A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation, Atrial Fibrillation
Sponsor: Medtronic Cardiac Ablation Solutions

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DIAMOND-AF STUDY 
Study Title: A Randomized Controlled Clinical Evaluation of the DiamondTemp™ System for 
the Treatment of Paroxysmal Atrial Fibrillation 
 
Sponsor: 
  
 
Advanced Cardiac Therapeutics (ACT) 
 
 
 
 
2880 Lakeside Drive, Suite 250 
 
 
 
 
Santa Clara, CA 95054 USA 
 
 
 
 
+1 (408) 755-1500 
Protocol No:  
 
TP00599 
Investigational Device: 
DiamondTemp Ablation System  
(Inclusive of the DiamondTemp Ablation Catheter, DiamondTemp 
Catheter-to-RFG Cable, DiamondTemp GenConnect Cable, 
DiamondTemp RF Generator, DiamondTemp Irrigation Pump and 
DiamondTemp Irrigation Tubing Set) 
Revision Number: 
 
C 
Effective Date: 
 
08/31/2017  
 
 
 
 
 

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1. STUDY CONTACT INFORMATION 
Sponsor Contacts 
Bryan Wylie  
Director, Clinical Affairs (US) 
 
 
Jean Maurice Dussartre, M.D. 
Director, Clinical Affairs (EU) 
 
 
 
Patty Hevey 
Vice President, Clinical Affairs 
 
 
 
Coordinating Principal 
Investigators, US 
Tom McElderry, MD, FACC, FHRS 
Section Chief, Cardiac Electrophysiology 
 
 
 
William Maddox, M.D., FACC, FHRS 
Assistant Professor, Electrophysiology 
 
 
 
University of Alabama Birmingham (UAB) 
930B Faculty Office Tower 
510 20th Street South 
Birmingham, AL 35294 
 
Coordinating Principal 
Investigator, OUS 
Josef Kautzner, MUDr., CSc., FESC 
Director, Electrophysiology 
Institut klinické a experimentální medicíny (IKEM) 
Vitebsk 1958/9 
140 21 Prague 4 
 
 
 
 
 

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Steering Committee 
Including Coordinating 
Principal Investigators 
Andrea Natale, M.D., FACC, FHRS  
Director, Electrophysiology 
Texas Cardiac Arrhythmia Institute at St. David’s Medical Center 
 
 
Frank Cuoco, M.D., MBA 
Director, Electrophysiology 
Medical University of South Carolina (MUSC) 
 
 
OUS Contract Research 
Organizations (CRO) 
High Tech Med Consult 
Firmlova 1322/4e 
15500 Prague 5, Czech Republic 
Phone: +402 777 671 069 
 
 
 
MERC srl 
Via Elia Capriolo, 41 
25122 Brescia, Italy 
Phone: +39 030 2754021 
 
 
 
 
Data Management / 
Biostatistics 
Advanced Research Associates 
Data Management / Biostatistics 
2350 Mission College Blvd., Suite 825 
Santa Clara, CA 94054 
Phone: +1 (650) 810-1190 
 
 
Electronic Data 
Capture (EDC) 
Medrio 
345 California Street, Suite 325 
San Francisco, CA 94104 
Phone:  +1 (415) 963-3700 
 
ECG Core Lab 
HeartcoR Solutions, LLC 
Event Monitor, ECG Core Lab 
2403 Harnish Drive #201 
Algonquin, IL 60102  
Project Manager: Madalina Andreescu, BS, CRA, CCT 
Phone: +1 (224) 333-3318 
 
 

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Investigator Protocol Signature Page and Agreement 
I have read this Investigational Plan and agree to adhere to the requirements.  I will share 
this Investigational Plan and all pertinent information to all site personnel involved in this 
study.  I will discuss this material with them and ensure they are fully informed regarding 
the study products and the conduct of the study. 
I agree to conduct the study as outlined in the Investigational Plan, in accordance with the 
signed clinical study agreement and to the ethical principles stated in the latest version of 
the Declaration of Helsinki (2013), the applicable guidelines for good clinical practices, 
MEDDEV 2.7/4 (Guidelines on Clinical investigations: A Guide for Manufacturers and 
Notified Bodies) and 2.7/3 (Clinical investigations: Serious Adverse Event reporting), ISO 
14155:2011 (Clinical Investigation of Medical Devices for Human Subjects – Good 
Clinical Practice) or the applicable local and international regulations, whichever provide 
the greater protection of the individual.   
I agree to provide all the information requested in the Case Report Forms presented to me 
by the Sponsor in a manner to assure completeness, legibility and accuracy.  I agree to 
actively enroll patients into this study. 
I also agree that all information provided to me by the Sponsor, including pre-clinical data, 
protocols, Case Report Forms, and any verbal and written information, will be kept strictly 
confidential and confined to the clinical personnel involved in conducting the study. It is 
recognized that this information may be relayed in confidence to the Institutional Review 
Board / Ethics Committee.   
In addition, no reports or information about the study or its progress will be provided to 
anyone not involved in the study other than the Sponsor, the Institutional Review Board / 
Ethics Committee, the core labs, or the Data Safety Monitoring Board.  Any such 
submission will indicate that the material is confidential. 
 
 
 
 
 
Investigator Signature 
 
Date 
 
 
 
 
 
Investigator Printed Name 
 
Date 
 
 
 
 
 
 
 
Sponsor Signature 
 
Date 
 
 
 
 
 
Sponsor Printed Name 
 
Date 
 
 

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2. REVISION HISTORY 
Revision 
Level 
DCO 
Description of Change 
Reason for Change 
Effective 
Date 
A 
0426 
Initial Release 
N/A 
08/25/2017 
B 
0429 
a. Update section 7.1, Proposed 
Intended Use of the 
Investigational Device to 
include: accessories 
(DiamondTemp Cable-to-
RFG Cable, DiamondTemp 
GenConnect Cable, 
DiamondTemp Irrigation 
Pump/Tubing Set); removed 
ablation, RF, and three 
dimensional descriptors.  
b. Update SAE rates for 7 and 
30 day follow up 
a. Clarification of 
statement; no change 
to intent. 
b. Reflects updated 
results. 
08/29/2017 
C 
0438 
Updated Table 4, Summary of 
Procedural Data, in Section 5. 
Reflects updated results.  08/31/2017 
 
 

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3. PROTOCOL SUMMARY 
Objective 
The objective of this study is to demonstrate the safety and effectiveness 
of the DiamondTemp Ablation System for the treatment of drug 
refractory, recurrent, symptomatic paroxysmal atrial fibrillation. 
Test Device 
DiamondTemp Ablation System consists of: 
• DiamondTemp Ablation Catheter  
• DiamondTemp Catheter-to RFG Cable  
• DiamondTemp GenConnect Cable  
• DiamondTemp Generator with Footswitch  
• DiamondTemp Irrigation Pump  
• DiamondTemp Irrigation Tubing Set  
The investigational device will be used with commonly available: 
• EP recording systems 
• Cardiac stimulators 
• EnSite™ Velocity™ or Precision™ Cardiac Mapping System  
Control Device 
 
St. Jude Medical (Abbott) Ablation System 
o TactiCath™ Quartz Contact Force Ablation Catheter   
o AMPERE™ RF Ablation Generator and Cables or equivalent 
o COOL POINT™ Irrigation Pump and Tubing or equivalent 
The control device will be used with commonly available: 
• EP Recording Systems 
• Cardiac Stimulators 
• EnSite™ Velocity™ or Precision™ Cardiac Mapping System 
Study Design 
The DIAMOND-AF study is a prospective, single-blind, 1:1 
randomized, controlled trial being performed at multiple centers in the 
United States, Canada and Europe. 
Planned Subject 
Sample Size 
A maximum of 350 subjects will be enrolled and randomized in this 
study. 
Planned Number of 
Global 
Investigational Sites 
Subjects will be enrolled at up to 30 investigational sites in the United 
States (US) and outside of the US (OUS). 
A minimum of 50% of the data will be generated from sites within the 
US. 
Ablation Procedure 
The primary focus of the ablation procedure is to create a series of point-
by-point radiofrequency (RF) lesions encircling the left and right PVs to 
achieve electrical pulmonary vein isolation (PVI) from the rest of the 
left atrium (LA).  

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Investigators may use their preferred approach to obtain PVI, such as 
antral or wide area circumferential ablation (WACA) targeting PVs 
individually or PV pairs ipsilaterally.   
PVI must be confirmed by entrance block at least 20 minutes following 
the last ablation around the respective PV.   Targeting non-PV foci and 
complex fractionated electrograms (CFAE) is not recommended in this 
investigation.  If the investigator identifies additional focal or macro-
reentrant atrial sites to be clinically relevant to AF and requiring 
ablation, the ablation location will be documented. 
Primary Safety 
Endpoint 
The primary safety endpoint is defined as freedom from a composite of 
serious adverse events (SAE) occurring within 7-days post-index 
ablation procedure or hospital discharge, whichever occurs later, as 
adjudicated by an independent Clinical Events Committee (CEC) for 
relatedness to the procedure or device.  
The primary safety device- or procedure-related SAEs composite will be 
the combined rate of the following events:     
• Atrioesophageal fistula  
• Cardiac tamponade / perforation  
• Cardiovascular-related death post-ablation 
• Bleeding complication  
• Myocardial infarction  
• Pericarditis  
• Phrenic nerve paralysis 
• Pulmonary edema 
• Stroke or transient ischemic attack (TIA)    
• Thromboembolism 
• Vagal nerve injury  
• Vascular access complications  

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Primary 
Effectiveness 
Endpoint 
The primary effectiveness endpoint is defined as freedom from 
documented symptomatic atrial fibrillation (AF) episodes following the 
blanking period (3-month follow-up post-ablation procedure) through 
the end of the effectiveness evaluation period (12-month follow-up post-
ablation procedure).  
An effectiveness failure is defined by any of the following events during 
the effectiveness evaluation period (3-month through 12-month follow-
up visits post ablation): 
• Documented episodes of AF lasting ≥ 30 seconds in duration as 
evidenced by electrocardiographic data   
• A repeat ablation procedure to treat AF   
• Use of a new or modification to existing Class I-IV anti-
arrhythmic drug (AAD) regimen to treat AF recurrence   
Secondary Endpoints 
Secondary endpoints to characterize the performance of the 
DiamondTemp Ablation System, relative to the control device, will 
include: 
• Freedom from a composite of SAE occurring within 30-days 
post-index ablation procedure as adjudicated by an independent 
CEC for relatedness to the procedure or device.  
• Freedom from documented symptomatic and asymptomatic atrial 
tachycardia (AT) and atrial flutter (AFL)* episodes following the 
blanking period through 12-month follow-up post-ablation 
procedure. 
• Freedom from documented asymptomatic AF episodes through 
the effectiveness evaluation period lasting ≥ 30 seconds in 
duration by electrocardiogram (ECG) or ECG monitoring 
system. 
• Rate of acute procedural success, defined as confirmation of 
electrical isolation of PVs via assessment of entrance block at 
least 20 minutes following the last ablation around the respective 
PV.    
• Rate of occurrence of electrically reconnected PVs following a 
20-minute waiting period assessed by entrance block at index 
procedure.  
• Accumulated changes in QOL using the AF QOL Survey 
(AFEQT Questionnaire) from baseline through 6 and 12 months 
following ablation procedure. 
• Neurological changes measured using the NIH stroke scale 
between baseline and post-ablation (pre-discharge visit) and at 
12 months post-ablation procedure. 

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• Total procedure time (minutes), defined as time of first assigned 
ablation catheter insertion into the vasculature to time of last 
procedural ablation catheter removed. 
• Time to achieve initial PVI at index procedure (minutes), defined 
as time of delivery of first RF ablation with the assigned ablation 
catheter until confirmation of PVI. 
• Total treatment device time (minutes), defined as time of 
delivery of first RF ablation with the assigned ablation treatment 
catheter to removal of the treatment catheter. 
• Mean cumulative RF time (minutes).     
• Mean duration of RF ablations (seconds). 
• Total number of RF ablations per procedure.  
• Total fluid infused through the assigned ablation catheter (mL). 
• Total fluoroscopy time (minutes). 
• Number of re-hospitalizations due to atrial fibrillation recurrence 
after blanking period. 
*Occurrence and/or ablation of cavotricuspid isthmus (CTI)-dependent AFL, 
as confirmed by entrainment maneuvers during EP testing at any time during 
this study is not a primary effectiveness failure because it is not considered an 
iatrogenic arrhythmia following a left atrial ablation procedure for AF.    
Inclusion Criteria 
1. Above eighteen (18) years of age or of legal age to give 
informed consent specific to state and national law.   
2. Patients with a history of symptomatic, paroxysmal atrial 
fibrillation (PAF) who have had ≥ 2 episodes of PAF reported 
within the 12 months prior to index ablation procedure. 
3. At least one episode of PAF ≥ 30 seconds in duration 
documented by electrocardiographic data.  
4. Failure or intolerance of at least one Class I-IV anti-arrhythmic 
AAD for treatment of PAF.  
5. Suitable candidate for intra-cardiac mapping and ablation of 
arrhythmia. 
6. Patient agrees to comply with study procedures and be available 
(geographically stable) for follow-up visits for at least 12 months 
after enrollment. 
7. Patient is willing and able to provide written consent.  

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Exclusion Criteria 
At time of enrollment and/or prior to procedure: 
1. AF secondary to electrolyte imbalance, thyroid disease or 
reversible or non-cardiac cause. 
2. LA diameter > 5.5 cm. 
3. Left ventricular ejection fraction (LVEF) < 35%. 
4. Currently NYHA Class III or IV or exhibits uncontrolled heart 
failure. 
5. Body Mass Index (BMI) > 40 kg/m2. 
6. LA ablation, septal closure device or mitral valve surgical 
procedure at any time prior to enrollment. 
7. Presence of intramural thrombus, tumor or abnormality that 
precludes vascular access, catheter introduction or manipulation. 
8. Coagulopathy, bleeding diathesis or suspected procoagulant state 
9. Sepsis, active systemic infection or fever (>100.5 oF / 38 oC) 
within a week prior to the ablation procedure. 
10. Significant restrictive or obstructive pulmonary disease or 
chronic respiratory condition. 
11. Renal failure requiring dialysis or renal compromise that in the 
investigator’s judgement would increase risk to the patient or 
deem the patient inappropriate to participate in the study. 
12. Known allergies or intolerance to anticoagulant and antiplatelet 
therapies to be used in conjunction with the study or contrast 
sensitivity that cannot be adequately pre-treated prior to the 
ablation procedure. 
13. Positive pregnancy test results for female patients of 
childbearing potential or breast feeding. 
14. Enrollment in a concurrent clinical study that in the judgement of 
the investigator would impact study outcomes. 
15. Acute or chronic medical condition that in the judgment of the 
investigator would increase risk to the patient or deem the patient 
inappropriate to participate in the study. 
16. Life expectancy < 12 months based on medical history or the 
medical judgement of the investigator. 
Within 1 month of enrollment or just prior to procedure: 
17. Documented LA thrombus upon imaging. 
18. Creatinine >2.5mg/dl or creatinine clearance <30mL/min.     
Within 3 months of enrollment: 
19. Regularly prescribed amiodarone. 

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20. Significant gastrointestinal (GI) bleed. 
21. Myocardial infarction (MI), unstable angina, cardiac surgery or 
coronary intervention. 
Within 6 months of enrollment: 
22. Coronary artery bypass graft (CABG) procedure.   
23. ICD, CRT leads or pacemaker implant procedure. 
24. Documented stroke, CVA, TIA or suspected neurological event. 
Within 12 months of enrollment: 
25. An episode of AF lasting >7 days in duration.  
Follow-up Visit 
Schedule 
Subject Visit Description 
Timeframe / Visit Window 
Enrollment and Screening 
Vi i ( )
Within 60 days of ablation procedure 
Ablation Procedure (Index) 
Day 0; follow-up visit windows 
determined by ablation procedure 
completion date 
Pre-Discharge  
Prior to discharge from hospital 
following ablation procedure 
7 days Follow-Up (Phone) 
7 ± 3 days 
1 Month Follow-Up  
(Phone or Clinic) 
30 ± 14 days 
3 Month Follow-Up 
90 ± 21 days 
6 Month Follow-Up 
180 ± 28 days 
12 Month Follow-up 
365 ± 45 days 
Unscheduled Visits 
As needed/necessary 
Repeat Ablation Procedure 
Within 90 days of ablation procedure 
(follow-up visit schedule does not 
restart) 
 
 
 

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TABLE OF CONTENTS 
1. 
STUDY CONTACT INFORMATION ............................................................... 2 
2. 
REVISION HISTORY ......................................................................................... 5 
3. 
PROTOCOL SUMMARY ................................................................................... 6 
4. 
INTRODUCTION............................................................................................... 15 
4.1. 
ATRIAL FIBRILLATION (AF) AND CLINICAL NEED ..................................... 15 
4.2. 
PRIOR CLINICAL EVIDENCE FOR RF ABLATION TO TREAT PAF ................. 16 
5.  
SUMMARY OF FIRST-IN-HUMAN CLINICAL STUDY (TRAC-AF) ...... 17 
5.1. 
TRAC-AF STUDY DESIGN ......................................................................... 17 
5.2 
INVESTIGATIONAL DEVICE ......................................................................... 17 
5.3.  
TRAC-AF CLINICAL ENDPOINTS .............................................................. 18 
5.4.  
STUDY ELIGIBILITY CRITERIA .................................................................... 18 
5.5 
STUDY RESULTS ........................................................................................ 19 
5.6.  
CONCLUSION FROM CLINICAL STUDY ........................................................ 23 
6. 
TACTICATH CONTROL DEVICE................................................................. 23 
6.1. 
INDICATIONS FOR USE................................................................................ 23 
6.2.  
PRODUCT CLASSIFICATION, CODE, REGULATION....................................... 24 
6.3. 
CONTROL DEVICE DESCRIPTION ................................................................ 24 
6.4.  
TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER .................. 24 
6.5.  
TACTISYS QUARTZ EQUIPMENT ................................................................. 25 
6.6. 
ADDITIONAL REQUIRED EQUIPMENT ......................................................... 25 
7. 
DIAMONDTEMP INVESTIGATIONAL DEVICE ....................................... 25 
7.1.  
PROPOSED INTENDED USE OF THE INVESTIGATIONAL DEVICE ................... 25 
7.2. 
PRODUCT CLASSIFICATION, CODE, REGULATION....................................... 26 
7.3. 
INVESTIGATIONAL DEVICE DESCRIPTION ................................................... 26 
7.4. 
DIAMONDTEMP ABLATION CATHETER ...................................................... 27 
7.5.  
DIAMONDTEMP RF GENERATOR ............................................................... 27 
7.6. 
DIAMONDTEMP IRRIGATION PUMP ............................................................ 28 
7.7  
DIAMONDTEMP TUBING SET...................................................................... 29 
7.8. 
DIAMONDTEMP FOOTSWITCH .................................................................... 29 
7.9.  
DIAMOND TEMP CABLES ........................................................................... 29 
7.10. MAPPING SYSTEM AND EP RECORDING SYSTEM COMPATIBILITY ............. 30 

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8. 
STUDY PROTOCOL AND METHODS .......................................................... 30 
8.1. 
 STUDY OBJECTIVE .................................................................................... 30 
8.2. 
 STUDY DESIGN .......................................................................................... 30 
8.3.  
 PRIMARY SAFETY ENDPOINTS ................................................................... 32 
8.4. 
 PRIMARY EFFECTIVENESS ENDPOINTS ...................................................... 34 
8.5.  
SECONDARY ENDPOINTS ............................................................................ 34 
8.6. 
 SAMPLE SIZE JUSTIFICATION ..................................................................... 35 
8.7. 
 STATISTICAL ANALYSIS ............................................................................ 35 
8.8. 
 SITE TRAINING .......................................................................................... 36 
9. 
SUBJECT SELECTION .................................................................................... 36 
9.1.  
CRITERIA FOR ELIGIBILITY ........................................................................ 36 
9.2. 
 STUDY INCLUSION CRITERIA ..................................................................... 36 
9.3.  
STUDY EXCLUSION CRITERIA .................................................................... 36 
10.  
SUBJECT ACCOUNTABILITY ...................................................................... 38 
10.1.  POINT OF ENROLLMENT ............................................................................. 38 
10.2.  SUBJECT STATUS AND CLASSIFICATION ..................................................... 38 
10.3.  SUBJECT WITHDRAWAL ............................................................................. 39 
11.  
STUDY METHODS............................................................................................ 39 
11.1.  ENROLLMENT AND VISIT SCHEDULE .......................................................... 39 
11.2. SCREENING EVALUATION .............................................................................. 41 
11.3. BASELINE EVALUATION ............................................................................. 41 
11.4.  PRE-ABLATION TESTING AND REQUIREMENTS .......................................... 42 
11.5.  ABLATION PROCEDURE .............................................................................. 42 
11.6  
PRE-DISCHARGE FOLLOW-UP VISIT .......................................................... 47 
11.7  
SEVEN DAY FOLLOW-UP PHONE CALL ...................................................... 48 
11.8 
 ONE MONTH FOLLOW-UP PHONE CALL OR CLINIC VISIT ......................... 48 
11.9      REPEAT ABLATION PROCEDURE (IF APPLICABLE) ...................................... 48 
11.10   THREE MONTH FOLLOW-UP VISIT ............................................................. 49 
11.11   SIX MONTH FOLLOW-UP VISIT................................................................... 49 
11.12   TWELVE MONTH FOLLOW-UP VISIT ........................................................... 49 
11.13   UNSCHEDULED VISITS ................................................................................ 50 
11.14   SUBJECT LOST TO FOLLOW-UP ................................................................... 50 
11.15   EXTENDED FOLLOW-UP PERIOD (IF APPLICABLE) ....................................... 50 
11.16   STUDY COMPLETION .................................................................................. 50 
12.  
STUDY CONDUCT ............................................................................................ 51 
12.1.  STATEMENT OF COMPLIANCE .................................................................... 51 
12.2.  REGULATORY CONSIDERATIONS ................................................................ 51 

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12.3.  INVESTIGATOR RESPONSIBILITIES .............................................................. 51 
12.4.  CONFIDENTIALITY AND DATA PROTECTION ............................................... 52 
12.5.  INSURANCE ................................................................................................ 52 
12.6.  PROTOCOL AMENDMENTS .......................................................................... 52 
12.7.  ADVERSE EVENT REPORTING..................................................................... 52 
12.8.   DEVICE DEFICIENCY REPORTING ............................................................... 54 
12.9.  PROTOCOL DEVIATIONS ............................................................................. 55 
12.10  INVESTIGATIONAL DEVICE ACCOUNTABILITY ........................................... 55 
12.11.  DOCUMENTATION ...................................................................................... 56 
12.12.  RECORD RETENTION .................................................................................. 57 
13.  
POTENTIAL RISKS AND BENEFITS............................................................ 57 
13.1.  ANTICIPATED ADVERSE EVENTS ................................................................ 57 
13.2.  RISK MINIMIZATION .................................................................................. 59 
13.3.  BENEFITS ................................................................................................... 60 
14.  
MONITORING ................................................................................................... 61 
14.1  
STUDY MONITOR ....................................................................................... 61 
14.2.  MONITORING PROCEDURES ........................................................................ 61 
14.3.  ECG CORE LAB ......................................................................................... 62 
14.4  
DATA SAFETY MONITORING BOARD.......................................................... 62 
14.5.  CLINICAL EVENTS COMMITTEE .................................................................. 62 
14.6.  STEERING COMMITTEE ............................................................................... 63 
15.  
SUSPENSION OR TERMINATION ................................................................ 63 
15.1. PREMATURE TERMINATION OF THE STUDY ................................................ 63 
15.2.  TERMINATION OF PARTICIPATION .............................................................. 63 
16.  
PUBLICATION AND REPORTING POLICY ............................................... 64 
17.  
REIMBURSEMENT AND COMPENSATION FOR SUBJECTS ................ 64 
18.  
ABBREVIATIONS AND DEFINITIONS ........................................................ 65 
18.1.  TABLE OF DEFINITIONS .............................................................................. 65 
18.2.  TABLE OF ABBREVIATIONS ........................................................................ 70 
19.  
BIBLIOGRAPHY ............................................................................................... 72 
 

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4. INTRODUCTION 
4.1. Atrial Fibrillation (AF) and Clinical Need 
Atrial fibrillation (AF) is the most common clinically-significant cardiac arrhythmia. It is a 
major public health concern in the United States, affecting an estimated 2.3 million people 
in North America and 4.5 million people in Europe[1]. It has been projected that the 
prevalence of AF will increase 2.5 fold during the next 50 years in the United States [2]. AF 
is associated with increased cardiovascular morbidity and mortality and the prevalence 
increases over time due to the aging population and an increase in age-specific occurrence 
of AF [3-5].  
Symptoms of AF vary with the ventricular rate, underlying functional status, duration of AF, 
presence and degree of structural heart disease, and individual patient perception; however, 
most patients with AF complain of palpitations, angina, dyspnea, fatigue, or dizziness. AF 
also significantly impairs quality of life, with up to two-thirds of patients reporting it is 
disruptive and debilitating to their lives [6-8]. AF is an abnormal heart rhythm that has been 
classified as recurrent when two or more episodes are detected. If these episodes of AF last 
less than seven days and terminate spontaneously, then it is classified as paroxysmal AF 
(PAF).  PAF accounts for approximately 40 to 45 percent of AF cases. [4, 9]  
AF is a sustained arrhythmia characterized by rapid and disorganized atrial activation 
leading to impaired atrial function, which can be diagnosed on an ECG by lack of a P-wave 
and irregular QRS complexes. The disorganized atrial activation appears as “fibrillatory” 
waves activating the atria at a rate generally between 350 and 600 beats/min and the 
syncytial contraction of the atria is replaced by irregular atrial twitches. While AF can occur 
in isolation, it may also be associated with other arrhythmias such as atrial flutter or atrial 
tachycardia. 
The electrophysiological mechanisms responsible for AF may include rapid focal 
tachyarrhythmia in the pulmonary veins (PVs) and/or other atrial regions with fibrillatory 
conduction, multiple reentrant wavelet conduction initiated by premature atrial complexes 
(PACs) and/or atrial tachyarrhythmia, and/or formation of stable or unstable reentrant 
circuits of very short cycle lengths that generate fibrillatory conduction [10, 11].  
Of all electrophysiological mechanisms responsible for AF, of significant interest are the 
PVs which have been identified to play a critical role in triggering and maintaining AF. 
Haissaguerre and colleagues have demonstrated that in most AF patients, the focus is in one 
of the PVs [12].  
The choice of therapy for AF is influenced by patient preference, associated structural heart 
disease, severity of symptoms and whether the AF is classified as recurrent paroxysmal, 
recurrent persistent or permanent. Although AF can be problematic to manage medically 
due to its progressive nature, there are multiple therapies in current use for the treatment of 
AF, and many of these therapies are sub-optimal for most patients. Treatment options 
include medical management, pacing, cardioversion, implantable devices, surgery and 
ablation therapy to eliminate the arrhythmia[4, 13].  
Of all therapeutic strategies for AF one of interest is radiofrequency catheter ablation 
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performed procedure for symptomatic patients in whom medications are either ineffective or 
not tolerated [4, 9, 14]. RFCA restores normal sinus rhythm by delivering RF energy through a 
catheter at targeted focal sites to disrupt abnormal electrical activity. The most common 
catheter ablation approach to treat AF is to electrically isolate the PVs (PVI).  Other 
approaches used include WACA and CFAE ablation. Additional focal or macroreentrant 
atrial sites may be ablated but the approach varies from center to center.   
Despite significant improvements in catheter ablation strategies to treat AF in recent years, 
Neuzil and colleagues report that refractory recurrence of arrhythmia remains a continuing 
concern with recurrence rates of AF after RFCA still remaining relatively high (20-55%) [15] 
and perhaps attributed to lack of transmural lesions during PVI[16]. Technological 
innovations in RFCA include multi-electrode ablation catheters, high resolution ablation 
catheters, force-sensing technologies and navigation technologies. 
4.2. Prior Clinical Evidence for RF Ablation to Treat PAF   
Ablation has become the standard of care in many centers due to the superiority of catheter 
ablation to AADs.  The first two classes of devices to seek and achieve FDA approval for 
ablation of PAF were an irrigated RF catheter (ThermoCool, Biosense Webster) and a 
cryoballoon ablation catheter (ArticFront, Medtronic).  The prospective randomized studies 
for these devices demonstrated the safety and efficacy and the superiority of catheter 
ablation over drug therapy in drug refractory patients.[17, 18] 
 
Subsequent approval studies of new ablation technologies have been either compared with a 
previously-approved device with the same indications for use in a randomized, controlled 
non-inferiority study or, in the case of a second-generation RF ablation catheter, compared 
with predefined performance goals in a single-arm study.   
Recently, two catheters have been developed to measure real-time contact force during 
ablation, a concept where force is one of the primary factors determining lesion size. One 
catheter uses three optical fibers to measure the micro-deformation of a deformable body in 
the catheter tip (TactiCath, St Jude Medical, Incorporated), which correlates with tip force 
[19-21]. The second catheter uses a small spring between the ablation tip electrode and the 
catheter shaft, with a tiny magnetic transmitter in the tip and magnetic sensors to measure 
microdeflection of the spring (ThermoCool SmartTouch, Biosense Webster, Inc.), 
corresponding to tip force[22-24]. 
The TactiCath catheter was evaluated in the FDA investigational study, TOCCASTAR 
clinical trial[25]. In this prospective, randomized clinical trial, 300 patients with PAF were 
randomized to ablation with the TactiCath catheter or to the non-contact force sensing 
ThermoCool ablation catheter. No difference in efficacy was observed, with success rates of 
67.8% and 69.4% in the contact force (CF) and control arms, respectively. When the CF 
arm was stratified into optimal CF and non-optimal CF groups, effectiveness was 75.9% vs 
58.1%, respectively. There was no difference in the rate of complications in the two groups. 
Cardiac tamponade occurred in one subject in each group. 
The ThermoCool SmartTouch catheter was evaluated in a multicenter, prospective, 
randomized clinical trial performed for FDA approval[24]. The outcomes were compared 
with the ThermoCool IDE trial[18], in which 170 subjects were enrolled. The 12-month 

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freedom from AF/AT/AFL in SMART-AF was 72.5% at 1-year follow-up, compared with 
66% efficacy for the ThermoCool non-contact force catheter. The average CF per procedure 
was 18 grams. Four subjects experienced cardiac tamponade. A post hoc analysis revealed 
that when the CF was between investigator-selected working ranges >80% of the time, 
outcomes were 4.25 times more likely to be successful.  
5.  SUMMARY OF FIRST-IN-HUMAN CLINICAL STUDY (TRAC-AF) 
ACT conducted a multi-center First-In-Human clinical study, TRAC-AF, across four European 
centers to establish evidence of clinical safety and effectiveness of the DiamondTemp Ablation 
System to treat patients with drug refractory, recurrent, symptomatic paroxysmal atrial 
fibrillation (PAF).  
TRAC-AF (DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical 
Trial for Atrial Fibrillation, NCT02821351) study was a prospective, multi-center, single-arm 
feasibility study initiated in 2016 and conducted at four European investigational sites.   
Enrollment was performed in two phases.  Phase 1 included enrollment of 38 subjects from 
January through March of 2016 and Phase 2 included enrollment of an additional 34 subjects 
from June through July 2017.  A total of 72 patients were enrolled in the study and 70 subjects 
were treated with the study device and analyzed.  Enrollment is now closed and all subjects in 
both phases have completed 7-day and 30-day follow-up visits.  Subjects in the first phase have 
completed 12-month follow-up visits and are now exited from the study.   
All primary study endpoints have been met through 30 days follow up.  Assessments of primary 
safety events resulted in four (4) SAEs (5.7%) through the 7-day safety endpoint and five (5) 
SAEs (7.1%) through the 30-day safety endpoint.  The primary effectiveness endpoint of acute 
procedural success was achieved in 100% of subjects.   
Once all subjects in the second phase have completed the 12-month follow-up a final clinical 
study report will be generated.  The focus of this report is on subject follow up through 30-days.   
5.1. TRAC-AF Study Design 
Subjects with symptomatic PAF who were refractory or intolerant to at least 1 anti-
arrhythmic drug (AAD; class I-IV) were screened for enrollment. Subjects that met the 
study eligibility criteria and signed the informed consent form (ICF) were enrolled and 
treated in accordance with the protocol and the HRS/EHRA/ECAS Expert Consensus 
Statement on Catheter and Surgical Ablation of Atrial Fibrillation [14, 26].  Subjects received 
ablation using the investigational device which required electrical isolation of all clinical 
relevant pulmonary veins.  
5.2  Investigational Device 
The investigational device in this clinical study is the DiamondTemp Ablation System.  The 
investigational device was used with a commonly available EP recording system, cardiac 
stimulator and mapping device, the EnSite™ Velocity™ or Precision™ Cardiac Mapping 
System (St. Jude Medical).  There were no control devices in this study. 
 

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5.3.  TRAC-AF Clinical Endpoints 
The primary endpoint events for this trial used to assess the safety and effectiveness of the 
DiamondTemp Ablation System for the treatment of drug refractory, recurrent, symptomatic 
PAF are as follows: 
Primary Safety Endpoint  
The safety of the DiamondTemp Ablation System was assessed by evaluating the nature and 
frequency of serious adverse events (SAEs) and serious adverse device effects (SADEs) 
during the time of the ablation procedure and within 7 days afterwards. 
Long Term Primary Safety 
The long-term safety of the DiamondTemp System was assessed by evaluating the nature 
and frequency of serious adverse events (SAE) and SADEs at 30 days post-procedure. 
Primary Effectiveness Endpoint 
The effectiveness of the DiamondTemp System was evaluated post-ablation by 
demonstration of acute procedural success, defined as isolation of clinically relevant 
pulmonary veins by demonstration of block or isolation of signals confirmed after delivery 
of the ablation treatment.  
Secondary Endpoints 
The chronic safety of the DiamondTemp System was assessed by evaluating the nature and 
frequency of adverse events (AE) and adverse device effects (ADE) at 90 days, 6 months 
and 12 months post-procedure.  
5.4.  Study Eligibility Criteria 
Subjects presenting with drug refractory, paroxysmal atrial fibrillation requiring treatment 
and clinically indicated for standard of care pulmonary vein isolation ablation treatment 
were eligible for screening and potential enrollment in the study.  Enrollment was confirmed 
once the subject signed informed consent, had echocardiographic assessment to confirm 
final eligibility and the study device was introduced into the subject’s vasculature. 
Subjects had to meet all of the defined inclusion and none of the defined exclusion criteria 
to be eligible for enrollment in this study. 
Inclusion Criteria 
1. Suitable candidate for intra-cardiac mapping and ablation for arrhythmias 
2. History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days 
(12) months prior to enrollment 
3. At least 1 episode of AF documented by Holter monitor, rhythm strip, trans-telephonic 
monitor (TTM), or 12-lead ECG prior to enrollment 
4. Refractory to at least one Class I-IV anti-arrhythmic drug (AAD) 
5. Eighteen (18) years of age or above 
 
 
 

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Exclusion Criteria 
1. Previous left atrial ablation procedure  
2. Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction 
and placement 
3. Known severe cerebrovascular disease or history of cerebrovascular event (within 1 
month) 
4. Patients with severely impaired kidney function as measured by a Cockcroft-Gault 
Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. Active gastrointestinal bleeding 
5. Active infection or fever (>100.5 F/38 ◦C)  
6. Sepsis 
7. Cardiac surgery within the past two months. 
8. Short life expectancy (<1 yr.) due to other illnesses, such as cancer or pulmonary, 
hepatic, or renal disease Significant anemia (hemoglobin < 8.0 mg/dL) 
9. Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg within the 
last 30 days) 
10. Documented anaphylaxis during previous exposure to angiographic contrast media 
11. Uncontrolled congestive heart failure (NYHA1 Class III or IV) 
12. Unstable angina or acute myocardial infarction within the past three months 
13. Bleeding, clotting disorders, or known thrombosis 
14. Severe Peripheral vascular disease 
15. Uncontrolled diabetes 
16. Heart valve replacement 
17. Mitral clip (E-valve)  
18. Women who are of childbearing potential who are currently pregnant or not willing to 
use contraception for the duration of the study 
19. Active participation in another investigational protocol currently or the last 30 days 
20. Unable or unwilling to take anti-coagulants 
21. Unwilling or unable to comply with any protocol or follow up requirements 
5.5 Study Results 
Study Accountability and Disposition 
Study enrollment is closed and all subjects in both phases have completed 7-day and 30-day 
follow-up.  Additionally, subjects in the first phase have completed their 12-month follow-
up visits and are now exited from the study. Subjects were followed for 7 and 30 days after 
the index ablation procedure to assess primary safety and effectiveness endpoints. The last 
subject’s 30-day visit was completed on 17 August 2017. Table 1 provides a summary of 
the subject disposition for the study. Although a total of seventy-two (72) subjects met the 
definition for enrollment, analysis of the study results was conducted on seventy (70 
subjects).  
 
 

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Table 1. Subject Accountability and Disposition 
Subject Accountability 
Number 
Subjects enrolled in study 
72 
Subjects who did not have PVI attempted with study device 
(excluded from the analysis) 
2 
Analyzable Population 
70 
Baseline subject demographics for the analyzable subjects are described in Table 2. The 
mean age for subjects in this cohort was 60.5 ± 9.8 years, with a higher incidence of subjects 
being of males (N=42) vs. females (N=28).  Overall the characteristics of the subjects 
enrolled in the study were representative of the patient population usually undergoing RF 
ablation for the treatment of paroxysmal atrial fibrillation. 
Study Population Demographics   
Table 2.  Subject Demographics (n=70) 
Characteristic   
Measurement 
Results 
Age at Ablation Procedure (years) 
Mean ± SD 
60.5 
± 
9.8 
Range 
35 
- 
76 
Gender [N] (%) 
Female 
28 
 
(40%) 
Male 
42 
 
(60%) 
Height (cm) 
Mean ± SD 
173.8 
± 
11.7 
Range 
115.0 
- 
194.0 
Weight (kg) 
Mean ± SD 
91.3 
± 
17.5 
Range 
59.0 
- 
140.0 
Resting Heart Rate (bpm) 
Mean ± SD 
72.2 
± 
17.6 
Range 
47.0 
- 
135.0 
Resting Systolic BP (mmHg) 
Mean ± SD 
142.5 
± 
17.6 
Range 
110.0 
- 
135.0 
Resting Diastolic BP (mmHg) 
Mean ± SD 
82.6 
± 
10.1 
Range 
60.0 
- 
110.0 
Hemoglobin (g/l) 
Mean ± SD 
140.0 
± 
33.5 
Range 
13.1 
- 
176.0 
Creatinine (umol/l) 
Mean ± SD 
88.5 
± 
17.8 
Range 
54.0 
- 
140.1 
GFR (ml/min/1.73m2) 
Mean ± SD 
77.1 
± 
19.0 
Range 
34.0 
- 
128.0 
LVEF %i 
Mean ± SD 
61.2% 
± 
7.2% 
Range 
25.0% 
- 
72.0% 
LA diameter, cmii 
Mean ± SD 
6.6 
± 
9.5 
Range 
2.9 
- 
46.0 
i LVEF not recorded on four subjects 
ii LA diameter not recorded on 14 subjects 

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The medical history of each subject was assessed including history of atrial fibrillation, 
cardiovascular disease, non-cardiovascular disease and cardiac surgery at time of the 
screening visit. Table 3 lists the pre-existing conditions recorded during the screening visits. 
 
Table 3.  Medical History, (N=70) 
PAF History 
N (%) 
History of Prior Ablation Treatment 
0 (0) 
Refractory to Anti-Arrhythmic Drugs  
70 (100) 
Duration of AF (Mean±SD, years)1 
2.6 ± 2.4 
 
Medical History 
 
History of Smoking 
21 (30) 
Diabetes Mellitus Type II 
8 (11.4) 
Previous Stroke or TIA 
6 (8.6) 
Previous Myocardial Infarction  
3 (4.3) 
Coronary Artery Bypass Grafting (CABG) 
0 (0) 
Concurrent Medical Conditions 
 
Hepatic Disease 
9 (12.9) 
Pulmonary disease 
17 (24.3) 
Other Relevant Cardiac Diseases 
 
Hypertension 
38 (54.3) 
Hypertrophic Cardiomyopathy 
0 (0) 
Coronary Artery Disease 
0 (0) 
1Onset date of PAF not collected in first phase subjects; data only 
available on 30 subjects. 
Study Procedural Results  
Pulmonary vein isolation (PVI) was achieved by point-by-point, wide antral ablation encircling 
each pair of ipsilateral PV’s supported by the EnSite Velocity or Precision to collect electrical 
map of the atrium and assist the navigation of the DiamondTemp to each ablation site. The 
investigational device was used with the market-approved EnSite Velocity/Precision in 70/70 
(100%) of the subjects. A summary of procedural data is listed in Table 4. 
 
 
 

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Table 4.  Summary of Procedural Data, (N=70) 
Procedure Data (n=70) 
Measurement 
Results 
Mode of Operation 
Temperature Control 
Programmed Infusion Rate (ml/min) 
Standby Flow Rate – 2 ml/min 
Therapeutic Flow Rate – 8 ml/min 
No. of RF Applications¥ 
                       4662  
Ablation Duration† (sec) 
Mean ± SD 
17.5 ± 2.4 
Range 
10.2 - 
22.4 
Average Power† (W) 
Mean ± SD 
36.2 ± 2.7 
Range 
31.7 - 
41.9 
Max Power* (W) 
Mean ± SD 
50.8 ± 0.4 
Range 
50.2 - 
53.1 
Temperature Set-Point† (°C) 
Mean ± SD 
58.1 ± 1.7 
Range 
51.5 - 
60 
Max Temperature† (°C) 
Mean ± SD 
65.0 ± 3.5 
Range 
56.8 - 
73.8 
Average Temperature† (°C) 
Mean ± SD 
48.2 ± 1.8 
Range 
43.3 - 
52.5 
Max Impedance† (Ω) 
Mean ± SD 
134.7 ± 31.2 
Range 
94 - 
239 
Average Impedance† (Ω) 
Mean ± SD 
96.1 ± 11.3 
Range 
74.9 - 
118.9 
Total RF Ablation Time† (min) 
Mean ± SD 
19.8 ± 8.6 
Range 
8.5 - 
41.8 
Total Procedure Time (mean)   
Mean ± SD 
2:42 ± 1:23 
Range 
1:25 - 
12:15 
Total Fluoroscopy Time‡ (mins) 
Mean ± SD 
9:38 ± 6:38 
Range 
0:03 - 
18:00 
Total fluid vol.§ (ablation procedure) 
Mean ± SD 
322.6 ± 99 
Range 
152 - 
531 
¥RF application count includes all ablations (PVI + atrial tachycardia, etc.) 
† These values were generated from the generator, not the database.   
‡ Fluoroscopic time not recorded on two subjects. 
§ Fluid volume not collected on one subject. 
Once electrical isolation was achieved, ablation in the targeted veins was considered 
complete. Documentation of entrance block into the PVs (PVI) was required for each vein 
ablated. PVI was confirmed by either testing with an adenosine bolus (n=36 or 51% of 
subjects) or confirming PVI after a minimum of 20 minutes (n=34 or 49% of subjects) after 
the last RF application. 
Primary Endpoint Results 
All primary study endpoints have been met through 30 days.  Assessments of primary 
safety events resulted in a total of four (4) SAEs (5.7%) through the 7-day safety endpoint 
and five (5) SAEs (7.1%) through the 30-day safety endpoint, as adjudicated by an 
independent CEC (Table 5).   The primary effectiveness endpoint of acute procedural 
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 Table 5.  Summary of Primary Safety Endpoint (Analyzable Population) 
Event 
DiamondTemp 
N=70 
Timing 
Subjects (%) 
Pericardial Effusion 
1 (1.4%) 
Prior to 7 days 
Transient Ischemic Attack* 
1 (1.4%) 
Prior to 7 days 
Hospitalization for AF recurrence 
1 (1.4%) 
Prior to 7 days 
Hospitalization for chest pain 
1 (1.4%) 
Prior to 7 days 
Supraventricular Tachycardia 
1 (1.4%) 
Prior to 30 days 
Total SAEs through 7 days 
4 (5.7%) 
Total SAEs through 30 days 
5 (7.1%) 
* Pending final adjudication 
Long Term Interim Safety Analysis 
The chronic safety of the DiamondTemp System is assessed in TRAC-AF by evaluating 
the nature and frequency of all serious adverse events at 90 days, 6 months and 12 months 
post procedure, as adjudicated by the CEC.     
To date this additional safety information is only available for the first phase of subjects 
were treated from January through March of 2016 and that have completed and exited the 
study.  The second phase of subjects have reached 30-day follow-up and have been 
analyzed together with the first cohort through the 30-day follow-up as outlined in this 
report.  All subjects will be analyzed together at each additional follow-up interval (90 
days, 6 months and 12 months) and will be reported in the final study report.   
 5.6.  Conclusion from Clinical Study   
The objective of this First-In-Human study was to substantiate the safety and effectiveness 
of the DiamondTemp Ablation System use to ablate cardiac tissue in patients with 
paroxysmal atrial fibrillation. The study endpoints achieved the efficacy performance goal 
demonstrating 100% effectiveness by confirming PVI isolation in all subjects treated as 
intended under this study protocol.  The safety profile demonstrated in this study indicates 
the DiamondTemp System can be used safely in cardiac ablation procedures in this patient 
population, with no incidences of acute serious adverse device-related events (SADEs) and 
a 5.7% to 7.1% safety endpoint rate through 7 and 30 days, respectively.   
The safety results observed in these seventy (70) subjects treated with the DiamondTemp 
System up to 30 days are well within the recommendations of the published literature and 
documented safety and efficacy rates of catheter ablation for PAF[27].   
6. TACTICATH CONTROL DEVICE 
6.1. Indications for Use 
The TactiCath Quartz Contact Force Ablation Catheter is indicated for use in cardiac 
electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic 

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paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency 
generator and three-dimensional mapping system.  
TactiSys Quartz Equipment and accessories are indicated for use in conjunction with a 
TactiCath Quartz Contact Force Ablation Catheter. TactiSys Quartz Equipment allows the 
visualization of the force information coming from the catheter tip. 
6.2.  Product Classification, Code, Regulation 
Device Name: 
TactiCath Quartz Contact Force Ablation Catheter  
Classification: 
Catheter, Percutaneous, Cardiac Ablation, for Treatment of Atrial 
Fibrillation 
Product Code: 
OAE 
Device Class: 
3 
Submission Type: PMA (P130026, Approved) 
6.3. Control Device Description 
The TactiCath Quartz Contact Force Ablation System is comprised of the following 
components:  
• TactiCath Quartz Contact Force Ablation Catheter 
• TactiSys Quartz CF Equipment hardware inclusive of: 
o TactiSys Quartz Unit 
o TactiSoft Software 
o TactiSys Quartz RF Cable 
o TactiSys Quartz Ethernet Cable 
o Equipotential Cable 
o Mains Cord and Adapter 
• Optional Accessories: 
o TactiSys Quartz Mount 
o TactiSys Analog Output Cable 
o TactiSys Quartz Integration Module 
6.4.  TactiCath Quartz Contact Force Ablation Catheter 
TactiCath Quartz Contact Force Ablation Catheter (TactiCath) is a sterile, 7F steerable, 
open-irrigated, multi-electrode RF ablation catheter with a deflectable tip incorporating a 
force sensor and a thermocouple temperature sensor. The catheter is designed to facilitate 
electrophysiology mapping of the heart chambers and to transmit RF current to the catheter 
tip electrode for intracardial ablation. The deflectable distal section of the catheter shaft 
includes four platinum-iridium electrodes (three ring electrodes and one tip electrode) and is 
available in 65 mm or 75 mm length, with a total usable length of 115 cm. At the proximal 

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end of the catheter, a saline port is used to deliver isotonic saline solution to irrigate and 
cool the tip electrode and ablation site, through a 0.7 mm diameter catheter lumen and six 
small holes on the distal electrode tip. The catheter features a tri-axial optical force sensor 
embedded in the tip section which transmits contact force information to the TactiSys 
Quartz Equipment.  
6.5.  TactiSys Quartz Equipment 
The contact force visualization equipment associated with TactiCath is comprised of the 
TactiSys Quartz (TactiSys) unit (hardware and associated cables) and TactiSoft (stand-alone 
software). The TactiSys unit is a non-sterile active signal and data processing unit that 
interconnects the TactiCath catheter to an external RF generator and collects data from the 
catheter to compute contact force and related information transmitted from the catheter. The 
optical measurement system, which is compatible with the force sensing technology 
incorporated in the TactiCath catheter, is comprised of three optical sensor analyzer 
modules. The TactiSoft software displays the contact force information transmitted from the 
catheter through an Ethernet connection on a dedicated, properly configured computer.  
6.6. Additional Required Equipment 
The following devices are required in addition to the TactiCath Quartz System to perform 
catheter ablation procedures:  
• AMPERE Generator (St. Jude Medical) or Stockert Generator (Biosense Webster) 
• Cool Point Irrigation Pump (St. Jude Medical) or CoolFlow Irrigation Pump 
(Biosense Webster) 
• Electrophysiology recording system and cardiac stimulators 
• Dedicated Personal Computer with display screen to run TactiSoft software  
• St. Jude EnSite Velocity or Precision Cardiac Mapping System 
Optional accessories include choice of RF cable, Ethernet cables available in different 
lengths, an analog output cable, a mount and an integration module (Ethernet - switch) that 
will allow the integration of contact force information with third party equipment (e.g. 
integration in the screen of 3D mapping system for enhanced electrophysiology laboratory 
set-up).  
7. DIAMONDTEMP INVESTIGATIONAL DEVICE 
7.1.  Proposed Intended Use of the Investigational Device 
The DiamondTemp Catheter is indicated for use in cardiac electrophysiological mapping 
(stimulation and recording) and for treatment of drug refractory, recurrent, symptomatic 
paroxysmal atrial fibrillation when used in conjunction with the DiamondTemp Generator and 
accessories (DiamondTemp Cable-to-RFG Cable, DiamondTemp GenConnect Cable, 
DiamondTemp Irrigation Pump/Tubing Set) and compatible mapping system. 

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7.2. Product Classification, Code, Regulation 
Device Name: 
DiamondTemp Ablation Catheter 
Classification: 
Catheter, Percutaneous, Cardiac Ablation, for Treatment of Atrial 
Fibrillation 
Product Code: 
OAE 
Device Class: 
3 
Submission Type: PMA 
7.3. Investigational Device Description 
The ACT DiamondTemp Ablation System investigational device includes: 
• DiamondTemp Catheter  
• DiamondTemp Catheter-to RFG Cable  
• DiamondTemp GenConnect Cable  
• DiamondTemp RF Generator  
• DiamondTemp Irrigation Pump  
• DiamondTemp Irrigation Tubing Set 
• DiamondTemp Footswitch (optional) 
The DiamondTemp Ablation System can be used with the St. Jude EnSite Velocity or 
Precision Cardiac Mapping System and commonly available EP recording systems and 
cardiac stimulators. 
A representative DiamondTemp Ablation System is illustrated in Figure 1. 
 
Figure 1. DiamondTemp Ablation System 
EGM Cable  
(not supplied) 

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Key features of the DiamondTemp System: 
• The DiamondTemp System allows for cardiac mapping, pacing and ablation when 
connected to the St. Jude EnSite Velocity or Precision Mapping System and 
commercially-available cardiac stimulators and recording systems.   
• The DiamondTemp Catheter design, materials and composite tip geometry allow 
for the recording of local electrograms at the ablation site. 
• Six thermocouples at the DiamondTemp Catheter tip provide surface temperature 
feedback. 
• The DiamondTemp Generator modulates power to maintain catheter-tissue 
interface temperature at a set point optimal for creating an effective lesion without 
char or thrombus formation.  
• The DiamondTemp Generator displays the ablation parameters and the composite 
temperature recorded from the thermocouples. 
All investigational devices for use in the clinical study are identified with model, lot or 
serial number and will be tracked for dispositioning throughout the study. For the 
DiamondTemp Ablation Catheter and DiamondTemp Catheter-to-RFG Cable, in addition to 
the model and lot number, a unique serial number will be used. System Accessories used in 
the clinical study will be identified by lot and/or serial number. 
7.4. DiamondTemp Ablation Catheter 
The DiamondTemp Ablation Catheter (DiamondTemp Catheter) is a sterile, single use, 
externally-irrigated cardiac ablation catheter, 110 cm in length, designed to deliver RF 
energy at the catheter tip electrode for mapping and cardiac ablation. The DiamondTemp 
Ablation Catheter (Figure 2) is a 7.5F uni-directional, externally irrigated catheter designed 
to deliver RF energy to composite tip electrode of the catheter for mapping and cardiac 
ablation.  The distal tip and ring electrodes are designed to record electrocardiogram (EGM) 
signals for mapping and deliver stimulus for pacing. RF emission from the composite tip is 
similar to commercially-available, externally-irrigated catheters   
 
Figure 2.  DiamondTemp Ablation Catheter 
7.5.  DiamondTemp RF Generator 
The DiamondTemp RF Generator (Figure 3) is a temperature-controlled RF generator 
and provides power to the DiamondTemp Catheter at approximately 460 kHz.  It has a 
universal AC power supply and provides isolated communication ports to the 

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DiamondTemp Irrigation Pump and serial output to an external monitor which can 
mirror the RF Generator front panel information (Figure 3b) such as temperature, power 
and impedance curves resulting during RF delivery. 
 
 
Figure 3.  DiamondTemp RF Generator (a) and Front Panel Display (b) 
7.6. DiamondTemp Irrigation Pump 
The DiamondTemp Irrigation Pump (Figure 4) is a peristaltic pump designed to 
deliver normal saline (0.9%, with heparin 1 IU/ml) when used in conjunction with the 
DiamondTemp Irrigation Tubing Set. The Irrigation Pump can be controlled to deliver 
the prescribed therapeutic flow rate of 8 ml/min at all power levels up to 50 Watts. The 
DiamondTemp Irrigation Pump can also be controlled using the touch-screen display 
on the front panel of the DiamondTemp RF Generator or Irrigation Pump.  
 
Figure 4.  DiamondTemp Irrigation Pump 

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7.7  DiamondTemp Tubing Set 
The DiamondTemp Tubing Set is a disposable, one-time use, one-piece tubing that 
connects the DiamondTemp Ablation Catheter to the DiamondTemp Irrigation Pump.  
7.8. DiamondTemp Footswitch 
The DiamondTemp Footswitch (Figure 5) is an optional accessory used for On/Off 
control of RF power delivery. Pressing the footswitch turns RF energy ON. Releasing 
the footswitch terminates delivery of RF energy.  
 
Figure 5.  DiamondTemp Footswitch 
7.9.  Diamond Temp Cables 
DiamondTemp Catheter-to-RFG Cable  
The DiamondTemp Catheter-to-RFG Cable (Figure 6) is 2.4 meters in length, 
supplied sterile, and contains no latex. The cable distal end has a 19-pin connector that 
connects to the DiamondTemp Catheter. The cable proximal end, identified by a green 
band, has a 26-pin connector that connects to either the DiamondTemp RF Generator 
or to the DiamondTemp GenConnect Cable when a mapping system is used.  
 
Figure 6.  DiamondTemp Catheter-to-RFG Cable 
 
 

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DiamondTemp GenConnect Cable  
The DiamondTemp GenConnect Cable (Figure 7) is 2 meters in length and has 4 
connectors. The cable connects the DiamondTemp Catheter-to-RFG Cable to a 
commercially-available mapping system (e.g. St. Jude EnSite Velocity or Precision) 
GenConnect Box (Maestro/EPT) and to the DiamondTemp RF Generator. The cable is 
supplied non-sterile and contains no latex.  
 
Figure 7.  DiamondTemp GenConnect Cable 
7.10. Mapping System and EP Recording System Compatibility 
The DiamondTemp System is used with the St. Jude EnSite Velocity and Precision 
Cardiac Mapping Systems and commonly available EP recording systems and cardiac 
stimulators. 
8. STUDY PROTOCOL AND METHODS 
8.1.  Study Objective 
The objective of this study is to demonstrate the safety and effectiveness of the 
DiamondTemp Ablation System for the treatment of drug refractory, recurrent, symptomatic 
paroxysmal atrial fibrillation (PAF).  The study will be considered successful if the 
investigative device is considered non-inferior to the control device for the primary safety 
and effectiveness endpoints. 
8.2.  Study Design 
The DIAMOND-AF study is a prospective, single-blind, 1:1 randomized, controlled trial 
being performed at multiple centers in the United States, Canada and Europe to evaluate the 
safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug 
refractory, recurrent, symptomatic paroxysmal atrial fibrillation compared to the TactiCath 
Quartz Contact Force Ablation Catheter and compatible ablation system. 
This study will enroll up to 350 subjects diagnosed with PAF at up to 30 investigational 
sites in the US, Canada and Europe.  Investigational sites will have a principal investigator 
(PI) that is responsible for the conduct of a research study as well as sub-investigators.  It is 

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anticipated that at least 50% of the randomized subjects will be enrolled at centers within 
the United States. 
After providing consent, subjects will undergo screening and baseline tests. Subjects that 
meet the eligibility criteria will be randomly assigned to either treatment with the 
investigational or control device only after completion of all screening and eligibility 
procedures. A randomization module within the Electronic Data Capture (EDC) system will 
be used to randomize subjects 1:1 to one of two treatment groups using a blocked 
randomization stratified by site.  Since full eligibility for the study may not be confirmable 
until pre-ablation procedure tests are performed, enrolled subjects will only count towards 
the enrollment ceiling if they receive treatment or treatment was attempted (e.g. the assigned 
treatment catheter was introduced into the vasculature).   
The primary focus of the left atrial ablation procedure is to create a series of point-by-point 
RF lesions encircling the left and right PVs to achieve electrical PVI from the rest of the left 
atrium (LA). Investigators may use their preferred approach to obtain PVI, such as antral or 
WACA ablation targeting PVs segmentally or PV pairs ipsilaterally.  PVI must be 
confirmed by entrance block at least 20 minutes following the last ablation around the 
respective PV.   Targeting non-PV foci and complex fractionated electrograms is not 
recommended in this investigation.  If the investigator identifies additional focal or 
macroreentrant atrial sites to be clinically relevant to AF and requiring ablation, the ablation 
location will be documented. 
All subjects will be followed per protocol in relation to the date of the index ablation 
procedure. Follow up will be required prior to hospital discharge and at 7 days, 1 month, 3 
months, 6 months and 12 months post-ablation.   
Subjects will be given a cardiac event monitor (Sentinel Wireless ECG Recorder System or 
equivalent, HeartcoR Solutions, LLC.) at the hospital pre-discharge visit to be used 
throughout the duration of the study. If subject exhibits symptoms (e.g. palpitations, 
dizziness, tiredness, lightheadedness, shortness of breath, chest pain, fatigue, syncope) 
associated with AF recurrence at any time after the ablation procedure, they will be 
instructed to record their heart rhythm using their cardiac event monitor and to contact the 
site investigator.  This data will be transmitted to and read at an ECG core lab.  If a subject 
has an arrhythmia recurrence within the first 90 days after the ablation procedure (blanking 
period), one repeat ablation procedure is allowed per protocol.  Investigators should make 
every attempt to schedule a repeat ablation procedure on or before day 90.  The repeat 
ablation procedure must be performed with the assigned investigational or control catheter.  
Repeat ablation procedures performed with a catheter different than originally assigned will 
be a protocol deviation. 
The duration of the study is projected to span approximately 36 months.  The duration 
accounts for:  
• Approximately 12-15 months to enroll all subjects in the trial; 
• Approximately 12 -15 months subject participation from consent to end of 12-month 
follow-up visit window;  

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• Approximately 3-6 months to analyze, report on study results and close the study. 
8.3.   Primary Safety Endpoints 
The primary safety endpoint is defined as freedom from a composite of serious adverse 
events (SAE) occurring within 7-days post-index ablation procedure or hospital discharge, 
whichever occurs later, as adjudicated by an independent CEC to be related to the procedure 
or device.  
The primary safety device- or procedure-related SAE composite will be the combined rate 
of the following events in Table 6. 
 
 

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Table 6.  Primary SAE, Classification and Definition 
Primary SAE 
Severity Classification / Definition[26] 
Atrioesophageal 
fistula  
Creation of direct communication between the left atrium and esophagus 
as documented by esophageal erosion combined with evidence of a 
fistulous connection to the atrium (e.g. air emboli, an embolic event or 
direct observation at the time of surgical repair). A CT or MRI scan is 
recommended to document event.   
Bleeding 
complication 
Major bleed that requires a transfusion or results in a ≥ 20% fall in 
hematocrit  
Cardiac tamponade / 
perforation 
Significant pericardial effusion with hemodynamic compromise that 
requires elective or urgent pericardiocentesis or results in a 1-cm or 
more pericardial effusion as documented by echocardiography. 
Death 
Cardiovascular related death post ablation 
Myocardial 
infarction  
MI as it relates to AF ablation resulting in the presence of any one of the 
following criteria: 
• ECG changes indicative of new ischemia that persist for > 1 hour 
• development of new pathological Q waves on an ECG 
• imaging evidence of new loss of viable myocardium or new 
regional wall motion abnormality 
Pericarditis 
Pericarditis resulting in an effusion that leads to hemodynamic 
compromise, requires pericardiocentesis, prolongs hospitalization > 48 
hours or persists for more than 30 days following procedure. 
Phrenic nerve 
paralysis 
Absence of phrenic nerve function assessed by a sniff test that persists > 
7 days.  A phrenic nerve paralysis is considered to be permanent when it 
is documented to be present ≥ 12 months following ablation. 
Pulmonary edema 
Pulmonary alveolar fluid accumulation accompanied by typical 
symptoms (dyspnea), physical findings (rales, hypoxemia), radiologic 
findings, and response to diuretic therapy and requiring hospitalization. 
Stroke post-ablation 
Rapid onset of a focal or global neurological deficit with at least one of 
the following: change in level of consciousness, hemiplegia, 
hemiparesis, numbness or sensory loss affecting one side of the body, 
dysphasia or aphasia, hemianopia, amaurosis fugax that persists for >24 
hours as determined by the consulting neurologist and subsequent 
neuroimaging procedure (MRI or CT scan or cerebral angiography). 
Thromboembolism 
Occurrence of deep vein thrombosis or pulmonary embolism post 
ablation 
Transient ischemic 
attack (TIA) post-
ablation 
Rapid onset of new focal neurological deficit with immediate symptom 
resolution (usually 1 to 2 hours), always within 24 hours as determined 
by consulting neurologist and neuroimaging without tissue injury. 
Vagal nerve injury 
Esophageal dysmotility or gastroparesis requiring or prolonging 
hospitalization following an ablation procedure 
Vascular access 
complications  
 
Resulting in development of a hematoma, an AV fistula or a 
pseudoaneurysm that requires intervention, such as surgical repair or 
transfusion, prolongs the hospital stay, or requires hospital admission. 
 

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8.4.  Primary Effectiveness Endpoints 
The primary effectiveness endpoint is defined as freedom from documented symptomatic 
atrial fibrillation (AF) episodes following the blanking period (3-month follow-up post-
ablation procedure) through the end of the effectiveness evaluation period (12-month 
follow-up post-ablation procedure).  
An effectiveness failure is defined by any of the following events during the effectiveness 
evaluation period (3 through 12-month follow-up visits post ablation): 
• Documented episodes of AF lasting ≥ 30 seconds in duration as evidenced by 
electrocardiographic data   
• A repeat ablation procedure to treat AF   
• Use of a new or modification to existing Class I-IV AAD regimen to treat AF 
recurrence   
8.5.  Secondary Endpoints 
Secondary endpoints to characterize the performance of the DiamondTemp Ablation 
System, relative to the control device, will include 
• Freedom from a composite of SAE occurring within 30-days post-index ablation 
procedure as adjudicated by an independent CEC for relatedness to the procedure or 
device.  
• Freedom from documented symptomatic and asymptomatic AT and AFL* episodes 
following the blanking period through 12-month follow-up post-ablation procedure. 
• Freedom from documented asymptomatic AF episodes through the effectiveness 
evaluation period lasting ≥ 30 seconds in duration by ECG or ECG monitoring 
system. 
• Rate of acute procedural success, defined as confirmation of electrical isolation of 
PVs via assessment of entrance block at least 20 minutes following the last ablation 
around the respective PV.    
• Rate of occurrence of electrically reconnected PVs following a 20-minute waiting 
period assessed by entrance block at index procedure.  
• Accumulated changes in QOL using the AFEQT Questionnaire from baseline through 
6 and 12 months following ablation procedure. 
• Neurological changes measured using the NIH stroke scale between baseline and 
post-ablation (pre-discharge visit) and at 12 months post-ablation procedure. 
• Total procedure time (minutes), defined as time of first assigned ablation catheter 
insertion into the vasculature to time of last procedural ablation catheter removed. 
• Time to achieve initial PVI at index procedure (minutes), defined as time of delivery 
of first RF ablation with the assigned ablation catheter until confirmation of PVI via 
exit block following a 20-minute waiting period. 
• Total treatment device time (minutes), defined as time of delivery of first RF ablation 
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• Mean cumulative RF Time (minutes).     
• Mean duration of RF ablations (seconds). 
• Total number of RF ablations per procedure.  
• Total fluid infused through the assigned ablation catheter (mL). 
• Total fluoroscopy time (minutes). 
• Number of re-hospitalizations due to atrial fibrillation recurrence after blanking 
period. 
 
*   Occurrence and/or ablation of cavotricuspid isthmus (CTI)-dependent AFL, as confirmed by 
entrainment maneuvers during EP testing at any time during this study is not a primary 
effectiveness failure because it is not considered an iatrogenic arrhythmia following a left atrial 
ablation procedure for AF. 
8.6.  Sample Size Justification 
With a randomization ratio of 1:1 and an estimated attrition rate of 7-10%, 175 subjects per 
treatment group (total N=350) should yield sufficient power for both the primary safety and 
primary effectiveness endpoints.  For primary safety, assuming a Control composite SAE 
rate of 9%, 159 subjects per group yields 80% power to detect a non-inferiority margin of 
9% between treatment groups at a significance level of 0.025.  Similarly, assuming a 
Control effectiveness rate of 65%, 159 subjects per group yields 80% power to detect a non-
inferiority margin of -15% between treatment groups at a significance level of 0.025. 
8.7.  Statistical Analysis 
Before database lock, the final SAP for clinical data will be prepared to provide full details 
of all planned analyses. The analyses presented here represent an outline of the intended 
methodology. 
Analysis Populations 
Two analysis populations are defined in this study: 
• ITT Population: all randomized subjects regardless of whether they receive study 
treatment, with analyses conducted according to the randomized treatment 
assignment. 
• Safety Analysis Population: all randomized subjects in which treatment was at least 
attempted (assigned treatment catheter inserted into vasculature), with analyses 
conducted by actual treatment received. 
General Considerations 
Descriptive summary statistics for continuous variables will include the number of 
subjects, mean, standard deviation or standard error, median, minimum, and maximum. 
Nominal categorical variables will be summarized using counts and percentages. Ordinal 
variables may be analyzed as if they were continuously scaled. 
 

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Subject Disposition 
The number and percentage of subjects who complete and discontinue as well as reasons 
for early discontinuation will be presented. 
Demographics and Baseline Characteristics 
Demographic and baseline characteristics will be summarized descriptively. Treatment 
groups will be compared statistically to confirm that the randomization process generated 
two homogeneous groups prior to treatment. 
8.8.  Site Training 
Technical training with the DiamondTemp Ablation System will be provided by the 
Sponsor.  Training will be documented and will include a review of the investigational plan, 
study procedures, CRF completion, instructions for use (IFU) and all study compliance 
requirements.   
9. SUBJECT SELECTION 
9.1.  Criteria for Eligibility 
Subjects included in the DIAMOND-AF study should be selected from the general patient 
population indicated for or currently scheduled for catheter ablation of PAF. Investigators 
are responsible for screening all potential subjects and selecting those who meet all 
inclusion and none of the exclusion criteria for the study.  
9.2.  Study Inclusion Criteria 
Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF 
study:  
1. Above eighteen (18) years of age or of legal age to give informed consent specific to 
state and national law.   
2. Patients with a history of symptomatic, paroxysmal atrial fibrillation (PAF) who have 
had ≥ 2 episodes of PAF reported within the 12 months prior to index ablation 
procedure. 
3. At least one episode of PAF ≥ 30 seconds in duration documented by 
electrocardiographic data.  
4. Failure or intolerance of at least one Class I-IV AAD for treatment of PAF.  
5. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia. 
6. Patient agrees to comply with study procedures and be available (geographically 
stable) for follow-up visits for at least 12 months after enrollment. 
7. Patient is willing and able to provide written consent. 
9.3.  Study Exclusion Criteria 
Candidates will be excluded from the DIAMOND-AF study if any of the following 
conditions apply within the following timeframes: 

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At time of enrollment and/or prior to procedure: 
1. 
AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac 
cause. 
2. 
LA diameter > 5.5 cm. 
3. 
LVEF < 35%. 
4. 
Currently NYHA Class III or IV or exhibits uncontrolled heart failure. 
5. 
BMI > 40 kg/m2. 
6. 
LA ablation, septal closure device or mitral valve surgical procedure at any time 
prior to enrollment. 
7. 
Presence of intramural thrombus, tumor or abnormality that precludes vascular 
access, catheter introduction or manipulation. 
8. 
Coagulopathy, bleeding diathesis or suspected procoagulant state 
9. 
Sepsis, active systemic infection or fever (>100.5oF / 38oC) within a week prior to 
the ablation procedure. 
10. Significant restrictive or obstructive pulmonary disease or chronic respiratory 
condition. 
11. Renal failure requiring dialysis or renal compromise that in the investigator’s 
judgement would increase risk to the patient or deem the patient inappropriate to 
participate in the study. 
12. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used 
in conjunction with the study or contrast sensitivity that cannot be adequately pre-
treated prior to the ablation procedure. 
13. Positive pregnancy test results for female patients of childbearing potential or breast 
feeding. 
14. Enrollment in a concurrent clinical study that in the judgement of the investigator 
would impact study outcomes. 
15. Acute or chronic medical condition that in the judgment of the investigator would 
increase risk to the patient or deem the patient inappropriate to participate in the 
study. 
16. Life expectancy < 12 months based on medical history or the medical judgement of 
the investigator. 
Within 1 month of enrollment or just prior to procedure: 
17. Documented LA thrombus upon imaging. 
18. Creatinine >2.5mg/dl or creatinine clearance <30mL/min.     
Within 3 months of enrollment: 
19. Regularly prescribed amiodarone. 
20. Significant GI bleed. 
21. MI, unstable angina, cardiac surgery or coronary intervention. 

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Within 6 months of enrollment: 
22. CABG procedure.   
23. ICD, CRT leads or pacemaker implant procedure. 
24. Documented stroke, CVA, TIA or suspected neurological event. 
Within 12 months of enrollment: 
25. An episode of AF lasting >7 days in duration. 
10.  SUBJECT ACCOUNTABILITY 
10.1.  
Point of Enrollment 
Since full eligibility for the study may not be confirmed without pre-ablation procedure 
testing (e.g. echocardiography, pregnancy test, creatinine), consented subjects will be 
considered enrolled and count towards the maximum enrollment ceiling once they are 
randomized, final eligibility is confirmed and the assigned treatment catheter has been 
introduced into the vasculature (regardless of treatment). 
10.2.  
Subject Status and Classification  
The following classifications will be applied to all subjects: 
• Screening Failure: A subject who has consented (signed ICF) but is found to not meet 
eligibility criteria through medical file review and/or screening procedures to confirm 
eligibility. Screening failures do not count against the maximum study enrollment 
ceiling and there are no follow-up requirements.  If screening failure occurs after 
randomization but prior to insertion of the assigned treatment catheter, the screening 
failure will be documented. 
• Intent-to-Treat: Includes all subjects who sign ICF, meet eligibility criteria, are 
randomized into one of the two study groups and have the assigned treatment catheter 
inserted into the vasculature or any other RF ablation procedure attempted.  These 
subjects will count against the maximum study enrollment ceiling regardless or any 
deviation from the protocol or subsequent withdrawal from study.  All intent-to-treat 
subjects will be followed for a minimum of 30 days post-procedure. Exit from the 
study will be documented.  The primary safety and effectiveness endpoints analysis 
will be used to demonstrate the non-inferiority of the DiamondTemp treatment to the 
control.  
• Treatment-Per-Protocol: A subject who is successfully treated per the study protocol 
with the assigned randomized treatment catheter. These subjects are followed in 
accordance with the follow-up schedule and are included in all analyses of safety and 
effectiveness.   
The statistical analysis for each classification will be documented in the Statistical Analysis 
Plan (SAP). 

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10.3.  
Subject Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) will be accounted for and documented.  If a subject withdraws from the 
clinical study, the reason(s) will be documented.  Reasons for withdrawal may include 
physician discretion, subject choice to withdraw consent, loss to follow-up or death.  While 
study withdrawal is discouraged, subjects may withdraw from the study at any time, with or 
without reason, and without prejudice to further treatment.   
All applicable case report forms up to the point of subject withdrawal must be completed.  
For subjects who are “lost-to-follow-up” the investigator/center should have at least three 
documented attempts to contact the subject prior to withdrawal from the study.    No 
additional data may be collected after a subject has been withdrawn from the study or 
withdraws his/her consent, for whatever reason.  All open adverse events should be closed 
or documented as chronic.  Data collected up to the point of subject withdrawal may be 
used. 
11.  STUDY METHODS 
11.1.  
Enrollment and Visit Schedule 
Enrollment of subjects will occur at the clinical sites only after the appropriate local and 
national study approvals, “Approval to Enroll” documentation from the Sponsor and written 
informed consent from subjects have been obtained. Table 7 summarizes the study follow-
up and testing schedule: 
 
 

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Table 7.  Follow up and Testing Schedule 
Assessments/ 
Activities 
Baseline 
Evaluation 
Ablation 
Procedure 
Blanking Period 
(Ablation procedure – 3 months post 
procedure) 
Effectiveness Evaluation 
Period 
(3 months -12 months post 
procedure) 
Pre-  
Discharge 
7-Day 
Follow-
Up 
(± 3 
days) 
1-
Month 
Follow-
Up 
(± 14 
days) 
Repeat  
Ablation  
Procedure 
3-
Month 
Follow-
Up 
(±21 
days) 
6-
Month 
Follow-
up 
(± 28 
days) 
12-
Month 
Follow-
up (± 
45 
days) 
Eligibility Screening 
X 
 
 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Patient 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
Limited Physical 
Exam (vitals) 
X 
 
X 
 
 
XA 
X 
X 
X 
12-lead ECG 
  
X 
X 
 
  
XA 
X 
X 
X 
TEE or TTE 
XB 
 
 
 
 
 
 
 
 
TEE, TTE or ICE 
 
XC 
 
 
 
XC 
 
 
 
NIH Stroke Scale 
X 
 
X 
 
 
XA 
 
 
X 
Procedural Data 
 
X 
 
 
 
XA 
 
 
 
Event Monitor 
Recording 
 
 
XD 
XD 
XD 
 
X 
X 
X 
24 hr. Holter Monitor 
 
 
 
 
 
 
 
X 
X 
Cardiac Medication 
Changes 
X 
X 
X 
X 
X 
XA 
X 
X 
X 
Protocol Deviations 
X 
X 
X 
X 
X 
XA 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
XA 
X 
X 
X 
AF Quality of Life 
Survey (AFEQT) 
X 
 
 
 
 
XA 
 
X 
X 
A Only required if a repeat ablation procedure performed. 1 repeat ablation procedure is allowed during Blanking Period.  
B TEE only required if subject does not have imaging data to determine LA diameter, LVEF for eligibility within 180d of ablation procedure 
C TTE, TEE or ICE required pre-procedure to rule out LA thrombus if CHA2DS2-VASc score is ≥ 2, if  LA diameter ≥4.6  or if pre-procedure 
anticoagulation requirements are not met 
D Event monitor recording only required if subject is experiencing symptoms during blanking period 
 
 
 
 
 

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11.2. Screening Evaluation 
Investigators and research staff at each site are responsible for conducting screening 
evaluations and obtaining patient medical history to identify patients that meet eligibility 
requirements per the study inclusion and exclusion criteria.  Sites should maintain a subject 
screening log to document patients evaluated for enrollment into the study that did not 
consent.  A reason for ineligibility or not providing consent should be provided.  Patients 
who meet general eligibility for consideration in the study will sign an informed consent and 
undergo a baseline evaluation. 
11.3. Baseline Evaluation 
After eligible subjects have signed an informed consent form and before the scheduled 
interventional procedure, subjects will undergo a baseline evaluation. This evaluation may 
be conducted up to 45 days prior to the interventional procedure or on the same day. The 
evaluation will include but is not limited to the following:  
• Medical History and Physical Exam: 
o Subject Demographics  
o Limited Physical Assessment 
 Height and weight 
 Resting blood pressure 
 Resting heart rate 
o Medical History  
 History and documentation of PAF  
 NYHA score 
 CHA2DS2-VASc score  
 Cardiovascular or other medical history as it pertains to eligibility criteria 
o Medication History 
 Class I-IV AAD history, current doses and/or failure or intolerance 
 Other:  cardiac, diuretic, and anticoagulation medications 
• Baseline Tests 
o Transesophageal or transthoracic echocardiography (TEE or TTE) *  
 to determine LA diameter and % LVEF 
 to rule out LA thrombus pre-ablation procedure** 
o Pregnancy test for women of child bearing potential 
• Baseline Assessments 
o NIH Stroke Scale administration*** 
o AF Quality of Life Survey (AFEQT Questionnaire version 1.0) 
*  
Only required if subject does not have imaging data within 180 days of procedure to determine LA 
diameter, LVEF for eligibility 
**  
Only required pre-procedure if CHA2DS2-VASc score is ≥ 2, if LA diameter ≥4.6 or if pre-procedure 
anticoagulation requirements are not met 
***  NIH Stroke Scale must be administered by staff certified to conduct assessment 

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11.4.  
Pre-Ablation Testing and Requirements 
• Echocardiogram (TEE or TTE or ICE) must be performed prior to ablation in the 
following instances: 
o To confirm LA diameter and LVEF  
 if not available within 180 days of the ablation procedure  
o  To rule out LA thrombus* in subjects if: 
 Not currently and adequately anticoagulated for 3 weeks or longer 
• If subject is on an oral anticoagulant (OAC) they should be taking 
it regularly for 21 days prior to ablation 
• If a subject is on warfarin prior to ablation, they should have a 
therapeutic International Normalized Ratio (INR) > 2 
 CHA2DS2-VASc score is ≥2 
  LA diameter ≥4.6 cm 
*ICE may be considered to rule out LA thrombus in subjects contraindicated for TEE 
If a thrombus is observed on echo, the subject no longer meets eligibility criteria.  The 
subject can be anticoagulated for 30 days until confirmation is received that the clot has 
resolved but if the clot persists, the subject will not meet eligibility for the study. 
• Discontinuation of AADs prior to the procedure is left to the discretion and practice of 
the investigator and investigational site best practices.   
o Regular amiodarone use must be discontinued 3 months prior to the ablation 
procedure and not restarted after the ablation procedure.    
• Performance of the ablation procedure on uninterrupted anti-coagulation therapy (e.g. 
warfarin or OACs) is strongly recommended. 
o For subjects anticoagulated with a OAC prior to AF catheter ablation, it is 
reasonable to hold one to two doses of the OAC prior to AF ablation with re-
initiation post-ablation. 
• Women of child bearing potential will be required to verify entrance criteria prior to 
procedure by providing documentation of a negative pregnancy test conducted within 7 
days prior to enrollment. 
11.5.  
Ablation Procedure 
Pre-procedural Preparation 
Subjects that meet the eligibility and pre-ablation requirements will be prepped for the 
ablation procedure with the ablation system to which they are randomized.    
The procedures will follow standard hospital practice but should, at a minimum, include the 
following: 
1. Prep and sedate subject per institutional standard practice. 

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a. Method of sedation will be recorded (i.e. conscious sedation or general 
anesthesia). 
b. Placement of an esophageal temperature probe is strongly recommended.  
i. Deviation of the esophageal temperature probe is allowed if standard 
practice at the institution. 
c. Place Ensite Velocity or Precision patches on subject per IFU. 
d. Place commercially available Dispersive Indifferent Electrode (DIP) patch.  
2. Gain vascular access per lab protocol via the femoral veins and/or right or left internal 
jugular or subclavian veins by insertion of sheaths.  
3. Any commercially available 8.5F, fixed or steerable, sheath may be used. 
a. A steerable sheath is recommended to be used with the DiamondTemp Ablation 
Catheter. 
4. Aspirate and flush sheaths with heparinized saline to remove air prior to introduction 
into the body and catheter insertion. 
a. Sheaths (fixed or steerable) should be continuously infused with heparinized 
saline at 1-2ml/min throughout the procedure. 
5. Complete a single or double transseptal puncture to access the LA. 
6. A heparin loading dose should be administered just prior to transseptal puncture 
(recommended) or immediately following.  A standard heparin infusion through 
catheter and sheaths should be given to maintain anticoagulation and activated clotting 
times (ACT) ≥300 seconds throughout the ablation procedure. 
a. ACT must be ≥300 seconds prior to first ablation. 
b. ACT levels should be checked every 20-30 minutes during the ablation procedure. 
c. If ACT is <300 seconds during ablation procedure, more heparin should be 
administered.  
7. Insert and place multi-electrode diagnostic catheters under fluoroscopic guidance.  
a. Placement of intracardiac catheters will be per standard lab practice but must 
include a coronary sinus (CS) catheter and a multi-electrode circular catheter for 
PV mapping and verification of PV isolation and entrance block. 
8. Create a 3D anatomical map of the left atrium and location of the PVs with a 
multielectrode catheter using Ensite Velocity or Precision system. 
a. RF applications and location will be added to the map during the procedure. 
9. A pre-ablation EGM/12 lead ECG documenting the subject’s rhythm at the beginning 
of the procedure will be collected. 
10. All peri-procedural AEs must be recorded on the AE CRF and reported to the Sponsor.  
All device issues, malfunction or deficiencies with the investigational or control 
devices must be reported on the Device Deficiency CRF.  The use of a replacement 
(back-up) device should be indicated on the Procedure CRF. 
 

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TactiCath Quartz Contact Force Ablation Catheter Set-up 
The TactiCath Quartz Contact Force Ablation Catheter and TactiSys Quartz Equipment 
hardware should be prepped and deployed following the operator’s manual, IFUs and 
physician training. General recommended ablation parameters taken directly from the 
TactiCath IFU are listed in Table 8.  Please refer to the TactiCath Quartz Catheter IFU for 
more information. 
Table 8.  TactiCath Recommended RF Application Parameters 
 
DiamondTemp Ablation System Set-up 
ACT DiamondTemp Ablation System and Catheter should be prepped and deployed 
following the respective user manuals, IFUs and physician training.  The recommended 
Generator and Irrigation Pump settings are listed in Table 9. 
Table 9.   Recommended DiamondTemp RF Generator and Irrigation 
Pump Settings 
RF Generator Settings 
Operational Mode 
Temperature Control 
Maximum Temperature Set Point 
60oCelcius 
Maximum Power Setting 
50 Watts 
Ablation Duration 
45 seconds 
Irrigation Pump Settings 
High Irrigation Flow Rate (during ablation) 
8 mL/min 
Low Irrigation Flow Rate (minimum continuous 
flow rate) 
2 mL/min 

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When using the DiamondTemp Catheter, the change in the high-resolution EGM can be 
used to guide the termination of the RF delivery. It is recommended that RF delivery be 
stopped five (5) seconds – ten (10) seconds after EGM amplitude attenuation is reached.  
The point of significant EGM attenuation is defined as the time when there are no more 
changes in the EGM amplitude and/or morphology of the low amplitude signal following 
the initial rapid EGM amplitude drop. 
Investigators are recommended to not ablate for greater than 45 seconds without moving the 
tip of the investigational ablation catheter.   
In the event of a generator cutoff (impedance, temperature) or if a steam pop is observed, 
the catheter must be withdrawn and the tip electrode observed for the presence of char or 
coagulum formation. The tip should be cleaned, if necessary, before RF current is reapplied. 
Purge the catheter prior to insertion into the subject. 
Pulmonary Vein Electrical Mapping 
The electrical activity of the PVs must be mapped prior to ablation. The investigator may 
determine the order in which the PVs are mapped and if PV angiography is necessary to 
facilitate vein access.   
To perform the electrical PV mapping, each vein should have a diagnostic catheter inserted 
to document the presence of PV potentials.  Documentation of the PV electrical mapping 
(PV potentials or lack thereof) is required for each vein. If the mapping catheter is 
successfully positioned in the vein but no PV potentials are present, ablation of the PV is not 
recommended.  Pre-ablation mapping determines which veins are clinically relevant for 
appropriate declaration of acute procedural success.  If the investigator determines it is not 
clinically relevant to perform ablation of a PV, the rationale must be noted prior to starting 
the ablation. 
 
Index Ablation Procedure 
The primary focus of the ablation procedure will be to create a series of point-by-point RF 
lesions encircling the left and right PVs to achieve PVI (electrical isolation of PVs from the 
LA).  
Investigators may use their preferred approach to obtain PVI such as antral or WACA 
targeting PVs segmentally or PV pairs ipsilaterally.  A circumferential approach applying 
RF application 1-2 cm outside of the PV ostium to prevent PV stenosis is recommended.  
Targeting non-PV foci and complex fractionated electrograms is not recommended in this 
investigation.  If the investigator identifies additional focal or macroreentrant atrial sites to 
be clinically relevant to AF and requires ablation, the ablation location will be documented. 
The order in which PVs are isolated is up to the investigator’s discretion.  While isolating 
the right superior PV, high-voltage pacing may be used before each RF application to check 
for phrenic nerve stimulation.  Ablation should be avoided in areas of phrenic nerve capture 
as to not cause injury to the phrenic nerve.  While ablating on the posterior wall in proximity 
to the esophagus it is highly recommended that Investigators use an esophageal temperature 
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energy delivery.  Each ablation on the posterior LA wall needs to consider the duration, 
power and temperature (investigational catheter only) settings while in proximity to other 
structures that could potentially be injured, such as the esophagus.  Moving a catheter after 
shorter durations of RF application, reducing the power (W) and/or temperature set point 
(investigational system only) is encouraged but is left to the discretion of the investigator. 
PVI must be confirmed and documented by entrance block of potentials into the PV a 
minimum of 20 minutes following the last RF application in each PV or PV pair to monitor 
for PV reconnection. Adenosine (recommended) and/or isoproterenol may be administered 
20 minutes following PVI to detect for the presence of dormant PV conduction.  
Administration of isoproterenol for the sole purpose to identify non-PV triggers is allowed 
but not recommended.   Exit block testing is not required, but if performed, exit block must 
be demonstrated for the PVI to be considered successful. If conduction resumes in any of 
the PVs, additional RF application can be applied until PVI is achieved.  If additional 
ablation is performed following reconnection of PV, PVI must be reconfirmed at a 
minimum of 20 minutes following last ablation in the respective PV or PV pair. 
Investigators may perform additional RF applications determined to be clinically relevant.  
The location and ablation parameters for ablation of non-PV foci must be documented. 
Empiric targeting of complex fractionated electrogram, rotors, ganglionated plexi or 
performing left atrial mitral isthmus or roof lines are not recommended.  Ablation of the CTI 
is allowed if CTI-dependent (typical) flutter is induced during the procedure or if the subject 
has a known history of typical flutter. Cardioversions do not signify procedural failures and 
are not adverse events. A post-ablation EGM/12 lead ECG documenting the subject’s 
rhythm at the end of the procedure will be collected. 
All procedure logistical data, ablation parameters, procedural outcomes, adverse events, 
fluids administered from both catheter and non-catheter sources (i.e., steerable sheath, etc.) 
and medications administered will be recorded and reported throughout the procedure. 
Prophylactic administration of intravenous diuretics during or after the procedure is allowed 
and will not be considered an adverse event.  All ablation catheters must be removed from 
the subject and inspected for char and coagulum formation if there is a generator cutoff 
(impedance or temperature) as well as each time a steam pop is observed.   
Ablation data collected during the procedure will include but may not be limited to: 
• Catheter lot/serial number(s) used  
• Temperature set point 
• Power set point 
• Total number of RF applications for PVI 
• Total number of RF applications during the procedure 
• Total RF time during the procedure 
• ACT levels and times taken 
• Location of additional ablations performed and number of RF applications per 
location 
• Total fluid infused from the ablation catheter 

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• Presence of char or coagulum formation and incidence(s) of steam pops 
• Procedure and fluoroscopy times  
• EP recording system gain and filter settings for the ablation distal recording channel 
and manufacturer 
If at any time during the ablation procedure the investigator is unable to continue the 
ablation with the investigational or control catheter (other than when ablating an RA flutter 
line), the investigator may consider the case a procedural failure and complete the case with 
a device determined best for the subject.  The point at which failure was determined as well 
as the rationale must be documented. 
After removal from the subject, the investigational or control catheter should be inspected, 
and if any abnormalities such as char or coagulum formation are noted on the catheter, it 
must be documented.  All adverse experiences with the investigational device during the 
ablation procedure must be promptly reported to the Sponsor and documented on the CRF. 
Post-Procedure 
All sheaths will be removed immediately after ablation and hemostasis will be achieved 
either by direct pressure or the use of a commercially-available closure device.  
Investigators may use protamine to reverse the intravenous heparin used during the 
procedure. 
Subjects must be anticoagulated for a minimum of 60 days post index ablation procedure.  It 
is up to the investigator’s discretion which drug is best suited for the subject.  If 
anticoagulation was discontinued prior to and during the ablation procedure, anticoagulation 
should be resumed within 24 hours post-procedure to achieve a therapeutic anticoagulation 
level.  It is recommended that investigators follow the anticoagulation guidelines set forth in 
the 2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of 
Anticoagulation in Patients with Nonvalvular Atrial Fibrillation[26]. 
AADs may also be restarted after the procedure at the discretion of the investigator. 
11.6  Pre-Discharge Follow-Up Visit 
Prior to being discharged from the hospital, subjects will be complete a pre-discharge visit.  
The evaluation will include but is not limited to the following: 
• Limited Physical Exam: 
o Weight, resting heart rate, and blood pressure 
• Assess the subject for any adverse events following ablation procedure 
• Perform a 12-lead ECG  
o Report presence or absence of atrial fibrillation or other supraventricular 
tachycardias 
• NIH Stroke Scale Evaluation follow-up 
• Provide subjects with cardiac event monitor and operating instructions 

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• Record medication changes since ablation procedure 
o Cardiac, AAD, diuretic, or anticoagulation 
Subjects will be discharged from the hospital when stable, per the investigator’s discretion.  
11.7  Seven Day Follow-up Phone Call 
All subjects must be evaluated seven days (7 ± 3 days) post ablation procedure.  The follow-
up will be conducted over the phone and the following evaluation will be completed: 
• Adverse Event Assessment 
o Ask the subject if there have experienced any new adverse events since discharge 
from the hospital and inquire about resolution of any previously reported event(s) 
• Medication changes 
o Ask subject if there have been any changes in their regularly prescribed 
medications (cardiac, AAD, diuretic, or anticoagulation) 
• Review event monitor data for recordings made due to symptomatic episodes of 
arrhythmias since the last follow-up 
11.8  One Month Follow-Up Phone Call or Clinic Visit 
All subjects must be evaluated at one month (30 ± 14 days) after the index ablation 
procedure.   During the follow up, the following will be performed: 
• Assess the subject for any new adverse events and inquire about resolution of any 
previously reported events(s). 
• Record any medication changes 
• Review event monitor data for recordings made due to symptomatic episodes of 
arrhythmias since the last follow-up 
o If there has been an early recurrence of AF, investigator should schedule a visit 
so he/she can evaluate subject to determine if a repeat ablation procedure can 
be scheduled before the end of the 90-day blanking period. 
11.9      Repeat Ablation Procedure (if applicable) 
It is expected that some subjects will have early recurrences of AF within the blanking 
period (90 days following the ablation procedure) 18.  Investigators may perform one repeat 
ablation procedure in subjects with early recurrence during the blanking period.   
The repeat ablation procedure must be performed with the originally assigned 
investigational or control catheter.   Prior to the repeat ablation procedure, subjects must 
meet the pre-ablation requirements described in Section 11.4 and repeat baseline NIH 
Stroke Scale and QOL survey.  Investigators must follow all procedural requirements 
defined in Section 11.5 for the repeat ablation procedure.  During the repeat procedure, the 
presence or absence of PV electrical reconnection will be recorded.  In addition, the location 
of reconnection will be noted. 

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The blanking period and follow-up visit schedule will not restart following the repeat 
ablation procedure.  Subjects that receive a repeat ablation procedure will undergo a repeat 
ablation pre-discharge visit.    
11.10   Three Month Follow-Up Visit 
All subjects must be evaluated three-months (90 ± 21 days) following the index ablation 
procedure. During this follow-up visit, the following will be performed: 
• Perform a limited physical exam (weight, resting heart rate, and blood pressure). 
• Assess the subject for any new adverse events and inquire about resolution of any 
previously reported events(s). 
• Perform a 12-lead ECG  
o Report the absence or presence of atrial fibrillation or other atrial 
tachyarrhythmia. 
• Record any medication changes 
• Review event monitor data for recordings made due to symptomatic episodes of 
arrhythmias since the last follow-up. 
11.11   Six Month Follow-Up Visit 
All subjects must be evaluated six-months (180 ± 28 days) following the index ablation 
procedure. During this follow-up visit, the following will be performed: 
• Perform a limited physical exam (weight, resting heart rate, and blood pressure). 
• Assess the subject for any new adverse events and inquire about resolution of any 
previously reported events(s). 
• Perform a 12-lead ECG  
o Report the absence or presence of atrial fibrillation or other atrial 
tachyarrhythmia. 
• Record any medication changes 
• Review event monitor data for recordings made due to symptomatic episodes of 
arrhythmias since the last follow-up. 
• Subjects will be provided a 24-hour Holter monitor  
o Subjects will be given instructions for set-up and return to the core lab   
• Administer a follow-up AFEQT Questionnaire (QOL) 
11.12   Twelve Month Follow-Up Visit 
All subjects must be evaluated twelve-months (365 ± 45 days) following the index ablation 
procedure. During this follow-up visit, the following will be performed:    
• Perform a limited physical exam (weight, resting heart rate, and blood pressure). 
• Assess the subject for any new adverse events and inquire about resolution of any 
previously reported events(s). 

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• Perform a 12-lead ECG  
o Report the absence or presence of atrial fibrillation or other atrial 
tachyarrhythmia. 
• Record any medication changes 
• Review event monitor data for recordings made due to symptomatic episodes of 
arrhythmias since the last follow-up. 
• Subjects will be provided a 24-hour Holter monitor  
o Subjects will be given instructions for set-up and return to the core lab  
• Administer a follow-up QOL assessment (AFEQT Questionnaire) 
• Administer a follow-up NIH Stroke Scale assessment 
11.13   Unscheduled Visits 
Unscheduled visits may occur at any time during the study for the assessment of for example, 
possible adverse events and/or medication changes. Each unscheduled visit will be 
documented in a CRF. 
11.14   Subject Lost to Follow-Up 
The investigator will attempt to contact a subject at least three times prior to designating 
them as lost-to-follow-up subjects; two of these attempts should include attempting to 
contact subject via registered mail.  The investigator will document the date and type of 
attempted communication, and will complete the Study Completion Form when a subject is 
lost to follow-up.  
11.15   Extended Follow-up Period (if applicable) 
Dependent on the safety and efficacy data collected in this study, it is possible that extended 
surveillance of subjects will be requested by a Regulatory Authority, including the FDA 
resulting in an extended follow-up period of up to three (3) years. If extended follow-up is 
requested, subjects would be re-consented and followed per standard of care for their 
Institution with continued adverse event collection and reporting. The information collected 
during these regular follow-up visits would be reported via the EDC system or equivalent 
and the decision to extend follow-up would be documented in a letter communicated at a 
minimum to the Investigators, IRB/EC and regulatory authorities as necessary. CEC review 
of clinical event information and DSMB oversight, if applicable would continue to occur as 
specified in the CEC/DSMB charter.  
11.16   Study Completion  
It is the intent of the protocol that all subjects will be followed for a minimum of 12 months 
post procedure. Documentation of study completion will be required for all subjects, 
independent of the point at which they complete the study (including screening failure, early 
withdrawal or loss to follow-up as applicable). 

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12.  STUDY CONDUCT 
12.1.  
Statement of Compliance 
This study will be conducted in accordance with the ethical principles stated in the latest 
Declaration of Helsinki, ISO 14155: 2011 and FDA 21 CFR parts 50, 54, 56, 812. The study 
will not begin until appropriate national and local approvals have been obtained, as 
appropriate. Any additional requirements imposed by the IRB/EC or regulatory authority 
will be followed where appropriate. 
12.2.  
Regulatory Considerations 
The clinical investigational plan, subject informed consent and associated documents will be 
reviewed by the relevant Ethics Committee (EC)/Institutional Review Board (IRB) and 
appropriate agencies prior to any subject enrollment. The study will not start without the 
written approval of the IRB/EC and, where needed, the FDA and/or Competent Authority 
(CA) approval, and after the completion of any other local regulation requirements. 
12.3.  
Investigator Responsibilities 
The Principal Investigator of an investigational center is responsible for ensuring that the 
study is conducted in accordance with all Clinical Study Agreements, the clinical 
investigational plan and applicable regulations in FDA 21 CFR part 812, as well as any 
prevailing local and/or country laws and/or regulations, whichever affords the greater 
protection of the subject’s rights, safety and welfare. In addition, Investigators are 
responsible for: 
• Ensuring that an IRB/EC reviews and approves Clinical Investigational Plan 
• Maintaining adequate and accurate records related to: 
o Subject eligibility 
o Patient Informed Consent form 
o Study related subject source data as described in clinical investigational plan 
o Case report forms 
o Device accountability log 
o Staff delegation of authority and training logs 
• Ensuring that conducting the study will not give rise to conflicts of interest 
• Informing the Sponsor in writing of the reason(s) for any withdrawal of any IRB/EC 
approval.  
• Ceasing the enrollment of subjects immediately in the event of the withdrawal of any 
IRB/EC approval.  
• Ensuring that no subjects will be enrolled, without prior, written Approval to Enroll 
from the Sponsor.  
• Agreeing to use their best efforts to satisfactorily complete the planned work and 
comply with accepted GCP. 
• Ensuring that informed consent is obtained appropriately and that the conditions of 
informed consent are complied with. 

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• Ensuring the appropriate completion of all CRFs (paper and/or EDC) with the 
understanding that certain records and reports may be submitted to regulatory agencies 
by the Sponsor to support regulatory submissions.  
• Supporting a monitor/auditor (as applicable) in their activities. 
• Informing the Sponsor of all adverse events and adverse device effects in a timely 
manner and informing the IRB/EC of any serious adverse device effects as applicable. 
12.4.  
Confidentiality and Data Protection 
Health data will be recorded and forwarded to the sponsor of the study, and where needed, 
to participating IRB/EC and the FDA/CA for evaluation as required.  Information obtained 
in this study that can be identified with the subject’s identification will remain confidential.  
Any data that may be published in scientific journals will not reveal the identity of the study 
participants.   
12.5.  
Insurance 
As the Sponsor of this clinical investigation, ACT will provide proof and type of insurance 
coverage for subjects in the study, upon request or where required by local/country 
regulations.  
12.6.  
Protocol Amendments 
Changes to this study that affect the safety or welfare of the subject, scope of the 
investigation or scientific integrity of the data will require an amendment to the 
investigational plan.  Amendments to the investigational plan may be initiated by ACT or at 
the request of an Investigator. A formal amendment cannot be initiated by an Investigator or 
clinical site staff without the approval of ACT.  
Protocol amendments must be submitted and subsequently approved by the site IRB/EC and 
CA and FDA, if applicable.  
ACT may make certain administrative changes to the protocol without prior approval of the 
IRB/EC. ACT will notify all investigative sites of such changes to ensure the study 
continues to be conducted consistently across all sites. 
12.7.  
Adverse Event Reporting 
All AEs observed by the Investigator or staff during a physical or laboratory examination, 
interventional procedure or mentioned by the subject, either spontaneously or upon 
questioning, will be recorded on an AE case report form. All AEs will be documented with 
the date of occurrence, relatedness to device or procedure, severity, action taken, resolution 
and any pertinent additional information.  Additionally, the Investigator is responsible for 
providing appropriate treatment for the event and for adequately following the event until 
resolution.  
All adverse events (AE) will be monitored from the time of signed ICF through the twelve-
month follow-up visit.  Table 10 details AE classification, definitions and reporting 
timelines. 

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Table 10.  Adverse Event Classification, Definitions and Reporting Timelines 
Event 
Classification 
Definition 
Reporting Timeline 
Adverse Event  
(AE) 
Any untoward and unintended medical 
occurrence experienced by a clinical study 
subject. An AE can be any unfavorable and 
unintended sign (including an abnormal 
laboratory finding), symptom or disease 
temporally associated with the use of a 
Sponsor’s investigational system or the control 
system, whether it is related to the product or 
not.  
Study staff must complete an AE 
CRF for each AE that occurs per 
subject throughout the duration of 
the study.  AE CRF will be 
completed in a timely manner. 
 
Adverse 
Device Effect 
(ADE) 
AE related to the use of an investigational 
medical device 
Study staff must complete an AE 
and device deficiency CRF within 
2 business days after the event for 
each subject through the duration 
of the study. 
Serious 
Adverse Event 
(SAE) 
AE that: 
• Led to death, 
• Led to serious deterioration in the health of 
the subject, that either resulted in: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body 
structure or a body function, or 
o in-patient or prolonged hospitalization of 
existing hospitalization, or 
o medical or surgical intervention to 
prevent life-threatening illness or injury 
or permanent impairment to a body 
structure or a body function 
• Led to fetal distress, fetal death, or a 
congenital abnormality or birth defect. 
Study staff must complete an AE 
CRF within 2 business days after 
becoming aware of an SAE for 
each subject through the duration 
of the study.   
Study staff must provide all 
relevant / supporting source 
information (de-identified) in a 
timely manner when 
documentation becomes available. 
SAE or SADE will be reported to 
IRB/EC or FDA/CA per 
local/regional regulations. 
Serious 
Adverse 
Device Effect 
(SADE) 
 
ADE that has resulted in any of the 
consequences characteristic of the above-
mentioned SAE. 
Study staff must complete an AE 
and device deficiency CRF within 
2 business days after becoming 
aware of an SAE for each subject 
through the duration of the study.   
Unanticipated 
Adverse 
Device Effect 
(UADE) 
 
 
Any SAE or any life-threatening problem or 
death caused by, or associated with, a device, 
if that effect, problem, or death was not 
previously identified in nature, severity, or 
degree of incidence in the investigational plan 
or risk analysis plan, or any other unanticipated 
serious problem associated with a device that 
relates to the rights, safety, or welfare of 
subjects.   
Study staff must complete and AE 
and device deficiency CRF within 
1 business day of becoming aware 
of the event and report to IRB/EC 
or FDA/CA per local/regional 
regulations. 

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Adverse events will be recorded, reported and followed for all subjects for the duration of their 
participation in the study regardless of whether they are in the investigational or control cohort. 
The Principal Investigator is responsible for informing the IRB/EC, and regulatory authorities of 
UADE(s) and SAE(s) as required by local/regional regulations. 
Planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
investigational plan, without serious deterioration in health, is not considered a SAE.  
Additionally, underlying diseases/ pre-existing conditions will not be reported as an AE unless 
there has been a substantial increase in the severity or frequency of the problem which has not 
been attributed to natural history during the investigation.  To this extent, hospitalizations due to 
recurrent AF / AFL or prolonged hospitalization following procedure to adjust anticoagulation 
regimen or to administer diuretic medication are not considered AEs for this study. 
Device-Related Adverse Event   
An AE is considered to be device-related (ADE) when, in the opinion of the Investigator, 
the clinical event has an association in time and/or proximity with the use of the 
investigational device such that it is reasonable and likely that the investigational device 
directly caused or contributed to the AE. A device-related adverse event that impacts or 
potentially impacts a primary and/or secondary safety endpoint will be reviewed and 
adjudicated by the independent CEC. ADEs include any AE resulting from insufficient or 
inadequate IFU, deployment, operation, or malfunction of the investigational medical 
device, as well as, from intentional misuse of the device. 
Procedure-Related Adverse Event   
An AE is considered to be procedure-related when, in the opinion of the Investigator, it is 
reasonable to believe that the event is associated with the ablation procedure and is not 
specific to the investigational device used and that other products, surgical techniques, or 
medications required specifically for the procedure are likely to have caused or contributed 
to the event. A procedure-related adverse event that impacts or potentially impacts a primary 
and/or secondary safety endpoint will be reviewed and adjudicated by the independent CEC. 
12.8.   
Device Deficiency Reporting   
A device deficiency is defined as any inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance. Device deficiencies include 
malfunctions, misuse or use errors and inadequate labeling.  
Device deficiencies related to the investigational ablation systems may occur in the absence 
of any associated AE and must be completely documented on a CRF.  
Device deficiencies related to the DiamondTemp Ablation System and associated 
accessories should be reported to the Sponsor within two (2) business days and returned to 
the sponsor for analysis as expeditiously as possible. Instructions for returning the clinical 
device(s) will be provided to investigational sites by the Sponsor. If it is not possible to 
return the device, the investigator should document why the device was not returned and the 
final disposition of the device. Device failures and malfunctions should also be documented 
in the subject’s medical record. If a device deficiency is associated with an AE that specific 
event would be recorded as an AE. 

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Device deficiencies related to the control system will be handled per the hospital standard 
complaint handling procedure.  
Note: Any Device Deficiency that might have led to an SAE if a) suitable action had not 
been taken or b) intervention had not been made or c) if circumstances had been less 
fortunate is considered reportable and should be notified to ACT. 
12.9.  
Protocol Deviations 
The Investigator is not allowed to deviate from the protocol without prior approval by 
Sponsor and prior review and documented approval from the governing IRB/EC.   
Under emergency circumstances, deviations from the clinical investigation plan to protect 
the rights, safety and well-being of human subjects may proceed without prior approval of 
the sponsor and the IRB/EC. 
Reports of any deviation from the clinical investigational plan as per above emergency 
circumstances will be reported to the Sponsor and to the IRB/EC as soon as possible after 
detection, but no later than twenty-four (24) hours from the time of the deviation. 
Deviations must be documented on the appropriate protocol deviation CRF. 
Any report of withdrawal of IRB/EC approval will be submitted to the Sponsor within five 
(5) working days. 
If a Clinical Monitor becomes aware that an Investigator is not complying with the signed 
Investigator’s Agreement, the Investigational Plan, the requirements of ISO 14155 or other 
applicable regulations, or any conditions of approval imposed by the reviewing IRB/EC 
Committee, Sponsor will immediately either secure compliance or discontinue shipments of 
the device to the Investigator and terminate the Investigator’s participation in the 
investigation.  The Investigator will be required to return all investigational components to 
Sponsor, unless this action would jeopardize the rights, safety or welfare of a subject. 
Protocol deviations will be analyzed by Sponsor for the impact to the overall integrity of the 
study.  Input from the statistician and/or the Data Safety Monitoring Board (DSMB) may be 
obtained to determine if the deviation warrants disqualifying the Investigator.   
Disqualification is warranted when an investigator has repeatedly or deliberately violated 
governing regulations or has repeatedly or deliberately submitted false information in any 
report.  Where protocol deviations occur, which do not warrant disqualification from a 
study, Sponsor will implement appropriate corrective and preventive actions, including 
repeat training as deemed necessary. 
12.10  
Investigational Device Accountability 
No device supplies will be shipped to the Investigator until IRB/EC and regulatory authority 
(CA and/or FDA) approval has been achieved in writing and each Investigator has supplied 
Sponsor with copies of the IRB/EC approval document and the approved informed consent 
form to be used. 
The investigational devices are to be used only in this clinical investigation and according to 
this protocol and the IFU.  The devices for use in this study must be stored in a secure area.  
The secure area will have restricted access and the study devices will be kept separate from 

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other medical devices. The study devices will only be handled by trained personnel and will 
not be supplied to any individual not involved in the investigation.  The study devices will 
be inventoried at regular intervals during the study and all unused or expired devices will be 
returned to the Sponsor when study enrollment is closed. 
The Principal Investigator or his/her authorized representative is responsible to keep records 
documenting the receipt, use, return and disposal of the investigational devices.  A form will 
be provided to the site that will log the device model, lot number or serial number and date 
received by the site.  As the devices are used, the site will record the subject study 
identification number and date of procedure for each device.  A space will be provided for 
recording returned product and the reason for the return. 
12.11.  
Documentation 
Source documents may include a subject’s medical record, hospital charts, clinic charts, the 
Investigator’s study files, questionnaires and the results of diagnostic tests such as 
laboratory tests, electrocardiograms, CT angiograms, MR angiograms, echocardiograms and 
such.  The Investigator’s copy of the CRFs serves as part of the Investigator’s record of a 
subject’s study-related data. 
The following information should be included in the subject’s medical record: 
• Name and contact information 
• The study title (DIAMOND-AF Study), study number, and Sponsor name (Advanced 
Cardiac Therapeutics or ACT) 
• Date the subject was informed about the study, that he/she had sufficient opportunity 
to ask questions and he/she was informed regarding alternative treatments  
• The subject was allowed adequate time to consider participation prior to signing the 
consent form 
• A statement that written informed consent was obtained 
• Date of enrollment into the clinical study and the subject ID number 
• Date of procedure, procedural type, and device lot number 
• Visit dates 
• Cardiac medications 
• Occurrence of any adverse events 
• Date subject exited the study, and a notation as to whether the subject completed the 
study or discontinued, with the corresponding reason. 
The Investigator is responsible for ensuring that data are properly recorded in each subject’s 
source data, CRFs and related documents and ensuring timely transfer of data to the CRF. 
The Investigator who signs the Protocol Signature Page should sign the CRFs requiring 
signatures to ensure that the observations and findings are recorded correctly and 
completely. Source data from baseline until 12-month follow-up, respectively, must be 
transferred to the CRF. All CRFs will be reviewed for completeness, accuracy and clarity. 
Queries for missing or unclear data will be made as necessary and must be answered within 
10 business days. 

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12.12.  
Record Retention 
The Investigator will maintain, at the investigative site, in original format, all essential study 
documents and source documents that support the data collected on the study subjects in 
compliance to ICH/GCP guidelines. Documents will be retained for at least two (2) years 
after the last approval of a marking application or until at least two (2) years have elapsed 
after the formal discontinuation of the clinical trial of the device. Documents may be 
retained longer by agreement with the Sponsor or in compliance with other local 
regulations. The Investigator will take measures to ensure that these essential documents are 
not accidentally damaged or destroyed. Sponsor requires to be notified in writing if the 
Investigator intends to leave the hospital so that both parties can be assured a new 
responsible person is appointed in the hospital responsible for maintaining these essential 
documents.  
13.  POTENTIAL RISKS AND BENEFITS 
13.1.  
Anticipated Adverse Events  
There are potential or anticipated risks associated with the use of the DiamondTemp 
Ablation System.  The handling characteristics and principles of operation of the 
DiamondTemp System are like conventional RF ablation systems and it is anticipated that 
the rate of catheter/system related complications in this study will be similar to those 
reported from ablation procedures used with commercially approved ablation systems.  
Specific risks are outlined in the system labeling, but in summary the possible risks for 
catheterization and RF ablation are, but are not limited to the following: 
1. Access site complications, including: 
a. Arteriovenous fistula 
b. Ecchymosis 
c. Hematoma 
d. Hemorrhage or aneurysm 
e. Infection 
f. Pain 
g. Surgical correction involving loss of limb 
h. Thrombosis 
2. Sequelae of fluoroscopic exposure, including: 
a. Possible cancer risk 
b. Risk of birth defect 
c. Harm to fetus 
d. Skin burns 
3. Direct cardiac damage, including: 
a. Cardiac tamponade / perforation resulting in pericardial effusion 

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b. Catheter entrapment within heart or blood vessels, leading to damaged heart wall, 
valves, chordae tendineae or blood vessels, possibly requiring surgical correction 
or involving loss of function 
c. Congestive heart failure 
d. Damage to cardiac conduction system 
e. Pulmonary vein stenosis   
f. Endocarditis 
g. Myocardial infarction 
h. Pericarditis resulting in pericardial effusion 
i. Persistence of an atrial septal defect (resulting from the transseptal puncture) 
j. Stiff left atrial syndrome 
k. Valve damage due to catheter entrapment 
4. Other intrathoracic collateral effects, including: 
a. Atrioesophageal fistula  
b. Damage to trachea, bronchi or pulmonary tissue 
c. Damage to great vessels 
d. Esophageal injury 
e. Phrenic nerve injury  
f. Vagal nerve injury 
5. Embolic phenomena including: 
a. Coronary artery embolism with or without myocardial infarction 
b. Gas embolism from procedural error or equipment malfunction with embolic 
phenomenon 
c. Infarction of other tissues 
d. Obstruction of vasculature leading to limbs causing the need for surgical 
interventions, loss of a limb, or loss of organ function 
e. Pulmonary embolism 
f. Paradoxical embolism through patent foramen ovale 
g. Stroke or TIA 
6. Arrhythmias including: 
a. New arrhythmias occur   
b. Worsening of existing arrhythmia 
c. Creation of a partial or complete conduction block, with or without the 
implantation of a temporary or permanent pacemaker 
7. The general sequelae of catheterization including: 
a. Pulmonary edema 
b. Skin burns 
c. Hypotension 
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e. Pneumothorax 
f. Myocardial infarction 
g. Cardiac arrest 
h. Death 
8. Medication side effects, especially: 
a. Heparin administration: including bleeding, thrombosis, changes in circulating 
blood elements and skin necrosis 
b. Ionic and nonionic radiopaque contrast medium, major complications: life-
threatening reactions including: cardiovascular collapse, severe respiratory 
difficulty, nervous system dysfunction, convulsions, coma and cardio-respiratory 
arrest 
c. Ionic and nonionic radiopaque contrast medium, minor complications: allergic 
reactions including: nausea, vomiting, facial flush, feeling of body warmth, 
dermal manifestations of urticaria with or without pruritus, erythema and 
maculopapular rash, dry mouth, allergic glossitis, sweating, conjunctival 
symptoms, facial, peripheral and angio-neurotic edema 
d. Anesthetic reactions: including respiratory difficulties, sedation induced apnea, 
pneumonia, low blood pressure, cardiac arrest (death) and nausea and/or 
vomiting. 
13.2.  
Risk Minimization 
A comprehensive functional risk analysis was performed to quantify the risks associated 
with the use of the DiamondTemp Ablation System. This functional risk analysis evaluated 
the potential interfaces of the DiamondTemp Ablation System with the subject and/or user 
and listed the potential harms and potential causes.  The associated probability of each cause 
was estimated and risk control measures were considered and implemented to further reduce 
the potential for all risks.  
The completed risk analyses of the DiamondTemp Ablation System identified all known 
potential risks to the subject and user.  All risks were categorized in the negligible or 
marginal categories. Since all identified risks were low or moderate, the design is 
determined to be safe for human use. The risk analysis did not result in findings of any risk 
that would be considered intolerable. The potential risks associated with any ablation 
procedure include standard surgical risks for example: infection, electrical shock, 
perforation, tamponade, skin burns and complications associated with use of ancillary 
devices, drugs, and anesthetic.  The DiamondTemp Ablation System does not create new 
risks nor does it increase procedural risks as compared with other ablation systems for 
electrophysiology procedures. The risks associated with the use of the DiamondTemp 
Ablation System have been identified and evaluated, controls have been put in place to 
adequately mitigate risks, and a system is implemented that monitors the effectiveness of the 
risk controls and provides a process to implement corrective and preventive actions 
The DiamondTemp Ablation System is similar in design to existing commercial ablation 
systems and intends to provide an equivalent functionality to existing irrigated 
electrophysiology ablation catheter/systems on the market.  Additionally, technology 
integrated within the catheter allows to measure interface tissue temperature and the RF 

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generator can be set to automatically adjust the power to achieve a desired interface tissue 
temperature. The DiamondTemp Ablation System does not introduce any new or additional 
safety risks beyond those associated with similar cardiovascular and ablation procedures. 
Further, the system is also capable of assessing the extent of contact between the ablation 
electrode and the cardiac tissue ensuring good energy to transfer to the therapy location. 
This study is intended to evaluate the safety and performance effectiveness of the 
DiamondTemp Ablation System for the treatment of atrial arrhythmias. 
Risks associated with the DIAMOND-AF Study can be minimized through appropriate 
training of Investigators and research staff, compliance to this protocol, adherence to 
inclusion / exclusion criteria and by promptly supplying Advanced Cardiac Therapeutics 
with data and information required by this protocol.   
Additionally, extensive in vitro bench and in vivo animal studies have been successfully 
performed with the DiamondTemp Ablation System. Verification and lot release testing for 
all components of the system will be completed. The associated risks proposed in this study 
are similar to risks posed by other interventional, electrophysiological cardiac procedures.  
Based upon the risk analysis conducted to assess the DiamondTemp Ablation System, ACT 
has determined that the benefits of the device can outweigh the risks if used in the 
appropriate patient population by a physician trained in the use of electrophysiology 
procedures.  As a primary treatment for cardiac arrhythmias, the DiamondTemp Ablation 
System is determined to be safe for human use. 
13.3.  
Benefits 
Participants in this research study may or may not receive benefits from participation in this 
study as compared to standard of care treatment of PAF.   
Based on bench and clinical testing with the DiamondTemp Ablation System it is expected 
that the subjects enrolled in this study will experience similar benefits as those of the 
currently available commercial systems.   
Subjects included in this research study may benefit from closer evaluation of their atrial 
fibrillation via more frequent office follow-ups, cardiac event monitoring and from having 
diagnostic non-invasive and invasive evaluation of their cardiac anatomy in the event of 
previously undiagnosed cardiac abnormalities. There is potential that subjects may have 
their AF eliminated or AF burden reduced resulting in a better quality of life and reduced 
need for medication.   
Additionally, there may be a benefit to the subjects enrolled in this study through improved 
therapy delivery.  The DiamondTemp system was designed to provide investigators with 
additional information to a) monitor real-time tissue interface temperatures b) automatically 
adjust output power to a temperature set point based on the composite temperature c) utilize 
a low irrigation flow rate for all power output up to 50 Watts.   
 
 

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14.  MONITORING 
Monitoring will be performed during the study to assess continued compliance with the protocol 
and applicable regulations. Monitoring will occur in line with the Study Monitoring Plan. 
14.1  Study Monitor 
Study Monitors assigned to the DIAMOND-AF study will be responsible for reviewing the 
device accountability documentation and subject data as collected on CRFs or via an EDC 
system. The monitor will ensure that the clinical protocol has been approved by the IRB/EC 
and will assure ongoing compliance with clinical protocol.   
The Investigator/institution guarantees direct access to original source documents by 
Sponsor personnel, their designees, and appropriate regulatory authorities. 
14.2.  
Monitoring Procedures 
Monitoring visits to the clinical sites will be made periodically to ensure that Investigators 
and their staff understand and accept their defined responsibilities, assess compliance with 
current GCP guidelines, evaluate clinical trial progress, assess the continued acceptability of 
the clinical site facilities, assess compliance with the investigational plan, and verify the 
accuracy of data recorded on CRFs or via an EDC system to source documentation.  
The Sponsor Monitor or its designated representative will be allowed to visit the clinical site 
and have direct access to all study records throughout the duration of the study. The Monitor 
will review all source data and compare them to the data documented in the case report 
forms, in addition to performing a review of the Regulatory Binder and conducting device 
accountability. Subject safety will be ensured by noting that consent was properly 
documented, the investigational plan was followed and that AEs were reported and 
followed-up as appropriate. 
The Investigator and/or institution will provide direct access to source data/documents for 
trial-related monitoring, audits, IRB/EC review and regulatory inspection.   
It is important that the Investigator and relevant study personnel are available during the 
monitoring visits and that sufficient time is devoted to the process. 
Additionally, telephone and/or e-mail contact will be conducted on a regular basis with the 
Investigator and the site staff to ensure that the protocol is being followed and to address 
any issues that may occur during the trial. 
If a deficiency is noted during the trial the Clinical Monitor is required to bring this to the 
attention of ACT Clinical Affairs Management to discuss the situation and (if required) to 
secure compliance.  
The study Monitor will evaluate and summarize the results of each clinical site visit in 
written reports, identifying any repeated data problems with any Investigator and specifying 
recommendations for resolution of noted deficiencies. 
As required by IDE regulations, the conduct and monitoring of the clinical investigation will 
be conducted in accordance with the Sponsor’s approved monitoring plan.    

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14.3.  
ECG Core Lab 
A designated CRO will provide centers and/or subjects with instructions and training on the 
use of an event monitors that serves as a hand-held event recorder for short duration 
recordings and can be worn as a 24 hr. Holter.  Subjects will be provided with an event 
monitor prior to discharge from the hospital and instructed to collect 1-minute ECG 
recordings with their event monitor if they experience AF symptoms.  The event monitors 
will be configured to automatically transmit recordings securely and wirelessly to the core 
lab.  All events will be analyzed by the core lab to determine if symptoms are associated 
with arrhythmia recurrence.  The core lab will be blinded to subject treatment assignment.  
The company will identify the subject’s transmitted rhythm and send reports to the 
investigational center within 72 hours.  If there is discordance between the core labs rhythm 
analysis in the report and the investigator, a third-party cardiologist will be used for final 
rhythm determination.  All event monitors should be returned to the Core Lab after a subject 
completes the study. 
At 6 and 12 months post-ablation procedure, the event monitor will be configured to take a 
24-hr continuous reading (like a Holter monitor) supplied by the core lab.  
14.4  Data Safety Monitoring Board 
The purpose of the DSMB committee is to complete unbiased review of all safety data in 
comparison to the established criteria in order to determine if the rate of SAEs is acceptable, 
to evaluate interim data analysis results, to provide related advice on study management and 
progress, and to make any recommendations regarding the study protocol. Members of the 
DSMB will be comprised of three (3) voting individuals with relevant expertise for the 
study and a biostatistician, they will not be employees or shareholders of ACT and they will 
not be a participating DIAMOND-AF Investigator.      
The DSMB will be responsible to communicate any safety, scientific concerns, or other 
perceived concerns to ACT or designee as soon as possible. The DSMB will provide, after 
each scheduled meeting, written recommendation regarding the continuation of the trial, 
early stopping, or any suggested changes for the conduct of the trial. ACT is responsible for 
informing the IRB/EC and regulatory authorities, as applicable, if the DSMB has advised 
them of any major safety concerns and has recommended the study be stopped or if they 
have made any recommendations to alter the study. DSMB decisions are final and non-
negotiable by the sites. 
14.5.  
Clinical Events Committee 
The purpose of the CEC is to complete unbiased reviews and classification of serious 
adverse events and deaths reported by clinical study investigators. The CEC will consist of 
physicians who are not participating Investigators in the DIAMOND-AF Study and who do 
not have any significant investment in Sponsor’s or any of their entities. The three (3) voting 
DSMB members will also serve on the CEC to provide an independent unbiased review and 
adjudication of clinical events throughout the trial. A complete description of CEC and 
DSMB responsibilities, qualifications, members and operating principles will be outlined in 
a combined charter. 

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14.6.  
Steering Committee 
The DIAMOND-AF Steering Committee is comprised of senior clinical, medical and 
regulatory members of ACT, as well as international physician investigator advisors and the 
study statistician. The role of the Steering Committee is to provide oversight of the clinical 
study regarding the design, submission and conduct of the study. Steering Committee 
members may participate in the review and approval of all requests for data analysis, 
abstract and manuscript preparation, and submission; however, ACT remains responsible for 
all decisions related to any such requests in line with approved study agreements. 
15.  SUSPENSION OR TERMINATION 
15.1. Premature Termination of the Study 
ACT reserves the right to terminate the study at any stage but intends to exercise this right 
only for valid scientific or administrative reasons and reasons related to protection of 
subjects.  Investigators, associated IRBs/ECs, and regulatory authorities, as applicable, will 
be notified in writing in the event of study termination. 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
• The occurrence of UADEs that present a significant or unreasonable risk to subjects 
enrolled in the study; 
• A decision on the part of Advanced Cardiac Therapeutics to suspend or discontinue 
development of the device. 
15.2.  
Termination of Participation  
Any investigator or IRB/ EC involved in the DIAMOND-AF study may discontinue 
participation in the study or withdrawal approval of the study, respectively, with suitable 
written notice to Advanced Cardiac Therapeutics Investigators, associated IRBs/ECs, and 
regulatory authorities, as applicable. 
Requirements for Documentation and Subject Follow-up 
In the event of premature study termination by the Sponsor, a written statement as to why 
the premature termination has occurred will be provided to all participating centers by ACT. 
The IRB/EC and regulatory authorities, as applicable, will be notified. Detailed information 
on how enrolled subjects will be managed thereafter will be provided.  
In the event an IRB or EC terminates participation in the study, participating investigators, 
associated IRBs/ECs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be provided 
by ACT. 
In the event an investigator terminates participation in the study, study responsibility will be 
transferred to a co-investigator when possible or another authorized clinical Investigator.  In 
the event there are no opportunities to transfer investigator responsibility; detailed 
information on how enrolled subjects will be managed thereafter will be provided by ACT. 

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The investigator must return all documents and investigational product to ACT, unless this 
action would jeopardize the rights, safety, or welfare of the subjects. 
Criteria for Suspending/Terminating a Study Center 
ACT reserves the right to stop the inclusion of subjects at a study center at any time if no 
subjects have been enrolled for a period beyond 3 months after the site has been granted 
Approval to Enroll or if the center has multiple or severe protocol violations/noncompliance 
without justification and/or fails to follow remedial actions. 
In the event of termination of investigator participation, all study-related devices and 
equipment, as applicable, will be returned to ACT unless this action would jeopardize the 
rights, safety or well-being of the subjects. The IRB/EC and regulatory authorities, as 
applicable, will be notified. All subjects enrolled in the study at the center will continue to 
be followed per protocol-defined follow-up.  The Principal Investigator at the center must 
make provision for these follow-up visits unless ACT notifies the investigational center 
otherwise. 
16.  PUBLICATION AND REPORTING POLICY 
Advanced Cardiac Therapeutics is committed to the publication and dissemination of clinical 
study results.  Any publication or presentation relating to the DIAMOND-AF Study will require 
that ACT’s role as a sponsor or financial supporter is included.  
The final clinical study report of the conclusions of this study will be written within six (6) 
months of the closing of the database at the end of the study.  The report will be signed by the 
global study principal investigators and provided to all study investigators.  The study protocol 
will be registered at www.clinicaltrials.gov before the inclusion of any study subjects. 
17.  REIMBURSEMENT AND COMPENSATION FOR SUBJECTS  
Travel and other expenses incurred by subjects because of participation in the study may be 
reimbursed in accordance with pertinent country laws and regulations and per the study site’s 
regulations.   
 
 

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18.  ABBREVIATIONS AND DEFINITIONS  
18.1.  Table of Definitions  
Term 
Definition 
ACT 
ACT is a test that is used to monitor the effectiveness of the 
administration of Heparin through measuring activated clotting 
time (ACT) 
Asymptomatic AF, 
AT or AFL 
Also known as silent AF or silent atrial tachycardia (e.g. AT, 
AFL). Defined as an opportune diagnosis of AF, AT, and/or AFL 
with electrocardiographic data; specifically, subject’s event 
monitor, 24 hr. Holter monitor or 12 lead ECG at clinic visit. 
Atrioesophageal 
fistula  
Creation of direct communication between the left atrium and 
esophagus as documented by esophageal erosion combined with 
evidence of a fistulous connection to the atrium (e.g. air emboli, 
an embolic event or direct observation at the time of surgical 
repair). A CT or MRI scan is recommended to document event.   
Attempt Subject 
Refers to a subject who has been enrolled and has treatment 
catheter introduced but does not receive an ablation with the 
treatment or control catheter per protocol. 
Blanking Period 
The ~ 90-day period between ablation procedure and the 3-month 
follow-up visit.  During the blanking period, a repeat ablation can 
be performed with the same treatment catheter subject originally 
randomized to and was treated with.  Subjects can be prescribed 
antiarrhythmic drugs as determined necessary by the investigator 
during blanking period. 
Bleeding 
complication 
Major bleed that requires a transfusion or results in a ≥ 20% fall 
in hematocrit  
Cardiac tamponade / 
perforation 
Significant pericardial effusion with hemodynamic compromise 
that requires elective or urgent pericardiocentesis or results in a 1-
cm or more pericardial effusion as documented by 
echocardiography. 
CHA2DS2-VASc 
score 
Clinical prediction rules for estimating stroke risk in patients with 
non-rheumatic AF.  The rule gives a better risk stratification of 
low-risk patients than CHADS2 score by inclusion of additional 
stroke risk modifier risk factors. 
Condition 
Points 

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C 
Congestive heart failure (or LV systolic 
dysfunction) 
1 
H 
Hypertension (consistently > 140/90mmHg or 
treated) 
1 
A2 
Age ≥ 75 years  
2 
D 
Diabetes Mellitus 
1 
S2 
Prior stroke or TIA or thromboembolism 
2 
V 
Vascular disease (e.g. peripheral artery disease, 
MI, aortic plaque) 
1 
A 
Age 65-74 years 
1 
Sc 
Sex category (i.e. female sex) 
1 
Char 
The remains of solid biomass originating from intracavity blood 
or myocardium that has formed as proteins in the blood are 
denatured by excessive heating that present as friable material 
observed on the catheter after RF ablation.  
Congestive Heart 
Failure 
Heart doesn’t pump properly and fluid builds up in arms, legs, 
ankles, feet, lungs, or an organ. 
Coagulum 
The remains of solid biomass originating from intracavity blood 
or myocardium that has formed as proteins in the blood are 
denatured by excessive heating that present as adherent material 
observed on the catheter after RF ablation.  
Death 
Cardiovascular related death post ablation 
Effectiveness 
Evaluation Period 
The period between subject’s 3-month follow-up visit and 12-
month follow-up visit during which the primary effectiveness 
endpoint will be assessed. 
Enrolled Subject 
All subjects who sign ICF, meet eligibility criteria, are 
randomized into one of the two study groups and have the 
assigned treatment catheter inserted into the vasculature or any 
other RF ablation procedure attempted. 
Heart block 
Damage to the heart’s electrical system that controls heart 
rhythm. 

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Hemoptysis 
Coughing up blood 
Femoral (groin) 
hematoma 
Bleeding at the catheter insertion site that causes swelling or a 
pocket of blood.  May need to be drained or require additional 
procedure. 
Long Standing 
Persistent AF 
Long-standing persistent AF is defined as continuous AF of 
greater than 12 months duration. 
Myocardial 
infarction  
MI as it relates to AF ablation resulting in the presence of any 
one of the following criteria: 
• ECG changes indicative of new ischemia that persist for > 1 
hour 
• development of new pathological Q waves on an ECG 
• imaging evidence of new loss of viable myocardium or new 
regional wall motion abnormality 
Paroxysmal Atrial 
Fibrillation (PAF) 
Recurrent atrial fibrillation that last ≥ 30 seconds and terminates 
spontaneously within 7 days.  
Pericardial effusion 
Accumulation of blood between heart and lining of the heart 
(pericardium).  It is not uncommon to observe “trace” pericardial 
effusion following AF ablation.  Trace effusion that does not 
need intervention is not considered a serious AE. 
Persistent Atrial 
Fibrillation   
Recurrent atrial fibrillation that lasts ≥ 7 days and does not 
terminate spontaneously   
Self-Limiting 
Pericarditis 
Pleuritic chest discomfort with or without pericardial rub and 
ECG changes and did not require additional hospitalization.  
Generally, not an SAE. 
Serious Pericarditis 
Pericarditis resulting in an effusion that leads to hemodynamic 
compromise, requires pericardiocentesis, prolongs hospitalization 
> 48 hours or persists for more than 30 days following procedure. 
Source Data 
Original records (or certified copies) of clinical findings, 
information, observations, or other activities in an investigations 
necessary for the reconstruction and evaluation of the clinical 
study. 
Source Document 
Printed or electronic document containing source data like 
hospital charts / records, lab notes, device accountability records, 
radiographs, signed procedural worksheets, records kept at the 

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investigation site, and at the laboratories involved in the clinical 
study. 
Phrenic nerve 
paralysis 
Absence of phrenic nerve function assessed by a sniff test that 
persists > 7 days.  A phrenic nerve paralysis is considered to be 
permanent when it is documented to be present ≥ 12 months 
following ablation. 
Pulmonary edema 
Pulmonary alveolar fluid accumulation accompanied by typical 
symptoms (dyspnea), physical findings (rales, hypoxemia), 
radiologic findings, and response to diuretic therapy and 
requiring hospitalization. 
Screen Failure 
A subject who has consented (signed ICF) but is found to not 
meet eligibility criteria through medical file review and/or 
screening procedures to confirm eligibility. 
Steam pop 
Excessive tissue temperatures over ~100°C that may result in an 
audible pop.  The pop is a sudden release or explosion due to the 
vaporization of interstitial fluid in myocardium. This may 
produce biotraumas and tissue disruption that is usually clinically 
benign but may cause rupture of thin-walled structures with 
subsequent pericardial tamponade, usually requiring emergency 
periocardiocentesis, and/or surgical repair.  
Stroke post-ablation 
Rapid onset of a focal or global neurological deficit with at least 
one of the following: change in level of consciousness, 
hemiplegia, hemiparesis, numbness or sensory loss affecting one 
side of the body, dysphasia or aphasia, hemianopia, amaurosis 
fugax that persists for >24 hours as determined by the consulting 
neurologist and subsequent neuroimaging procedure (MRI or CT 
scan or cerebral angiography). 
Symptomatic AF, 
AT or AFL 
Symptoms associated with AF, AT or AFL that were experienced 
by the subject, made them seek medical attention, and were 
concurrent with a documented episode by ECG, event monitor 
and/or Holter monitor. Symptoms may have included 
palpitations, irregular pulse (i.e. rapid, racing, pounding, 
fluttering, bradycardic), dizziness, weakness, chest discomfort, 
and breathlessness. 
Thromboembolism 
Occurrence of deep vein thrombosis or pulmonary embolism post 
ablation 
Thrombus 
An aggregation of blood factors, primarily platelets and fibrin 
with entrapment of cellular elements, frequently causing vascular 
obstruction at the point of its formation.  

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Transient ischemic 
attack (TIA) post-
ablation 
Rapid onset of new focal neurological deficit with immediate 
symptom resolution (usually 1 to 2 hours), always within 24 
hours as determined by consulting neurologist and neuroimaging 
without tissue injury. 
Vagal nerve injury 
Esophageal dysmotility or gastroparesis requiring or prolonging 
hospitalization following an ablation procedure 
Vascular access 
complications  
 
Resulting in development of a hematoma, an AV fistula or a 
pseudoaneurysm that requires intervention, such as surgical repair 
or transfusion, prolongs the hospital stay, or requires hospital 
admission. 
Vasospasm 
Sudden narrowing of artery that usually relaxes with medication 
or by waiting a short period of time (minutes). 
Wide Area 
Circumferential 
Ablation (WACA) 
The location of PVI has moved more proximally, from the PV 
ostium to the antral insertion of the PV, several centimeters 
proximal to the PV ostium. This is called “wide area 
circumferential ablation” or WACA, and is also known as PV 
antral isolation.  Technique has several advantages: 1) decreases 
risk of PV stenosis 2) eliminates proximal antral AF triggers 3) 
modification of nerve bundles that innervate the atria and 
contribute to AF maintenance may also be ablated.  
 
 
 

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18.2.  Table of Abbreviations  
Abbreviation 
Definition  
AAD 
Anti-arrhythmic drugs 
ACT 
Activated Clotting Time 
ACT 
Advanced Cardiac Therapeutics 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AF 
Atrial Fibrillation 
AFEQT 
Atrial Fibrillation Quality of Life Survey 
AFL 
Atrial Flutter 
AT 
Atrial Tachycardia 
BMI 
Body Mass Index 
CA 
Competent Authority 
CABG 
Coronary artery bypass graft 
CEC 
Clinical Events Committee 
CF 
Contact Force 
CFAE 
Complex fractionated atrial electrogram 
CS 
Coronary Sinus 
CT 
Computed Tomography 
CTI 
Cavotricuspid Isthmus 
DIP 
Dispersive Indifferent Patch 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee (see IRB for US) 
ECG 
Electrocardiogram 
EDC 
Electronic Data Capture  
EGM 
Electrogram 
EP 
Electrophysiologist 
EU 
European Union 
F 
French size 
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
ICE 
Intracardiac Echocardiography 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
IU 
International Unit 
IV 
Intra-venous 
LA 
Left Atrium 
LVEF 
Left Ventricular Ejection Fraction 
MACE 
Major Adverse Cardiovascular Event  
MRI 
Magnetic Resonance Imaging 
NYHA 
New York Heart Association 
PAF 
Paroxysmal Atrial Fibrillation 

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PI 
Principal Investigator 
PV 
Pulmonary Vein 
PVI 
Pulmonary Vein Isolation 
QOL 
Quality of Life 
RF 
Radiofrequency 
RFCA 
Radiofrequency catheter ablation 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
TEE 
Transesophageal echocardiography 
TIA 
Transient Ischemic Attack 
TTE 
Transthoracic echocardiography 
TTM 
Trans-telephonic Monitor 
UADE 
Unanticipated Adverse Device Effect 
US 
United States 
W 
Watts 
WACA 
Wide area circumferential ablation 
 
 

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19.  BIBLIOGRAPHY 
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the Management of Patients With Atrial Fibrillation): developed in collaboration with 
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25. 
Reddy, V.Y., et al., Randomized, Controlled Trial of the Safety and Effectiveness of a 
Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: 
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