethnicity
Prior to e
exclusio
8.1.1 A
The disti
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patient 
failure o
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occurrin
 
2014 
PATIENT 
Characte
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enrollment, 
n criteria. 
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CTION AN
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Page 46 o
Association
medical 
ender, race
one of the 
ased upon 
periences 
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mptoms at r
t provide 
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n 
 or 
the 
B 
rest.  
ying 
or by 
a, 
is 

 
 
 
 
 11 Nov 
 
8.1.2 D
Optimal
tolerable
Many pa
therapy 
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D/NYHA
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used in t
intraven
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 
Deve
stabl
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class
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Definition of 
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e therapy w
 
Ang
Ang
 
Diur
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Beta
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Aldo
atients will a
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elopment o
ersensitivity 
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ting in deve
urrence of 
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imal tolerab
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retics 
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tinuous the
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ents who ha
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for heart fai
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s.   
 
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rapy with in
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azine/nitrat
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nsitivity to a
artWare MV
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Version 7.0 
l Plan – VP0
Page 47 o
n and max
tes. In addi
hmic agen
ny Stage 
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01223
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tion, 
nts 
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ously 
major 
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sts) 
rapy.  
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 11 Nov 
 
8.2 
1. M
2. Su
th
3. Le
4. Fe
c
su
d
5. Th
8.3 
1. B
2. B
3. P
4. Ex
in
5. P
6. H
7. A
w
a
8. O
im
9. P
to
10. Sy
st
c
11. U
12. Se
e
sc
2014 
Inclusion
Must be ≥18
ubjects with
he following
a. on op
diuret
or 
b. in Cla
intra-
eft ventricu
emale subj
contracepti
urgical con
duration of t
he subject 
Exclusion
ody Mass In
ody Surfac
artial or full
xistence of 
ntra-aortic b
rior cardiac
History of co
Acute myoc
wave chang
abnormalitie
On ventilato
mplant.  
ulmonary e
omography
ymptomati
tenosis of c
circulation. 
ncorrected
evere right 
extracorpore
creening. 
n Criteria 
 years of ag
h advance
g): 
ptimal med
tics, for at le
ass III or Cla
aortic ballo
ular ejection
ects of chil
ve precaut
ntraceptives
the study. 
has signed 
n Criteria 
ndex (BMI) 
e Area (BSA
 mechanic
any ongoi
balloon pum
c transplan
onfirmed, un
cardial infar
ges on ECG
es.  
or support fo
embolus wit
y (CT) scan 
c cerebrov
arotid or cr
d moderate
ventricular
eal membr
 
CO
 
ge at conse
ed heart fail
ical manag
east 45 out
ss IV heart f
oon pump (
n fraction ≤
dbearing p
tions (define
s or a comb
the informe
> 47.  
A) < 1.0 m2.
cal circulato
ng mechan
mp (IABP) o
t or cardiom
ntreated ab
rction within
G, diagnosti
or > 72 hou
thin three w
or nuclear 
vascular dis
ranial vesse
e to severe 
r failure as d
rane oxyge
C
NFIDENTIAL
ent  
lure sympto
gement inc
 of the last 
failure for a
(IABP) and/
≤25%. 
potential mu
ed as oral c
bination of 
ed consent
. 
ory support 
nical circula
or TandemH
myoplasty.
bdominal o
n 14 days o
ic biomarke
rs within the
weeks of im
scan. 
ease, stroke
els in the ab
aortic insuf
defined by 
nation (ECM
Clinical Inve
L 
oms (Class I
cluding diet
60 days an
at least 14 d
/or inotrope
ust agree to
contracept
condom a
t form (ICF)
within thirty
atory suppo
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or thoracic 
of implant a
ers, ongoing
e four days 
plant as do
e within 180
bsence of c
fficiency.  
the anticip
MO) or BiVA
Hea
Study No
V
estigational
IIB or IV) wh
tary salt res
nd are failin
days and de
es. 
o use adeq
tives, intrau
and spermic
. 
y days of im
ort (MCS) o
®. 
aortic aneu
as diagnose
g pain and
immediate
ocumented
0 days of im
confirmed c
pated need
AD at the t
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Version 7.0 
l Plan – VP0
Page 48 o
ho meet on
triction and
ng to respon
ependent o
quate 
uterine devi
cide) for the
mplant. 
other than a
urysm >5 cm
ed by ST or T
d hemodyna
ely prior to 
d by compu
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ime of 
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80% 

 
 
 
 
 11 Nov 
 
13. A
a
e
ta
a
14. U
c
a
15. In
p
su
16. Se
17. S
w
18. A
c
19. P
p
20. Su
21. E
d
m
22. H
re
5
23. P
w
24. Se
25. P
26. P
27. P
a
28. Su
29. Te
ju
30. E
o
m
2014 
Active, unco
and laborat
elevated tem
achycardia
antifungal tr
ncorrected
count <75,00
anticoagula
ntolerance 
postoperativ
ubject’s he
erum creat
pecific liver
within 72 ho
A total biliru
cirrhosis or p
ulmonary v
pharmacolo
ubjects with
tiology of h
disease, obs
myocarditis 
History of sev
estrictive lun
0% predicte
articipation
weeks prior t
evere illnes
eripheral va
regnancy a
sychiatric d
are likely to 
ubject unw
echnical ob
udgment of
mployees o
other trials u
members or
ontrolled inf
ory testing,
mperature 
a, generaliz
reatment. 
d thromboc
00, INR >2.0
ation therap
to anticoag
ve therapy 
alth status. 
tinine >3.0 m
r enzymes [
urs of impla
bin >3 mg/
portal hyper
vascular res
ogical man
h a mecha
heart failure
structive ca
or restrictiv
vere chroni
ng disease 
ed value). 
n in any oth
to screenin
s, other tha
ascular dise
and breastf
disease, irre
impair com
willing or una
bstacles, w
f the investi
of the inves
nder the di
r employee
 
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 including b
and white 
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cytopenia o
0 or PTT >2.5
py).  
gulant or a
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mg/dL with
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rtension. 
sistance (PV
ipulation. 
nical heart
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her trial invo
g and last v
an heart dis
ease with re
feeding. 
eversible co
mpliance wi
able to com
hich pose a
igator. 
stigator or tr
irection of t
s of the Inv
C
NFIDENTIAL
gnosed by 
but not limi
blood cell 
e despite ap
or generaliz
5 times con
ntiplatelet 
vestigator m
in 72 hours 
), and ALT (
2 hours of im
VR) is demo
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or associate
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ve pulmon
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olving inves
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sease, whic
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ardial disea
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ry volume in
tigational d
trial. 
ch would lim
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function or
and LVAD.
rial requirem
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h direct inv
gator or tria
Hea
Study No
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estigational
ation of clin
ntinued pos
unt, hypoten
antibiotic, 
opathy (e.g
absence of 
or any othe
nister based
or requiring
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ase, amyloid
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drugs or de
mit survival t
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urgical risk, 
volvement i
l site, as we
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Version 7.0 
l Plan – VP0
Page 49 o
nical sympto
sitive culture
nsion, 
antiviral or 
g., platelet 
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d upon the 
g dialysis. 
er limit of no
ven liver 
ponsive to 
thyroid 
dosis, active
r severe 
ond (FEV1) <
vices within
to <3 years.
 extremities
cial issues th
in the 
n this trial o
ell as family 
VAD®
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Final 
01223
of 153
oms 
es, 
ormal 
e 
< 
n 4 
. 
s. 
hat 
or 

 
 
 
 
 11 Nov 
 
8.4 
The prim
should b
Section 
1. Lo
a
su
2. V
fo
sh
w
3. St
re
4. O
8.5 
A subjec
during th
for termi
perform 
prior to t
Month 2
8.6 
After co
specific 
registry o
2014 
Criteria fo
mary reason
be noted us
9.4.2.   
ost to follow
attempts to 
ubject must
Voluntary w
or withdraw
hould be m
where possib
tudy termin
egulatory a
Other. NOTE
Procedur
ct may disc
he study.  S
ination mus
all proced
that visit, or
24.  Disconti
Subject F
ompletion o
VAD Follow
or follow- up
or Disconti
n for discont
sing the foll
w-up.  The s
contact th
t be docum
ithdrawal.  
wal, if provid
made to det
ble, the prim
nation. The 
agency term
E: The speci
re for Disco
continue his
hould a sub
st be record
ures sched
r the Month
inued or wi
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w- up progr
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CO
 
inuation or
tinuation or
owing cate
subject did 
e subject w
mented. 
The subjec
ded, should
termine the
mary under
sponsor, Ind
minates the
fic reasons 
ontinuatio
s or her part
bject’s part
ded in the e
uled for the
h 24 visit if d
thdrawn su
after trial 
udy visit the
ram and ma
C
NFIDENTIAL
r Withdraw
r withdrawa
egories. For
not return t
were unsucc
t wishes to 
d be record
e underlying
rlying reaso
dependent
e study. 
should be 
n or Withd
ticipation w
ticipation b
eCRF.   In a
e Month 6, 
iscontinuat
ubjects will n
completio
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ay have the
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L 
wal of a Su
al of the sub
r screen fail
to the clinic
cessful. All a
withdraw f
ded in the e
g reason fo
on should b
t Ethic Com
recorded in
rawal of a
without givin
be discontin
addition, eff
12 and 18 v
tion is after 
not be repla
on or early 
will continue
e possibility
Hea
Study No
V
estigational
bject 
bject from 
ure subject
c and at lea
attempts to
rom the stu
eCRF.  NOTE
r the withd
e recorded
mmittee (IEC
n the eCRF
a Subject 
ng a reason
nued, the p
forts should
visit if disco
Month 18 b
aced. 
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o. HW-MVA
Version 7.0 
l Plan – VP0
Page 50 o
the study 
ts, refer to 
ast three 
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C), or 
. 
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uded in a 
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he 
ason 
pts 
 
me 
son 
to 
is 
site 

 
 
 
 
 11 Nov 
 
9.0 
9.1 
The follo
conduc
personn
Section 
perform 
Month 1
14 days 
9.1.1 In
Before e
perform
informed
with an 
given to
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required
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meets e
months 
Vulnerab
9.1.2 P
A point o
the subje
each su
9.1.3 In
In certai
general 
agreem
the trial 
enrollme
with the
 
2014 
STUDY PR
Study Pro
owing sectio
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9 and also 
evaluation
, 3 there is 
and for visi
nformed Co
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Information
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 be confirm
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 general pr
ROCEDUR
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in Append
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onsent Proc
e subject in
en ICF must
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n Sheet sum
cts to consid
med by the 
ng and dat
dical record
assessments
o confirm eli
eria and sig
may be us
tions will no
tact 
of where to
hom to con
nformation
e subject’s 
ble countrie
er or other e
alth care pr
ent. The pro
 trial, and t
ractitioner s
 
 
CO
 
RES, DEVIC
e the proce
ts are to be
  The Sched
ices 17.1.1 
esignated ti
of + 7 days
h 12, 18 the
cedure 
 the trial, i.e
t be obtaine
al and what
mmarizing th
der their pa
subject an
ing the con
d. 
s obtained w
igibility; and
gns the ICF
sed for scre
ot be includ
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ntact in the 
n will be spe
general pr
es, and in ca
equivalent 
rovider is to
ovider shou
he dates o
should be d
C
NFIDENTIAL
CE EXPLAN
edures to b
e assessed b
dule of Stud
and 17.1.2.
ime points. 
for visits at 
re is a wind
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t participat
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within the 3
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ractitioner
ases where
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ld be inform
f the outsta
documente
Clinical Inve
L 
NT AND ST
be complet
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dy Procedu
.Every attem
However, f
Month 6, 2
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any trial-rela
otential pa
tion entails. 
of the trial. A
. Agreemen
cipal investig
Document
30 days prio
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diograms o
asurements.
rial. 
formation o
rial-related 
e ICF. 
e the subjec
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ed of the su
med of the 
anding visits
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Hea
Study No
V
estigational
TUDY EVA
ted through
me investiga
ures is descr
mpt should
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24 there is a
days.  
ated exami
articipant sh
They shall 
Ample time
nt to partic
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tation of thi
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asurements
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. 
on the trial, 
injury will b
ct is typicall
then with t
ubject’s pa
title of the 
s. The comm
bject’s med
artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 51 o
LUATIONS
hout the 
ator or site 
ribed here i
 be made 
nducted at
a window of
ination is 
hall be 
be supplied
e should be
cipate in the
uthorized 
is procedur
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thin the 6 
on the righ
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he subject’
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trial, date o
munication
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in 
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 11 Nov 
 
9.1.4 D
9.1.4.1 
Demogr
on the e
Subject 
* per co
9.1.4.2 
Medica
includes
With co-
Childhoo
not nee
 
2014 
Demograph
Demograp
raphic data
eCRF includ
BMI and BS
ountry speci
Cardiovasc
l history will 
s diagnosis, 
 
Gen
 
Prim
 
Prev
 
Cur
 
Prev
 
Etio
 
Dur
 
Num
 
Smo
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 
Dia
 
CO
 
Prev
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 
NYH
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d to be doc
ics, Medica
phy 
a that will b
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SA will also b
ific regulati
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be collect
general m
neral medic
mary cardia
vious cardia
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logy of Hea
ation of He
mber of hos
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rotid artery 
pheral vasc
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al History, a
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on 
ical history
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ac diagnosis
ac surgery
anical supp
hanical circ
art Failure 
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spitalization
ntified as  
, oral, insulin
ological eve
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cular disea
tion 
nsidered to
. 
C
NFIDENTIAL
and Physica
d and iden
ender, weig
ed.  
& Hospitali
corded for a
ory and car
s 
port (ECMO
ulation sup
ns in past ye
n) 
ent 
se 
 be relevan
Clinical Inve
L 
al Examinat
tified by a 
ght, height,
ization 
all subjects 
rdiovascula
O, balloon p
pport 
ear for card
nt to the eti
Hea
Study No
V
estigational
tion 
non-identify
, race and 
enrolled in
ar history as
pump) 
diac 
iology of he
artWare MV
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Version 7.0 
l Plan – VP0
Page 52 o
ying numbe
ethnicity*. 
 the trial.  T
s follows: 
eart failure,
VAD®
AD-01 
Final 
01223
of 153
er 
his 
, do 

 
 
 
 
 11 Nov 
 
9.1.5 H
P
9.1.5.1 
Hemody
screenin
(where a
 
Heart Ra
Respirat
Temper
Systolic 
Diastolic
Mean A
(MAP)3 
Doppler
Central 
SVO2 
Right at
Systolic 
pressure
Diastolic
pressure
Mean p
pressure
PCWP 
Cardiac
Cardiac
PVR 3 
*if availa
1 follow IB
2 After sc
3 Auto ca
the Time
availabl
availabl
in some 
availabl
deviatio
RHC will 
2014 
Hemodynam
lan (IBPM) 
Hemodyna
ynamic par
ng/ pre-imp
applicable
ate/ Rhythm
tory Rate 
ature 
blood pressu
c blood pres
Arterial Blood
r - Pressure 
venous pres
rial pressure2
pulmonary a
e2 
c pulmonary
e2 
pulmonary ar
e3 
c Index 
c output 
ble  
BPM program
creening only
alculatedEve
e and Event
e only durin
e due to RH
subjects w
e due to RH
on.  Howeve
be docum
mic parame
amic param
rameters w
plant, day 1
):  
m 
ure 
ssure 
d Pressure 
ssure2 
2 
artery 
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m (Section 9
y to be colle
ery effort sh
t Schedules
ng right hea
HC monitor
ho have a 
HC monitor
er, the abilit
mented in th
 
CO
 
eters/ Vital 
meters/ Vita
ill include th
-3, and mo
Screening
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
.1.5.2) as ap
ected in case
hould be ma
s (Appendix
art cathete
ring.  In add
VAD impla
ring or impla
ty/inability t
he eCRF, as
C
NFIDENTIAL
Signs & Imp
al Signs 
he following
onth 1, 3, 6, 
Day 
post im
x
x
x
x
x
x
x
x*
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1-3  
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M
* 
ht Heart Failu
ain hemod
owever, so
HC) monito
e paramete
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emodynam
Hea
Study No
V
estigational
od Pressure
ill be captu
and re-hos
Month 1, 3, 6, 
x 
x 
x 
x1 
x1 
x1 
x1 
 
x* 
 
 
 
 
 
 
 
 
ure  
dynamic ass
me parame
ring, while o
ers may not
mic parame
dered to be
mics due to
artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 53 o
e Managem
ured at 
pitalization
12, 18, 24 
sessments p
eters are 
others are n
t be availa
eter that is n
e protocol 
o presence 
VAD®
AD-01 
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01223
of 153
ment 
 
per 
not 
ble 
not 
of a 

 
 
 
 
 11 Nov 
 
9.1.5.2 
General
From the
by the M
method
While bo
arterial l
values in
Followin
an IBPM
subjects
(Automa
Followin
3 month
the reco
medica
Stability 
plan will
at mont
blood p
blood p
After co
hospitali
complia
will cont
until sub
All blood
as any in
the thera
Method 
HeartWa
subjects
cuffs of 
The prot
current H
requires 
pulse an
2014 
IBPM, Mea
Documenta
l 
e Instruction
MVAD® Syste
 and ≤ 90 m
oth device 
ine measur
n non-pulsa
g discharge
 plan, in ad
s/caregivers
ated cuff o
g discharge
hs and cont
ommended
lly appropri
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 be assesse
hly intervals
ressure is vo
ressure ma
ontinuous m
izations, sta
ance. For su
tinue for an
bjects are st
d pressure m
ntervention
apeutically
of Measure
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s. It is anticip
different siz
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only that su
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n Arterial Bl
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ns For Use (I
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s MAP mea
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measureme
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ze will be pr
ood pressur
US ENDURA
ubjects be 
ho do not. F
 
CO
 
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IFU), the rec
mmHg (as t
subjects wh
es yield MA
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ts and a sm
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asurements
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o have not 
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re measure
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For subjects
C
NFIDENTIAL
ure (MAP) A
commende
olerated) fo
ho use the D
AP values w
cuff metho
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ood Pressur
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ed on Time 
post-discha
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3 months po
quarterly (
met the sta
. This will be
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changes to
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ferent sizes 
sites.  
ements is sim
plemental Tr
o 2 groups:
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or subjects 
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o maintain t
documente
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will be req
milar to that
rial. It is simp
: those that
lpable radi
Hea
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V
estigational
Procedure
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using an a
uff method. 
oximately 5 
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 are require
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l Plan – VP0
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e and 
jects suppo
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 11 Nov 
 
method
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cuff/Dop
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2014 
 of blood p
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systolic and
MAP 
the subjec
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also be pro
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nd in the eC
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for cuff/Do
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be provide
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m Hg throug
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Version 7.0 
l Plan – VP0
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utomated c
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 11 Nov 
 
the site v
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2 
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For subje
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via FAX, em
ately report
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on 2 success
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medications
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se within 48
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Version 7.0 
l Plan – VP0
Page 56 o
ects must 
ds 95 mm H
notify the si
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 11 Nov 
 
9.1.6 D
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tration of a
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o. HW-MVA
Version 7.0 
l Plan – VP0
Page 57 o
E inhibitors), 
s, 
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 11 Nov 
 
9.1.7 Ec
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alve openin
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o. HW-MVA
Version 7.0 
l Plan – VP0
Page 58 o
ptured at 
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x 
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 11 Nov 
 
9.1.8 N
AHA and
of NYHA
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pre-imp
The site’
INTERMA
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9.1.9 N
Nationa
to Appe
month 1
assessm
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the even
9.1.10 Si
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6, 12, 18
distance
Append
9.1.11 Q
The EQ-5
utilized. 
feasible)
9.1.12 K
This stud
administ
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24.   
 
2014 
NYHA classif
d NYHA cla
A classificati
an or qualifie
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ACS Patient
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NIH Stroke S
l Institutes o
endix 17.4), 
, 3, 6, 12, 18
ent, NIH Str
Stroke Scale
nt to docum
ix minute w
s will compl
, 24.  If the 
e recorded 
dix 17.5. 
Quality of life
5D-5L (refer
 Pre-implan
) and mont
Kansas City 
y will use th
tered instru
ent change
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assification g
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ed physicia
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onth 1, 3, 6
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of Health St
when feasi
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oke Scale i
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ment any d
walk 
ete a six m
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ment that q
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deficits. 
inute walk 
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2, 18, 24. 
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refer to App
quantifies p
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pendix 17.7
physical fun
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7), a disease
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endix 17.2.  
ssessor (de
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Appendix 17
 the medic
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4 weeks (+/
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e six-minute
rocedure a
ral well-bei
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ptoms (freq
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nd month 1
artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 59 o
Determina
fined as a 
rse practitio
t screening/
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7.3). 
cal files. 
ale (MRS) (r
plant and 
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8, 

 
 
 
 
 11 Nov 
 
9.1.13 Im
The surg
9.1.14 M
Flow (L/m
then da
and dai
Post disc
the patie
9.1.15 M
The PalTM
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visits at m
After ev
mvadlog
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2014 
mplant Data
gical implan
Date
Surg
Card
Aort
Con
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Drive
Start
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MVA
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min), Speed
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 60 o
he ICU and 
18, and 24
ameters dai
Section 9.1
in the log fi
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linic 

 
 
 
 
 11 Nov 
 
9.1.16 Sa
Laborat
implanta
collecte
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 61 o
VAD® Pump
es will be 
nancy Test 
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 11 Nov 
 
9.1.17 H
At disch
Addition
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9.1.18 S
9.1.18.1 
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2014 
Hospital LOS
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LOS 
LOS 
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nal subject 
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points as ass
7.8.2).  
Comprehen
diagnostic a
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When the w
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after every 
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Version 7.0 
l Plan – VP0
Page 62 o
r the follow
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ion. 
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trial 
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 11 Nov 
 
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pressure m
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Version 7.0 
l Plan – VP0
Page 63 o
e events an
accessible
  
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 11 Nov 
 
9.1.19 O
While ou
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Version 7.0 
l Plan – VP0
Page 64 o
Investigato
to call the s
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VAD®
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Final 
01223
of 153
or’s 
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cted 
M 

 
 
 
 
 11 Nov 
 
9.2 
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MVAD®.
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Device E
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AD® Pump s
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akes, FL 330
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Version 7.0 
l Plan – VP0
Page 65 o
ecovery, de
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 11 Nov 
 
9.3 
Subjects
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Informe
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Version 7.0 
l Plan – VP0
Page 66 o
ove into a 
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VAD®
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Final 
01223
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visit 
 

 
 
 
 
 11 Nov 
 
9.4.1 Sc
Prior to M
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Version 7.0 
l Plan – VP0
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01223
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a, 
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 11 Nov 
 
9.4.3 E
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01223
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 11 Nov 
 
9.4.4 Im
Implants
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l Plan – VP0
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omy. In all 
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 11 Nov 
 
9.4.7 M
The follo
9.4.8 M
The follo
9.4.9 Ex
2014 
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untoward 
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Version 7.0 
l Plan – VP0
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or outcome
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10.1.4.1 
Potentia
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Version 7.0 
l Plan – VP0
Page 75 o
 are:  
Possi
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 11 Nov 
 
Potentia
Pleural 
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malform
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artWare MV
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Version 7.0 
l Plan – VP0
Page 76 o
Possi
Devi
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Ye
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VAD®
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 11 Nov 
 
10.2 
The likely
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10.2.1 N
Is define
10.2.2 P
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be exclude
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Version 7.0 
l Plan – VP0
Page 77 o
cal device w
medical de
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p 
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 11 Nov 
 
10.3.1.2 
Any susp
or comp
enginee
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10.3.3 C
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 11 Nov 
 
11.0 
11.1 
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f the 
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 11 Nov 
 
11.4 
It is reco
Append
11.5 
11.5.1 P
Prior to a
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11.6 
Blood pr
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Post Imp
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vessels t
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lower lim
 
2014 
Infection
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rovided in 
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mal 
PTT, 
turn 
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 11 Nov 
 
11.8 
Subjects
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following 
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01223
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 11 Nov 
 
12.0 
12.1 
All data 
data list
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collected 
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s and subje
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nted.  
n, 
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ory, 
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nted 

 
 
 
 
 11 Nov 
 
12.3 
The prim
alive on 
for recov
follow-u
of the p
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HA: πMVA
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follow-u
 
2014 
Primary E
mary endpo
the MVAD
very and ex
p will be eli
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The survival
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01223
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ects 
ants 
onth 
me 
nce 
5% 
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 11 Nov 
 
12.5 
The stud
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2014 
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data 
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 11 Nov 
 
12.7 
Adverse
months. 
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 11 Nov 
 
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14.0 
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 11 Nov 
 
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 11 Nov 
 
14.3.1 In
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 11 Nov 
 
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 11 Nov 
 
14.6.2 H
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 11 Nov 
 
15.0 
15.1 
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 11 Nov 
 
15.2.5 So
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riginal reco
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 11 Nov 
 
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the selectio
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Final 
01223
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on of 
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e 
 

 
 
 
 
 11 Nov 
 
16.0 
16.1 
HeartWa
frequen
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wo committ
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rs (at least 
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DSMB 
MB will review
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the first MV
from the c
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ts that, duri
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dent Data 
ethical resp
ps that hav
llows: 
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al Events Co
ese commi
CEC Comp
tees will inc
(CEC).  Eac
two physici
ly involved 
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ty review w
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At these visit
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modified
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HeartWa
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 11 Nov 
 
16.3.3 In
Inspectio
docume
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16.4 
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 
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Subjects
investiga
investiga
All inform
concern
All data 
subject. 
parties in
All subje
disclosur
their age
agencie
 
2014 
nspection  
on is the ac
ents, facilitie
lated to the
CRO, or at o
ator is oblig
Maintena
estigator mu
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EC Approva
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lectronic Si
nvestigator 
Curriculum V
inancial Dis
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aboratory A
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mation and
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nvolved.  A
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es or review
ct by regula
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other facilitie
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ust maintain
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Visit Log 
Accreditati
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ts or their p
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All data sha
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HeartWare
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o. HW-MVA
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eview of the
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study: 
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ative, 
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he use and
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her governm
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Final 
01223
of 153
e 
ies 
Ware, 
The 
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 11 Nov 
 
16.6 
Change
CIP will b
Depend
amendm
relevant
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without 
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where n
change
If an am
subjects
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for revie
affected
the new
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Complia
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An initia
the spo
notice is
terminat
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2014 
CIP Modi
es to the CIP
be signed b
ding on the 
ment will be
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estigator sho
agreemen
al/favorable
necessary to
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mendment s
s or affects 
and submit
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w subjects 
Complia
Compliance
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nsor or by 
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nter closure
the investi
advance of
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ollment. 
stigational
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and regula
mination  
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gator, prov
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mplete cas
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ns 
o comply w
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nnel at Hea
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ny deviatio
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any of the f
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estigational
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mendments.
d by the Inv
al requirem
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ew and do
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he trial.  
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to consent
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aken at any
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ory 
ions for Use
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artWare MV
o. HW-MVA
Version 7.0 
l Plan – VP0
Page 103 o
. The amen
vestigator(s
ments, the 
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ocumented
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e 
VAD®
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Final 
01223
of 153
nded 
s).  
 
cept 
he 
e 
As, 
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ng 
sent 
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 11 Nov 
 
16.8 
HeartWa
reports. 
(listed a
manufa
section 4
if the Prin
investiga
In the ev
for inspe
and pro
The trial 
retained
16.9 
Sites will 
appropr
provided
16.10
The resu
any form
clause. 
16.11
The spon
study. Th
reviewe
publicat
Coordin
agree. A
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submitte
publicat
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2014 
Record R
are and all 
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bove) and 
cture of the
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ncipal Inve
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vent of a C
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master file,
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m or fashion
 Publicati
nsor and th
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tions will be
ating Inves
All editorial 
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are reserves
ed for publi
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ments. 
of discrepa
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participatin
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stigator pla
   
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n. All person
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ure or card
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stigator/Inve
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gator(s). 
s the right t
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a copy of a
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ill be submi
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ther party h
affect poss
other contr
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ators must e
he signed I
or at least 15
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cal regulatio
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tor must allo
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any Observa
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surgical jou
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estigational
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o. HW-MVA
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Page 104 o
n records a
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of the 
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study recor
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pts of 
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sible if all pa
Coordinatin
trial before 
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ubmission 
all prevail. 
VAD®
AD-01 
Final 
01223
of 153
and 
on 
6, 
cted 
rds 
dit 
be 
as 
in 
this 
r-
arties 
ng 
 it is 
 

 
 
 
 
 11 Nov 
 
16.12
An interi
aspects
HeartWa
Investiga
HeartWa
1 year a
16.13
It may b
technici
trial at a
personn
file. 
2014 
2 Final repo
im report (a
, will be pre
are, and th
ator(s) will b
are will prov
after the end
3 Organiza
be necessar
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a site under 
el taking pa
ort 
after 6 mon
epared. This
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be provided
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ation/ Site 
ry to define
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the auspic
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al or on req
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l site person
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estigational
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o. HW-MVA
Version 7.0 
l Plan – VP0
Page 105 o
and statistic
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vestigator’s
VAD®
AD-01 
Final 
01223
of 153
cal 
e 
e 
s site 

1
 
 
 
 
11 Nov 2014 
17.0 APPE
17.1 Time
 
ENDICES 
 and Event Sc
 
 
CONF
 
chedules  
Clinic
FIDENTIAL 
H
Study 
al Investigation
HeartWare MV
No. HW-MVAD
Version 7.0 F
nal Plan - VP01
Page 106 of
VAD®
D-01 
Final 
1223
f 153

1
E
I
I
D
C
I
S
(
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S
H
I
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I
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D
N
6
N
Q
K
C
A
1
4
a
 
 
 
 
11 Nov 2014 
17.1.1 Screeni
Event / Assessment
nformed Consent  
nclusion/Exclusion 
Demographics 
Cardiovascular/ Me
NTERMACS Patient 
Subject training 
(HeartWare MVAD® 
Urine Pregnancy Scr
Safety  Laboratory  
Hemodynamic  Para
BPM & Diary Assessm
Echocardiogram 3 
mplant Data  
MVAD® Pump Param
Log File Download 
Driveline Care Asses
NYHA Classification
6-Minute Walk 
NIH Stroke Scale / M
Quality of Life Quest
Kansas City Cardiom
Concomitant Medic
Adverse Events  
1 Day 3 only  
2
4 Implant=Day 1 
5
any subsequent hos
 
ng to Month 24
edical history & Hosp
Profile 
 and BP Managem
reen  
Chemistry and Hem
ameter/ Vital signs 2
ments2 
meters 5  
ssment  
Modified Rankin Sca
tionnaire (EuroQol E
myopathy Question
cations 
2 Detailed schedules
5 MVAD® Pump para
spitalization    6 In ad
 
 
CONF
 
4 
72
pitalization/ 
ent) 
matology 
2 
le 6 
EQ-5D-5L) 
naire (KCCQ) 
s in Section 9.1.5 of 
ameters will also be 
ddition obtain MRS 
Clinica
FIDENTIAL 
Screening/  
Pre-implant 
2 hours before 
Implant 
D
Ho
X 
X 
X 
X 
 
X 
X 
X 
 
X3 
 
 
X 
X 
X 
X 
X 
X 
X 
CIP 
3 Echocardi
recorded daily pos
and NIHSS at time o
H
Study 
al Investigation
Day 1-3/ 
During initial 
ospitalization 
Disc
 
 
X1 
X 
 
X4 
X 
 
 
X 
X 
ograms obtained w
t discharge until the
of stroke and at 12 w
HeartWare MV
No. HW-MVAD
Version 7.0 F
nal Plan – VP01
Page 107 of
charge 
Month  1,
+/-7  day
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
within the 6 months p
e patient’s blood p
weeks and 24 weeks
VAD®
D-01 
Final 
1223
f 153
, 3   
ys 
Month 6 
+ 14 days 
 
 
 
 
 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
prior to ICF may be 
pressure is stable as 
ks post-stroke (+/- 7 d
Month 12, 18    
+/-14 days 
Mo
+ 1
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
used for screening 
defined in Section 9
days)  
onth   24    
14 days 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
9.1.5.2 and at 

1
E
V
C
A
 
 
11 Nov 2014 
17.1.2 Follow-
Event / Assessm
Visit Date / Sur
Concomitant M
Adverse Event
up after Expla
ment 
rvival Status  
Medications 
ts 
 
 
CONF
 
nt of MVAD® P
Clinica
FIDENTIAL 
ump 
Explant
 
 
X 
X 
H
Study 
al Investigation
Month 
post expl
+/-7  da
X 
 
 
HeartWare MV
No. HW-MVAD
Version 7.0 F
nal Plan – VP01
Page 108 of
1 
lant
ays
Month 6
post expla
+/-30  da
X 
 
 
VAD®
D-01 
Final 
1223
f 153
6 
ant
ays 
Month 1
post expl
+/-30  da
X 
 
 
12 
ant
ays

T
t
A
A
S
A
 
 
11 Nov 2014 
17.2 New 
The subject’s fu
trial) by utilizing
ACC/AHA vs. N
ACC/AHA Stage
Stage 
A 
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FIDENTIAL 
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fication below
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ly associated w
have no identifi
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m, 
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York Heart Assoc
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ity 
ciation

 
 
 
 
 11 Nov 2
 
17.3 
 
Pr
Pa
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rofile 3: stab
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ability.” 
efinitive int
rofile 4: Res
atient can 
ymptoms of
uctuate at 
rategies sh
ompliance
may shuttle 
efinitive int
rofile 5: Exe
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ving predom
ongestive s
atus, often 
unction are 
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tical cardio
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burn.” Defin
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thin the ho
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C
NFIDENTIAL
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ck:               
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ng inotropic
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s 
                  
   
 
        
n 
ort 
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y, 
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ire 
nd 
     

 
 
 
 
 11 Nov 2
 
 
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Pa
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Pr
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2014 
rofile 6: Exe
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daily living a
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eful measur
mic monitor
ounded.” Va
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vanced NY
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tion or circu
 
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ce of fluid o
and minor a
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ariable, de
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HA III 
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overload is 
activities ou
ngful activi
peak oxyge
firm severity
pends upo
pecification
episodes o
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port may no
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comfortab
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ty. Attributi
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on maintena
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estigational 
 
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and with 
atigues afte
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me cases w
ent.  
trition, orga
cludes patie
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ion. 
ted. 
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er 
on 
with 
an 
ents 

 
 
 
 
 11 Nov 2
 
17.4 
NIH Strok
The NIH S
that asse
consciou
sensory l
Modified
Modified
to indep
obtained
structure
will be us
the scree
define n
 
 
 
2014 
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ke Scale (N
Stroke Scal
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usness, dysa
oss and vis
d Rankin Sc
d Rankin Sc
pendently p
d using a st
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ke Scale  
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arthria, extr
ual-field los
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ale is a vali
perform day
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gest the pre
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ra ocular m
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id estimate
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terview cre
s highly relia
esence of n
re-existing) 
r a neurolog
C
NFIDENTIAL
 
a widely use
ccident sym
movement, l
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 of global d
ctivities of d
eated by W
able. An M
neurologica
score is 4, t
gical event
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ed simple n
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Wilson et al. 
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ased on a p
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al evaluatio
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patient's ab
ore will be 
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n 3 (i.e., 4 or
ological eve
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ect, 
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bility 
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ent. If 

 
 
 
 
 11 Nov 2
 
17.5 
Location
The 6-mi
enclosed
reported
hallway 
turnarou
starting l
marked 
Patient P
1. C
2. A
3. Pa
4. Th
5. A
6. Pa
Measure
1. Repe
intrad
2. A wa
3. The p
10 m
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equip
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Start 
2014 
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nute Walk t
d corridor w
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is required.
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ine which m
on the floo
Preparation
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atients shou
he patients
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atients shou
ements 
eat testing s
day variabi
arm up perio
patient shou
inutes befo
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he lap coun
pment (lap
uct the pati
tes.  You w
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usted.  You
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ber of laps 
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test (6MWT)
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shoes for w
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ility. 
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nute Walk 
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object is to w
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C
NFIDENTIAL
 
Test 
e performed
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course must
rridor should
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and end of 
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worn 
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early morn
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click it each
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way.  Six m
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stop, and t
me walking
cones.  You 
way withou
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and pivot a
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Study No
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estigational 
along a long
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ters in lengt
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to keep tra
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g, flat, straig
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th.  A 35 me
meters.  The
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ould be 
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eter 
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A 
.) 
test 
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You 
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m 
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rting 

 
 
 
 
 11 Nov 2
 
1. Positi
durin
start 
2. Do n
stand
lose c
lap c
After
well. 
When
tell yo
When
chair
bag 
1. Reco
2. Reco
guide
recor
3. Cong
 
*E
 
Si
2014 
on the pati
g the test.  
the timer. 
ot talk to a
dard phrase
count of th
counter onc
r the first min
 You have 
n the timer 
ou to stop. 
n the timer 
r if they look
or piece of
ord the num
ord the add
es.  Calcula
rd it on the 
gratulate th
Excerpted f
ix-Minute W
ient at the 
Do not wa
nyone durin
es of encou
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ce.  Let the 
nute, tell th
five minute
is 15 secon
 When I do
rings, say th
k exhausted
f tape on th
mber of laps
ditional dista
ate the tota
worksheet
he patient o
from the Am
Walk Test, M
 
CO
 
starting line
alk with the 
ng the walk
uragement
ch time the
participan
he patient th
es to go.”  R
nds from co
o, just stop ri
his:  “Stop!”
d.  Mark the
he floor. 
s from the c
ance cove
al distance 
. 
on good ef
merican Tho
March 2002.
C
NFIDENTIAL
 
e.  You shou
patient.  As
k.  Use an e
.  Watch th
 participan
t see you d
he following
Repeat afte
ompletion sa
ight where 
”  Walk ove
e spot whe
counter. 
red using th
walked, rou
fort and off
oracic Socie
Clinical Inve
L 
uld also stan
s soon as th
even tone o
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nt returns to
do it.   
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er each min
ay this:  “In 
you are an
r to the pat
re they stop
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unding to t
fer a drink o
ety, ATS Sta
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Study No
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estigational 
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of voice wh
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e starting lin
starts to wa
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t distracted
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me to you.”
sider taking
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alk, 
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d and 
k the 
ng 
to 
 
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ean 
ce 
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or the 

 
 
 
 
 11 Nov 2
 
17.6 
Under ea
MOBILITY
I have no
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SELF-CA
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2014 
Quality o
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 11 Nov 2
 
PAIN / D
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2014 
DISCOMFOR
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 11 Nov 
 
17.7 
Copyrig
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1. Heart 
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2014 
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Version 7.0 
l Plan - VP0
Page 120 o
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Version 7.0 
l Plan - VP0
Page 121 o
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Page 122 o
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Version 7.0 
l Plan - VP0
Page 123 o
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Version 7.0 
l Plan - VP0
Page 124 o
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Version 7.0 
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Page 125 o
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PATIENT E
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artWare MV
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Version 7.0 
l Plan - VP0
Page 126 o
n  
Succe
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VAD®
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Final 
01223
of 153
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on 
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 11 Nov 
 
PATIENT E
Success
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PATIENT: 
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training cert
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C
NFIDENTIAL
Re
Pat
Init
te 
 
 
 
 
mpleted the
nd that all of
 
 
mpleted the
nd that all of
 
 
nt/caregiver
tification of t
 
 
Clinical Inve
L 
eview and De
tient 
tials 
Car
Initi
 
 
 
 
e above liste
f my questio
_______ _
(Date)
e above liste
f my questio
_______ _
(Date)
r has success
the MVAD® S
_________
(Date) 
Hea
Study No
V
estigationa
P
emonstration
regiver 
ials 
Edu
Initia
 
 
 
 
d requireme
ons have bee
_____________
d requireme
ons have bee
_____________
sfully comple
System. 
_____________
artWare MV
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Version 7.0 
l Plan - VP0
Page 127 o
n  
Succe
Demo
stratio
cator 
als 
Certif
Initial
Date
 
 
 
 
ents for hand
en answered
_________ 
ents for hand
en answered
_________ 
eted the ab
________ 
VAD®
AD-01 
Final 
01223
of 153
essful 
on- 
on 
fier 
s and 
ds-on 
d to 
ds-on 
d to 
ove 

 
 
 
 
 11 Nov 
 
17.8.3 B
Purpose
The pur
caregive
blood 
recomm
along w
pressure
Indicatio
All of the
with VAD
included
patient 
Other fa
able to 
included
Training 
Training 
discharg
must be
range v
using ha
them fo
have su
determi
friends w
subject's
 
2014 
lood Pressu
 
pose of bl
ers are train
pressure 
mendations 
with the site
e care.  
ons 
e clinical sit
Ds to home
d for the cl
and careg
amily mem
take an a
d in training
Requireme
the subjec
ge. To be 
e able to de
alues. In or
ands-on de
or home mo
ccessfully c
ne the ap
who live w
s new lifesty
ure Manage
ood pressu
ned on the
at 
home,
of the blo
e specific m
tes particip
e. Blood Pre
linical cent
giver/comp
bers and/o
active role 
g. 
ents for Disc
ct and car
eligible for
emonstrate
rder to eva
emonstratio
onitoring fo
completed 
ppropriaten
ith or near
yle with an 
 
 
CO
 
ement Train
ure manag
e BPC or BP
, 
after 
d
ood pressu
medical rec
pating in thi
essure Patie
ters. The ce
panion sho
or close frie
in the pat
charge 
regiver/com
r discharge
e proficienc
aluate their
ons with the
or the study
the “Hand
ess for dis
r the subjec
MVAD may
C
NFIDENTIAL
ning 
gement tra
PC/Dopple
discharge 
ure values 
commenda
s trial will h
ent Educati
enters are r
ould be tra
ends who liv
tient's new 
mpanion is 
e, both the
cy in BP ma
r understan
e blood pre
y. Once the
ds On” train
scharge. O
ct and are
y also be in
Clinical Inve
L 
ining is to 
r cuffs use 
from 
the
associated
ations for t
ave experi
ion and Ski
required to
ained toge
ve with or 
w lifestyle w
 essential f
e subject a
anagement
nding and 
essure/ dop
e subject a
ning, the PI/
Other family
e able to t
ncluded in t
Hea
Study No
V
estigationa
P
assure tha
for measur
e 
hospital.
d with the 
he subject
ence disch
ills Checklis
o use these 
ether in BP 
near the p
with an VAD
for a safe 
and caregiv
t and respo
ability, they
ppler devic
and caregiv
/VAD/Trans
y member
ake an ac
training. 
artWare MV
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Page 128 o
at subjects 
ring the sub
. 
 
Sugge
MVAD® Sy
t specific b
harging pat
t template
templates
managem
patient and
D may also
and succe
ver/compa
onding to o
y will be te
ces provide
ver/compa
splant Team
rs and/or c
ctive role in
VAD®
AD-01 
Final 
01223
of 153
and 
bject 
ested 
ystem 
blood 
tients 
s are 
. The 
ment. 
d are 
o be 
essful 
anion 
out of 
ested 
ed to 
anion 
m will 
close 
n the 

 
 
 
 
 11 Nov 
 
17.8.4 Sa
Patient / 
Educatio
Overview
devices 
Patient B
Manage
(frequen
expecte
etc) 
Review o
complet
responsi
Review w
emerge
who and
 
PATIENT &
PRESSURE
BLOOD P
State the
on the s
Success
cuff 
Success
ausculta
Success
used (fo
for subje
Success
measure
Success
inflation 
measure
Success
measure
Success
be reco
pressure
State ho
2014 
ample Bloo
Caregiver B
n and Skills C
w of  the Bl
and comp
Blood Press
ement Instru
ncy or mea
ed patient s
of the patie
tion at hom
bilities 
what is an e
ncy directio
d when to c
& CAREGIVE
E EDUCATION
PRESSURE C
e requireme
ame arm 
fully compl
fully identify
ation and D
fully identify
or subjects w
ects without
fully identify
ement 
fully identify
required fo
ement 
fully compl
ements 
fully identify
rded (systo
e or mean a
ow often to 
od Pressure 
lood Pressur
Certification
ood Pressu
ponents pro
ure 
uctions pro
asurements,
specific val
ent diary 
me and pat
emergency
ons, includi
call. 
R/COMPANI
N AND SKILLS
CUFF/DOPPL
ent to alwa
ete placem
y the pulse 
Doppler 
y the devic
with pulse u
t pulse use 
y the proce
y the amou
or accurate
ete 2 blood
y the meas
olic and dia
arterial pres
measure b
 
CO
 
Patient Edu
re  
n 
re 
ovided 
 
 
vided 
 
ues, 
 
ient 
 
y and 
ng 
 
ON BLOOD 
S CHECKLIST
LER 
ays place it 
ment of the
by 
ce to be 
use BP cuff, 
Doppler) 
edure for BP
unt of 
e BP 
d pressure 
urements t
stolic blood
sure) 
blood 
C
NFIDENTIAL
ucation and
Patient 
Initials 
Review 
Patient 
Initials
 
 
e 
 
 
 
P 
 
 
 
o 
d 
 
 
Clinical Inve
L 
d Skills Che
Caregiver 
Initials 
 
 
 
 
 
and Demon
Caregiver
Initials 
 
 
 
 
 
 
 
 
 
 
Hea
Study No
V
estigationa
P
ecklist 
Educato
Initials
 
 
 
 
nstration  
r 
Educator 
Initials 
 
 
 
 
 
 
 
 
 
 
artWare MV
o. HW-MVA
Version 7.0 
l Plan - VP0
Page 129 o
or 
 
Certi
Initials
Dat
 
 
 
 
Successful
Demonstra
Certifier In
and Date
 
 
 
 
 
 
 
 
 
 
VAD®
AD-01 
Final 
01223
of 153
ifier 
s and 
te 
l 
ation 
itials 

 
 
 
 
 11 Nov 
 
PATIENT &
PRESSURE
pressure
PATIENT 
State the
diary rec
State wh
complet
State wh
the patie
State ho
the diary
State wh
BP 
State wh
optimal
State wh
diary 
State wh
to stop r
State wh
diary at 
nurse 
Success
diary aft
OTHER 
 
PATIENT/C
My signa
training c
answered
_________
(Patient/
CERTIFIER
My signa
listed req
_________
(Certifier 
2014 
& CAREGIVE
E EDUCATION
e 
DIARY 
e importan
cording 
hen are you
ting the dia
hat is requir
ent diary 
ow often is r
y 
hat is the ta
hat you hav
hen do you
ho makes th
recording in
hat do you 
your follow
fully compl
ter taking th
CAREGIVER 
ture below i
certification 
d to my satis
____________
Caregiver si
R 
ture below i
quirements fo
____________
signature) 
R/COMPANI
N AND SKILLS
ce of the B
u expected
ary 
red to be c
required to 
arget/range
ve to do if B
u stop comp
he determi
n the diary 
have to do
w-up visit wit
ete 2 entrie
he BP 
ndicates tha
of the blood
sfaction. 
_____________
gnature)  
ndicates tha
or hands-on 
_____________
 
 
 
CO
 
ON BLOOD 
S CHECKLIST
BP patient 
d to start 
ompleted i
complete 
e of optima
BP is not 
pleting the 
nation whe
o with the 
th the study
es in the 
at I have com
d pressure m
________
at the patien
training cert
________
C
NFIDENTIAL
Review 
Patient 
Initials
 
 
 
in 
 
 
al 
 
 
 
en 
 
y 
 
 
 
 
mpleted the
anagement
 
 
nt/care give
tification of t
 
 
Clinical Inve
L 
and Demon
Caregiver
Initials 
 
 
 
 
 
 
 
 
 
 
 
 
 
e above liste
t and that al
 
_
 
(
r has succes
the blood pr
 
_
 
(
Hea
Study No
V
estigationa
P
nstration  
r 
Educator 
Initials 
 
 
 
 
 
 
 
 
 
 
 
 
 
d requireme
ll of my ques
_____________
Date) 
ssfully compl
ressure mana
_____________
Date) 
artWare MV
o. HW-MVA
Version 7.0 
l Plan - VP0
Page 130 o
Successful
Demonstra
Certifier In
and Date
 
 
 
 
 
 
 
 
 
 
 
 
 
ents for hand
stions have b
_________ 
leted the ab
agement. 
_________ 
VAD®
AD-01 
Final 
01223
of 153
l 
ation 
itials 
ds-on 
been 
bove 

 
 
 
 
 11 Nov 
 
17.9 
Adverse
be revise
Nationa
Registry 
HEMOLY
Minor He
lactate 
limits of t
implant 
function
Major He
lactate 
upper lim
hours po
abnorm
following
o H
o A
le
o H
c
o P
RIGHT H
Definitio
both of t
● D
● M
2014 
Adverse 
e event defi
ed accordi
l Institutes o
(INTERMAC
YSIS: 
emolysis:  A
dehydroge
the normal
in the abse
n. 
emolysis:  A
dehydroge
mits of the n
ost-implant 
al pump fu
g condition
Hemoglobin
Anemia (de
evels explai
Hyperbilirubi
component
ump malfu
EART FAILUR
on:  Sympto
the followin
Documenta
o Direc
centr
or  
o Findin
inspira
or 
o Clinic
the n
Manifestatio
o Clinic
or 
o Prese
(unm
Event Defi
initions con
ing to the p
of Health (N
CS Manual o
A plasma-fre
enase (LDH)
range at th
ence of clin
A plasma-fr
enase (LDH)
normal rang
and associ
nction. Ma
ns: 
nuria (“tea-c
crease in h
nable by c
inemia (tot
) 
nction and
RE: 
ms or findin
ng: 
ation of elev
t measurem
ral venous p
ngs of signif
atory variat
cal findings 
eck in an u
ons of eleva
cal findings 
ence of asc
istakable a
 
CO
 
initions  
ntinue to ev
published a
NIH) funded
of Operatio
ee hemogl
) level grea
he implanti
ical sympto
ree hemogl
) level grea
ge at the im
iated with c
ajor Hemoly
colored urin
hematocrit o
chronic illne
al bilirubin a
d/or abnorm
ngs of persis
vated centr
ment (e.g., 
pressure (CV
ficantly dila
tion by ech
of elevated
upright patie
ated centra
of peripher
ites or palp
abdominal c
C
NFIDENTIAL
volve.  The a
dverse eve
d Mechanic
ons Version 
obin value 
ater than tw
ing center o
oms or findi
lobin value
ater than tw
mplanting c
clinical sym
sis requires 
ne”) 
or hemoglo
ss or usual p
above 2 m
mal pump p
stent right v
ral venous 
right heart 
VP) or right
ated inferior
hocardiogra
d jugular ve
ent.  
al venous pr
ral edema 
pable hepa
contour) or
Clinical Inve
L 
adverse eve
ent definitio
cal Circulat
4.0; May 15
greater tha
wo and one
occurring a
ings of hem
e greater th
wo and one
center occu
ptoms or fin
the presen
obin level th
post-VAD st
g%, with pr
parameters
ventricular f
pressure (C
catheteriza
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r vena cava
aphy,  
enous diste
ressure cha
(>2+ either
atomegaly o
r by diagno
Hea
Study No
V
estigationa
P
ent definitio
ons as deter
ory Suppor
5, 2013).  
an 20 mg/d
e-half time (
after the firs
molysis or ab
an 20 mg/d
e-half times 
urring after 
ndings of h
nce of one o
hat is out of
tate) 
redominate
s  
failure char
CVP) by: 
ation) with 
sure (RAP) >
a with abse
nsion at lea
aracterized 
r new or unr
on physica
ostic imagin
artWare MV
o. HW-MVA
Version 7.0 
l Plan - VP0
Page 131 o
ons below m
rmined by t
rt Database
dl or a serum
(2.5x) the u
st 72 hours p
bnormal pu
dl or a serum
(2.5x) the 
the first 72 
emolysis or
or more of 
f proportion
ely indirect 
racterized b
evidence o
> 16 mmHg
ence of 
ast half way
by: 
resolved), 
l examinati
ng,  
VAD®
AD-01 
Final 
01223
of 153
may 
the 
e 
m 
pper 
post-
ump 
m 
r 
the 
n to 
by 
of a 
g. 
y up 
on 

 
 
 
 
 11 Nov 
 
IF the pa
failure w
(NOTE: F
measure
criteria)
VAD Imp
Patient m
●
   
●
Surveilla
following
Patient m
●
●
VAD Imp
Patient m
● P
b
Surveilla
following
Patient m
● Li
si
   
● N
 
2014 
or 
o Labo
dysfu
atient meet
will be grade
For right hea
ement of ce
plant Admis
meets both
 Post-imp
continue
            AND
 No inotro
ance period
g VAD impl
meets both
 No readm
               
 No inotro
plant Admis
meets both
ost-implant
beyond pos
ance period
g VAD impl
meets both
imited to on
nce last sur
        AND 
No inotrope
ratory evid
nction (cre
s the defini
ed accordi
art failure to
entral veno
Rig
ssion 
criteria for 
lant inotrop
ed beyond 
D 
opes contin
ds (3 month
lant 
criteria for 
missions for 
AND 
opes since l
ssion 
criteria for 
t inotropes,
t-op day 7 
ds (3 month
lant 
criteria for 
ne (1) read
rveillance p
s since last 
 
 
CO
 
ence of wo
eatinine > 2
tion for righ
ing to the fo
o meet seve
ous pressure
ght Heart Fa
Mild Rig
RHF plus: 
pes, inhaled
post-op da
nued beyon
hs, 6 months
RHF plus: 
RHF since l
ast surveilla
Moderate 
RHF plus: 
inhaled nit
and up to 
hs, 6 months
RHF plus: 
dmission for 
period 
surveillance
C
NFIDENTIAL
orsening he
.0). 
ht heart failu
ollowing sca
ere or seve
e or right atr
ailure Sever
ght Heart Fa
d nitric oxid
ay 7 followin
nd post-op 
s, 12 month
ast surveilla
ance period
Right Heart
tric oxide o
post-op da
s, 12 month
intravenou
e period 
Clinical Inve
L 
epatic (tota
ure, the sev
ale below.
ere acute se
rial pressure
rity Grade
ailure 
e or intrave
ng VAD imp
day 7 follow
hs and ever
ance period
d. 
t Failure 
r intraveno
ay 14 follow
hs and ever
us diuretics/
Hea
Study No
V
estigationa
P
al bilirubin > 
verity of the
everity, dire
e must be o
enous vaso
plant   
wing VAD i
ry 6 months
d   
us vasodila
wing VAD im
ry 6 months
/vasodilator
artWare MV
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Version 7.0 
l Plan - VP0
Page 132 o
 2.0) or rena
e right heart
ect 
one of the 
dilators not
mplant 
s thereafter)
ators contin
mplant 
s thereafter)
rs to treat R
VAD®
AD-01 
Final 
01223
of 153
al 
t 
t 
) 
ued 
) 
RHF 

 
 
 
 
 11 Nov 
 
VAD Imp
Patient m
● C
   
● P
c
Surveilla
following
Patie
● N
   
● Tw
si
   
● R
● D
R
VAD Imp
Patient m
● C
● N
● D
 
2014 
plant Admis
meets both
Central veno
       AND 
rolonged p
continued b
ance period
g VAD impl
ent meets b
Need for ino
        OR  
wo (2) or m
nce last sur
         OR 
equiring RV
OR 
Death at an
HF as the p
plant Admis
meets both
Central veno
AND 
Need for rig
OR 
Death during
ssion 
criteria for 
ous pressure
post-implan
beyond pos
ds (3 month
lant 
both criteria
otropes at a
more readm
rveillance p
VAD suppor
ny time follo
primary cau
Se
ssion 
criteria for 
ous pressure
ht ventricul
g the VAD 
 
 
CO
 
Severe Ri
RHF plus: 
e or right a
t inotropes,
st-op day 14
hs, 6 months
 for RHF plu
any time sin
missions for in
period 
rt at any tim
owing disch
use. 
evere-Acut
Right Heart
e or right a
ar assist de
implants ho
C
NFIDENTIAL
ight Heart F
trial pressur
, inhaled ni
4 following 
s, 12 month
us: 
nce last surv
ntravenous 
me after ho
arge from t
e Right Hea
t Failure plu
trial pressur
evice at any
ospitalizatio
Clinical Inve
L 
Failure 
re greater t
tric oxide o
VAD impla
hs and ever
veillance pe
diuretics/v
ospital disch
the VAD im
art Failure 
us: 
re greater t
y time follow
on with RHF 
Hea
Study No
V
estigationa
P
than 16mm
or intraveno
ant 
ry 6 months
eriod 
vasodilators
harge 
mplant hosp
than 16 mm
wing VAD i
as the prim
artWare MV
o. HW-MVA
Version 7.0 
l Plan - VP0
Page 133 o
 Hg 
ous vasodila
s thereafter)
s to treat RH
pitalization w
mHg 
mplant 
mary cause
VAD®
AD-01 
Final 
01223
of 153
ators 
) 
HF 
with 
. 

 
 
 
 
 11 Nov 
 
DEVICE M
A Device
operate
intended
Use. 
Device m
1. Majo
of th
induc
deat
Iatro
majo
a
b
c
d
e
f.
2. Mino
whic
does
exter
interc
Pump Th
delineat
thrombu
biochem
upon de
Doppler
in or cou
1. Susp
para
cann
criter
a
b
c
2014 
MALFUNCTI
e Malfuncti
e to its desig
d.  Perform
malfunction
or device m
e compone
ce a state o
th.  A failure
genic/Reci
or when  on
a. Suspecte
b. Urgent tr
c. Pump rep
d. Pump ex
e. Breach o
 Death 
or device m
ch require re
s not apply 
rnal contro
connecting
hrombus rep
ted as susp
us  will be c
mical, or he
evice inspe
r flow signa
uld potentia
ected pum
ameters sug
nulae, or gr
ria: 
a. Presence
b. Presence
c. Abnorma
ION: 
ion occurs w
gned perfor
ance spec
ns can be f
malfunction,
ents of the 
of inadequ
e that was i
ipient-Induc
ne of the fo
ed or confir
ransplantat
placement
xplant 
of integrity o
malfunction 
epair or rep
to “routine
ller, pneum
g cables. 
presents a s
pected pum
lassified as 
emodynami
ction or inc
ls that conf
ally induce 
mp thrombus
ggest throm
rafts.  Signs 
e of hemoly
e of heart fa
al pump pa
 
CO
 
when any c
rmance spe
ifications in
further defin
, otherwise 
MCSD syste
ate circula
atrogenic o
ced Failure
llowing con
rmed pump
ion (immed
t 
of drive line
includes ina
placement 
e” maintena
matic drive u
special cas
mp thrombu
“SUSPECTE
ic findings o
controvertib
firms thromb
circulatory
s is a pump
mbus on the
and sympt
ysis  
ailure not ex
arameters 
C
NFIDENTIAL
componen
ecifications
nclude all c
ned as maj
known as f
em either d
tory suppo
or recipient
.  A device
nditions occ
p  thrombus
diate 1A list
e that requir
adequately
but do not 
ance which
unit, electric
se of major 
s or confirm
D” (see def
or “CONFIR
ble radiolog
bus within t
y failure. 
p-related m
blood con
oms should
xplained by
Clinical Inve
L 
nt of the MC
s or otherwi
laims made
jor or minor
failure, occ
directly cau
rt (low card
t-induced w
e malfunctio
curs: 
s (see below
ing for tran
red repair
y functionin
result in 1a
h includes re
c power su
device ma
med pump t
finition belo
RMED” (see 
gic studies o
the device 
malfunction 
ntacting co
d include at
y structural
Hea
Study No
V
estigationa
P
CSD system 
ise fails to p
e in the Inst
r: 
urs when o
uses or could
diac output
will be class
on or failure
w) 
splant) 
ng external
a-f.  Device 
epair/repla
pplies, batt
alfunction a
thrombus.  
ow) based 
definition b
or absence
or its condu
in which cl
omponents 
t least 2 of t
l heart disea
artWare MV
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Version 7.0 
l Plan - VP0
Page 134 o
ceases to 
perform as 
tructions for
f one or mo
d potential
t state) or 
sified as an 
e is conside
 componen
malfunctio
acement of
teries and 
and can be
Pump 
upon clinic
below) bas
e of approp
uits that res
inical or MC
of the pum
the 3 follow
ase  
VAD®
AD-01 
Final 
01223
of 153
r 
ore 
ly 
red 
nts 
on 
f:  
e 
cal, 
ed 
priate 
sults 
CSD 
mp, 
wing 

 
 
 
 
 11 Nov 
 
Susp
even
v
2. Conf
is co
outflo
incon
appr
failur
If a Susp
following
the even
Thrombu
MAJOR 
An episo
of the fo
 
a
 
b
 
c
 
d
 
 
If 
D
 
 
 
 
 
 
 
 
 
 
 
2014 
ected pum
nts or interve
i. 
treatm
throm
eptifib
ii. 
pump
iii. 
pump
iv. 
urgen
v. 
stroke
vi. 
arteri
vii. 
death
firmed pum
nfirmed wit
ow conduit
ntrovertible
ropriate Do
re or result i
pected Pum
g pump rep
nt will be ad
us. 
BLEEDING: 
ode of SUSP
ollowing: 
a. Death, 
b. Re-opera
c. Hospitaliza
d. Transfusio
transfusion
During first 7
 ≥ 50
hour 
 < 50
any 2
mp thrombu
entions:     
ment with in
mbolytics  (e
batide, tiro
p replacem
p explantat
nt transplan
e 
al non-CNS
h 
mp thrombus
thin the blo
t or grafts.  
e contrast ra
oppler flow 
n thromboe
mp Thrombu
placement,
djudicated
PECTED INTE
tion, 
ation, 
n of red blo
n is selected
days post 
0 kg:  ≥ 4U p
period duri
0 kg:  ≥ 20 c
24 hour peri
 
 
CO
 
us should be
ntravenous
e.g., tPA), o
fiban) 
ment 
tion 
ntation (UNO
S thromboe
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od contac
This can be
adiographi
signal that 
embolism.
us event is u
, urgent tra
 by the CEC
ERNAL OR E
ood cells as
d, then app
implant 
packed red
ng first 7 da
cc/kg pack
iod during f
C
NFIDENTIAL
e accompa
s anticoagu
or intraveno
OS status 1A
embolism  
r pump-rela
ting surface
e reported v
c evidence
results in or
ultimately c
nsplantatio
C for reclas
EXTERNAL B
s follows: 
ply the follow
d blood cell
ays post imp
ed red bloo
first 7 days p
Clinical Inve
L 
anied by 1 o
ulation (e.g
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A) 
ated malfun
es of devic
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e or by the 
r could pote
onfirmed th
on or upon 
ssification to
LEEDING th
wing rules: 
s (PRBC) w
plant. 
od cells (PR
post implan
Hea
Study No
V
estigationa
P
or more of 
., heparin),
elet therap
nction in wh
e inflow ca
visual inspec
absence o
entially indu
hrough visu
autopsy fol
o Confirme
hat results in
 
ithin any 24
RBC) within 
nt. 
 
artWare MV
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the followin
 intravenou
py (e.g., 
hich thromb
annula or 
ction or by 
of  an 
uce circula
ual inspectio
llowing dea
d Pump 
n one or mo
4   
  
VAD®
AD-01 
Final 
01223
of 153
ng 
us 
bus 
atory 
on 
ath, 
ore 

 
 
 
 
 11 Nov 
 
After 7 d
Note:  H
bleeding
MAJOR 
A clinica
treated 
infected
need fo
listed be
Localize
Infection
of system
method
infection
Percutan
A positiv
surround
the nee
infection
Internal 
Infection
culture. 
infection
Sepsis 
Evidenc
and/or h
 
2014 
days post im
 A tra
impla
numb
emorrhagic
g event. 
INFECTION:
al infection 
by anti-mic
d site or org
r treatment
elow:  
ed Non-Dev
n localized 
mic involve
s and eithe
n, and/or re
neous Site a
ve culture fr
ding the ext
d to treat w
n such as p
Pump Com
n of blood-c
 (There sho
n at the pe
e of system
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ansfusion o
ant with the
ber of units 
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: 
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t despite ne
 
 
vice Infectio
to any orga
ment (see s
er associate
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and/or Poc
rom the skin
ternal hous
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ain, fever, d
mponent, Inf
contacting
ould be a se
rcutaneous
mic involvem
n. 
 
 
CO
 
of packed re
e investigato
given per 2
considered 
nied by pai
ents (non-pr
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egative cul
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mpirical trea
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crobial thera
drainage, o
flow or Outf
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eparate da
s cannula s
ment by infe
C
NFIDENTIAL
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or recording
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in, fever, dr
rophylactic
unless stron
tures.  The g
 
 
or region (e
nition), asce
dence of ba
atment.  
on 
sue surroun
mp implan
apy, when 
or leukocyto
flow Tract In
of the LVAD
ta field for 
ite, e.g. Tho
ection, man
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cells (PRBC) 
g the numb
riod). 
gical event 
rainage an
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general ca
 
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ertained by
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nted within t
there is clin
osis. 
nfection 
 document
paracorpo
oratec PVA
nifested by
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estigationa
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after 7 day
ber of units 
and not as
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ral, fungal o
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nical eviden
ted by posi
oreal pump 
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y positive bl
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Version 7.0 
l Plan - VP0
Page 136 o
ys following
given.  (rec
s a separate
cytosis that
rom the 
ndicates th
f infection a
out evidenc
clinical 
or protozoa
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coupled wit
nce of 
itive site 
that descr
ood culture
VAD®
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Final 
01223
of 153
g 
cord 
e 
 is 
e 
are 
ce 
l 
ssue 
th 
ibes 
es 

 
 
 
 
 11 Nov 
 
NEUROLO
Any new
by a sta
other qu
consulta
examinin
or as a n
by a clin
activity, 
neurolog
neurolog
 
a
b
c
d
e
f.
 
2014 
OGICAL DY
w, tempora
ndard neur
ualified phy
ation note; 
ng physicia
non-vascula
nically evide
or as a clin
gic event sh
gic assessm
a. Transient
conform
resolves i
(head CT
b. Ischemic
encepha
associate
the clinic
distributio
c. Acute sy
neurolog
months**
be speci
intravent
d. Clinically
imaging,
recogniti
e. Hypoxic-
hypoxic-
or subclin
diagnost
ischemic
defined a
 Acute ne
evident s
complet
than stro
encepha
found to 
metabol
YSFUNCTION
ry or perma
rological hi
ysician and 
or an abno
an will classi
ar acute ne
ent sign or s
nically silent
hould be c
ment as one
t ischemic a
ing anatom
in < 24 hour
T performed
c stroke, def
alopathy or
ed with acu
cal deficit. I
on ischemia
ymptomatic
gic deficit (o
*) attributab
fied as one
tricular, par
y covert isch
, without cli
ion. 
-Ischemic E
ischemic in
nical electr
tic evaluatio
c brain injury
above. 
ew enceph
signs or sym
e neurolog
oke, ICH or H
alopathy in
be attribut
ic or drug-r
 
CO
 
N: 
anent, foca
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document
ormality ide
ify the even
eurologic ev
symptom, o
t lesion dete
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e of the follo
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mically to ar
rs and is ass
d >24 hours
fined as a n
r seizures in 
ute infarctio
schemic str
a or due to 
c intracrania
or acute en
ble to Intrac
e or a comb
renchymal,
hemic strok
inical findin
ncephalop
njury (HIE), m
rographic se
on to be at
y not meeti
halopathy**
mptoms or s
ical diagno
HIE, as defin
cludes neu
table to oth
related pro
C
NFIDENTIAL
al or global 
examination
ted with ap
ntified by s
nt as a cere
vent.  A ne
or by clinica
ected by su
the clinica
owing even
ined as an 
rterial distrib
sociated w
s after symp
new acute 
children <6
on on imag
roke should
venous thr
al hemorrha
ncephalopa
cranial hem
bination of 
 subdural.
ke or ICH: in
ngs of stroke
pathy: Acut
manifest as 
eizures foun
ttributable t
ing one of i
**  due to o
ubclinical e
ostic evalua
ned above
urologic sign
her conditio
cesses. 
Clinical Inve
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neurologic
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ebrovascula
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ally-silent el
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al provider f
nt types: 
acute tran
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with no infar
ptom onset
neurologic
6 months**)
ging corresp
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rombosis. 
age, define
athy or seiz
morrhage (I
the followin
nfarction or
e or ICH at 
te new enc
clinically- e
nd by com
to acute gl
ischemic st
other cause
electrograp
ation to be 
e. This categ
ns or sympt
ons such as
Hea
Study No
V
estigationa
P
c dysfunctio
ered by a n
diagnostic t
e neuroimag
ar event as
vent may b
lectrograph
neuroimag
following co
sient neuro
ebral ischem
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t; or MRI*). 
c deficit (or 
) of any dur
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assified as d
ed as new a
zures in child
ICH). ICH su
ng types: su
r ICH seen b
the time of
cephalopat
evident sign
plete neuro
lobal or foc
troke or ICH
es, manifest 
phic seizure
attributabl
gory of "oth
oms or sub
s meningitis
artWare MV
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on ascertain
eurologist o
tests and 
ging. The 
s defined b
be recogniz
hic seizure 
ging. Each 
omplete 
ologic defic
mia, which 
rain imaging
acute 
ration 
natomically
due to arte
acute 
dren < 6 
ubtype shou
ubarachno
by surveillan
f event 
thy*** due t
ns or sympt
ological 
cal hypoxic
H events as 
as clinicall
es found by 
e causes o
er" acute 
clinical seiz
, toxic-
VAD®
AD-01 
Final 
01223
of 153
ned 
or 
elow 
ed 
cit 
g 
y to 
rial-
uld 
id, 
nce 
to 
oms, 
 or 
y-
other 
zures 

 
 
 
 
 11 Nov 
 
*** Acut
and is m
or multif
function
CARDIA
Any doc
function
angina, 
cardiove
ablation
PERCAR
Accumu
or percu
clinical s
cardiac
MYOCA
Two cat
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Th
1
V
in
a
c
a
N
Th
 
   
2014 
 
e encepha
manifest as d
ocal neuro
n. 
C ARRHYTH
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ersion, ICD 
n procedure
1) Susta
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2) Susta
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DIAL FLUID 
ulation of flu
utaneous ca
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RDIAL INFA
egories of m
eri-Operati
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0 times the 
VAD implan
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apical corin
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alopathy is a
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ologic defic
HMIAS: 
arrhythmia 
nished VAD
or requires 
therapy (e
e).  Cardiac
ined ventric
ring hospita
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ined suprav
ring hospita
thmia abla
COLLECTIO
uid or clot i
atheter dra
mponade (e
ut) and tho
ARCTION: 
myocardia
ive Myocar
suspicion of
local hosp
t together w
This definitio
g at the tim
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es.)  
erative Myo
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hest pain w
 
CO
 
a sign or sy
consciousn
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D flow or su
hospitaliza
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ventricular 
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ON: 
n the peric
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l infarction 
rdial Infarct
f myocardi
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with ECG fi
on uses the 
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apical sew
ocardial Infa
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NFIDENTIAL
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ness with or 
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ction even
tion or trea
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thmia result
drug treatm
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arrhythmia
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will be iden
tion 
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imits of norm
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Clinical Inve
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 venous pre
mponade.
ntified: 
 
n together 
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gested limit
t, and does
herently cre
o of the foll
of myocard
Hea
Study No
V
estigationa
P
erlying cere
ny associate
ry, reflexes a
se (e.g., ab
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n clinical co
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ded into th
essure and 
 
with CK-MB
 within 7 da
h acute myo
t for serum 
s not use wa
eates new w
owing thre
dial ischemi
artWare MV
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l Plan - VP0
Page 138 o
bral disorde
ed new glo
and cerebe
normal VA
ope or sync
defibrillatio
rrhythmia 
omise, or 
ardioversion
ompromise,
CD therapy
al intervent
hose with 
decreased
 
B or Tropon
ays followin
ocardial 
markers du
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wall motion
e criteria:  
a,  
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Final 
01223
of 153
er, 
obal 
ellar 
D 
ope, 
on, 
n, 
, or 
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in > 
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ue to 
 

 
 
 
 
 11 Nov 
 
   
a
   
PSYCHIA
Disturba
function
addition
professio
RESPIRAT
Impairm
to disco
exclude
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VENOUS
Evidenc
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1
 
2
 
3
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OTHER S
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HEPATIC
 
An incre
aspartat
2014 
  
b) EC
and  
   
c) Tro
medi
with p
a new
imag
ATRIC EPISO
ance in thin
ning or mark
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onal for trea
TORY FAILU
ment of resp
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DEHISCENC
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te systemic 
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nition exclu
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nt that caus
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ease in any 
te aminotra
CG with a p
oponin or C
cine metho
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w regional L
ing study. 
ODE: 
king, emoti
ked subject
ychiatric m
atment.  Su
RE: 
iratory func
tilatory supp
n for re-ope
dures. 
 
EMBOLISM:
us thromboe
dard clinica
CE: 
pposed surf
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S THROMBO
arterial per
mbolism con
clinical and
e findings 
indings 
udes neurol
ses clinically
TION: 
two of the 
ansferase/A
 
CO
 
attern or ch
K (measure
ods) greate
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medication, 
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: 
embolic ev
al and labo
faces of a s
OEMBOLISM
rfusion defic
nfirmed by o
d laborator
ogical eve
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following h
AST and ala
C
NFIDENTIAL
hanges con
ed by stand
er than the n
3% total C
all motion a
avior that ca
s and requir
hospitaliza
uded in thi
ing reintuba
six days (14
emporary in
ent (e.g. de
oratory testin
surgical inc
: 
cit in any n
one or mor
ry testing 
 
 
nts. 
changes in 
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anine amino
Clinical Inve
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nsistent with
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44 hours) po
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eep vein th
ng. 
cision, exclu
on-cerebro
re of the fol
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boratory val
otranfereas
Hea
Study No
V
estigationa
P
h a myoca
al patholog
ge for the l
uld be acc
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tantial impa
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erral to a m
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heostomy o
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or diagnost
hrombosis, p
uding infect
ovascular o
llowing:  
nt’s health (
lues (total b
se/ALT) to a
artWare MV
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l Plan - VP0
Page 139 o
rdial infarct
y/laborato
ocal hospit
companied 
cardial 
airment in 
vention is th
mental healt
or the inabil
plant. This 
tic or 
pulmonary 
tious etiolog
organ system
e.g. cance
bilirubin, 
a level grea
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Final 
01223
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tion, 
ry 
tal 
by 
he 
th 
lity 
gy, 
m 
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ater 

 
 
 
 
 11 Nov 
 
than thre
(or if hep
HYPERTE
New ons
mm Hg d
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greater t
therapy 
discontin
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2014 
ee times th
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NSION: 
set blood p
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CS: Hyperte
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who did not
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An increase 
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nction is the
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ension is de
5th percenti
ement. The
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han 3 times
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nal Dysfunct
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mit of norma
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ile for age w
e event sha
ent. 
nction will b
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baseline o
pper limit of
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reatinine of
dialysis susta
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NFIDENTIAL
al for the ho
cause of de
ater  than o
mm Hg me
ystolic, diast
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ll be consid
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ained for at
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or equal to 
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uires the add
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including h
mplant, or a
han 5 mg/d
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r greater a
t least 90 da
Hea
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estigationa
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yond 14 day
140 mm Hg
e (rotary pu
ean blood p
dition of a n
ved upon t
emofiltratio
a rise in seru
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ained for ov
bove base
ays. 
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o. HW-MVA
Version 7.0 
l Plan - VP0
Page 140 o
ys post-imp
g systolic or
ump).    
pressure 
new IV or o
the 
on) in patie
um creatinin
ren, creatin
ver 48 hours
line, or 
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Final 
01223
of 153
plant  
r  90 
oral 
nts 
ne 
ine 
s. 

 
 
 
 
 11 Nov 
 
17.10
Please n
HeartWa
The infec
Long, M
Hospital
Francisc
(used w
HeartWa
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 
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 
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u
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e
c
8) Prior t
Vanc
2014 
0 Infection
note that the
are Investig
ction contr
D (LDS Hosp
, San Diego
co, CA), on 
ith permissio
are MVAD®
erative  
der risk fac
stablished o
Co-morbidit
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rolonged in
ove unnece
nister antim
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perative  
ating Room
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crubs, shoe
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Consider usi
nit to recyc
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are skin with
valent, whic
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r LVAD afte
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utaneous le
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omycin 2 g
 Control G
ese guideli
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ol guideline
pital, Salt La
o, CA), and
behalf of t
on) will iden
® clinical tria
tors for dev
or suspecte
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olled diabe
ntubation  
essary IV line
microbial pro
vity profile w
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m (OR) Prec
must wash h
e covers and
ic through O
ng OR air u
cle ambien
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ch is allowe
terile LVAD
er it has bee
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r velour.  
ad manag
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m costal ma
in. 
gate all surf
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Guidelines
nes will be 
possibly rev
es for the pr
ake City, UT
d Soon Park
he REMATC
ntify the inf
al.  
veloping de
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etes  
es and repl
ophylaxis b
with sufficie
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th antiseptic
autions:  
hands and 
d headgea
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t air.  
aneous tub
 scrub, alco
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 compone
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n into the ex
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nel the drive
argin to fit b
faces with a
Gentamicin
C
NFIDENTIAL
reviewed t
vised accor
revention o
T), Walter D
, MD (Pacif
CH Trial Surg
ection con
evice infect
ns  
dysfunction
ace old IV 
based on th
ent coverag
erococcus. 
c the night 
arms with a
ar that cove
trict openin
g system at 
be position 
ohol (allow 
nd drape p
nts premat
prior to impl
xternal surfa
eline lead t
ody habitu
antibiotic so
n 160 mg/L 
Clinical Inve
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throughout 
rding to pat
of infection 
Dembitsky, M
fic Californi
gical Workin
trol measur
tions, such 
n or immun
lines 12-24 
e hospital’s
ge for staph
 
before and
antimicrobi
ers all hair. 
ng of the do
air inlet or 
to minimize
to dry), the
patient.  
urely.  
ant.  
ace of the 
to the point
us and prev
olution prio
 NS).  
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estigationa
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the study b
tient experi
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MD (Sharp M
a Medical 
ng Group. T
re to be use
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nosuppressio
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s nosocomi
hylococcus
d again the
ial soap an
oor.  
portable H
e trauma to
en betadine
percutaneo
t of exit. Ad
vent rubbing
or to closing
artWare MV
o. HW-MVA
Version 7.0 
l Plan - VP0
Page 141 o
by the 
ience.  
oped by Ja
Memorial 
Center, Sa
The guidelin
ed for the 
on  
op.  
ial and 
s aureus, 
e morning o
d wear fres
EPA filtratio
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e gel or 
ous tube’s 
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g (e.g. 
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01223
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ames 
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nes 
of 
sh 
on 
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 11 Nov 
 
9) Consi
Postope
1) Conti
2) After 
cover
draina
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. Inappropr
ith a HeartW
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7.0 APP
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Table 1. 
 
 
2014 
PENDIX: D
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8 
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DATA COLL
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Version 7.0 
l Plan - VP0
Page 153 o
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