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



DIAMOND-AF II Clinical Investigation Plan 
 
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 Investigator Statement and Signature Page 
Study Product Name 
DiamondTemp Ablation System  
Sponsor 
Medtronic 
Clinical Investigation Plan Identifier 
MDT20012 (TP01071) 
Version Number/Date  
Version H 
 
I have read this Clinical Investigational Plan and agree to adhere to the requirements, and will make a 
reasonable effort to complete the study within the time designated.  I will share this Clinical 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 Clinical 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), ISO14155:2020 (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 subjects 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.  I agree to ensure that the confidential 
information contained in this document will not be used for any purpose other than the evaluation and 
conduct of the Clinical Investigation without the prior written consent of Medtronic. 
 
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. 
 
I agree to disclose if I was involved in an investigation or other research that was terminated, by providing 
an explanation of the circumstances that led to termination to the Sponsor. 
 
 
Investigator’s Signature: 
 
Investigator Role (select one) 
                ☐ Principal Investigator        ☐ Sub-Investigator 
Investigator’s Name: 
 
Institution: 
 
Date: (DD-MMM-YYYY) 
 
 
 

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1. Table of Contents 
1. 
Table of Contents ............................................................................................................... 3 
 
Glossary .............................................................................................................................. 7 
2.1 
Table of Abbreviations .......................................................................................................... 7 
2.2 
Table of Definitions ............................................................................................................... 8 
 
Synopsis ........................................................................................................................... 13 
 
Introduction ..................................................................................................................... 20 
4.1 
Background- Atrial Fibrillation (AF) and Clinical Need ........................................................ 20 
4.1.1 
Prior Clinical Evidence for RF Ablation to Treat Persistent AF .................................... 20 
4.1.2 
Summary Of First-In-Human Clinical Study (TRAC-AF)................................................ 21 
4.1.3 
TRAC-AF Study Design ................................................................................................. 22 
4.1.4 
TRAC-AF Investigational Device .................................................................................. 22 
4.1.5 
TRAC-AF Clinical Endpoints ......................................................................................... 22 
4.1.6 
Study Eligibility Criteria ............................................................................................... 22 
4.1.7 
Study Results ............................................................................................................... 24 
4.1.8 
Conclusion from Clinical Study .................................................................................... 27 
4.2 
Purpose ............................................................................................................................... 27 
 
Endpoints ......................................................................................................................... 27 
5.1 
Primary Safety Endpoint ..................................................................................................... 27 
5.2 
Primary Effectiveness Endpoint .......................................................................................... 29 
5.3 
Secondary Endpoints .......................................................................................................... 30 
5.4 
Ancillary Endpoints ............................................................................................................. 30 
 
Study Design .................................................................................................................... 31 
6.1 
Duration .............................................................................................................................. 31 
6.2 
Rationale ............................................................................................................................. 31 
6.3 
Study Oversight ................................................................................................................... 32 
6.3.1 
Steering Committee .................................................................................................... 32 
 
Product Description.......................................................................................................... 33 
7.1 
General- Product Classification, Code, Regulation ............................................................. 33 
7.2 
Investigational Device Description ...................................................................................... 33 
7.2.1 
DiamondTemp Ablation Catheter ............................................................................... 35 
7.2.2 
DiamondTemp RF Generator ...................................................................................... 36 
7.2.3 
DiamondTemp Irrigation Pump .................................................................................. 36 
7.2.4 
DiamondTemp Tubing Set ........................................................................................... 37 
7.2.5 
DiamondTemp Footswitch .......................................................................................... 37 
7.2.6 
DiamondTemp Cables ................................................................................................. 37 
7.2.7 DiamondTemp EGM Cable (CEDTEGM100) - For US and EU only ...................................... 38 
7.2.8. DiamondTemp Generator Connection Box E (CEDTGCB100) - For US and EU only ........... 38 
7.2.9 Mapping System and EP Recording System Compatibility ................................................. 39 
7.3 
Product Use ......................................................................................................................... 39 
7.4 
Product Training Materials.................................................................................................. 39 
7.5 
Product Storage .................................................................................................................. 39 
7.6 
Product Return .................................................................................................................... 40 
7.7 
Product Accountability ........................................................................................................ 40 
 
Study Site Requirements ................................................................................................. 40 

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8.1 
Investigator/Investigation Site Selection ............................................................................ 40 
8.2 
Investigator Responsibilities ............................................................................................... 41 
8.3 
Study Site Activation ........................................................................................................... 42 
8.4 
Role of Sponsor Representative .......................................................................................... 42 
 
Selection of Subjects ........................................................................................................ 42 
9.1 
Study Population ................................................................................................................. 42 
9.2 
Subject Enrollment .............................................................................................................. 42 
9.3 
Inclusion Criteria ................................................................................................................. 43 
9.4 
Exclusion Criteria ................................................................................................................. 43 
 Study Procedures ............................................................................................................. 44 
10.1 
Schedule of Events .............................................................................................................. 44 
10.2 
Data Collection .................................................................................................................... 45 
10.3 
Scheduled Follow-up Visit Windows ................................................................................... 46 
10.4 
Subject Screening ................................................................................................................ 47 
10.4.1 
Subject Consent .......................................................................................................... 47 
10.5 
Enrollment and Baseline ..................................................................................................... 49 
10.6 
Procedure ............................................................................................................................ 50 
10.6.1 
Pre-Ablation Requirements ......................................................................................... 50 
10.6.2 
Ablation Procedure ..................................................................................................... 50 
10.6.3 
Pre-Discharge Follow-Up Visit ..................................................................................... 54 
10.7 
Scheduled Follow-up Visits ................................................................................................. 55 
10.7.1 
Seven Day Follow-up Phone Call ................................................................................. 55 
10.7.2 
One Month Follow-Up Visit......................................................................................... 55 
10.7.3 
Repeat Ablation Procedure (if applicable) .................................................................. 56 
10.7.4 
Three Month Follow-Up Visit ...................................................................................... 56 
10.7.5 
Six Month Follow-Up Visit ........................................................................................... 57 
10.7.6 
Twelve Month Follow-Up Visit .................................................................................... 57 
10.7.7 
Alternative Methods for Follow-Up Visits ................................................................... 57 
10.7.8 
Unscheduled Visits ...................................................................................................... 58 
10.8 
Protocol Deviations ............................................................................................................. 58 
10.9 
Subject Exit, Withdrawal or Discontinuation ...................................................................... 59 
10.10 Study Completion ................................................................................................................ 59 
10.11 Subject Lost to Follow-Up ................................................................................................... 59 
 Risks and Benefits ............................................................................................................ 60 
11.1 
Potential Risks ..................................................................................................................... 60 
11.2 
Risk Minimization ................................................................................................................ 62 
11.3 
Potential Benefits ................................................................................................................ 63 
11.4 
Risk-Benefit Rationale ......................................................................................................... 63 
 Adverse Events and Device Deficiencies .......................................................................... 63 
12.1 
Adverse Events .................................................................................................................... 63 
12.2 
Device Deficiency ................................................................................................................ 63 
12.3 
Definitions/Classifications ................................................................................................... 64 
12.4 
Reporting of Adverse Events ............................................................................................... 67 
12.4.1 
Adverse Event and Device Deficiency Reporting Requirements................................. 68 
12.5 
Subject Death ...................................................................................................................... 69 

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12.6 
Product Complaint Reporting ............................................................................................. 70 
 Data Review Committees ................................................................................................. 70 
13.1 
Data Safety Monitoring Board ............................................................................................ 70 
13.2 
Clinical Events Committee .................................................................................................. 71 
13.3 
CRO/Core Lab(s) .................................................................................................................. 71 
 Statistical Design and Methods ........................................................................................ 72 
14.1 
Analysis Populations ........................................................................................................... 72 
14.2 
General Aspects of Analysis ................................................................................................ 72 
14.3 
Analysis Execution ............................................................................................................... 73 
14.4 
Primary Objective(s) ............................................................................................................ 73 
14.4.1 
Primary Safety Objective ............................................................................................. 73 
14.4.2 
Primary Effectiveness Objective ................................................................................. 75 
14.5 
Secondary Objective(s) ....................................................................................................... 76 
14.5.1 
Secondary Objective #1 .............................................................................................. 76 
14.5.2 
Secondary Objective #2 .............................................................................................. 76 
14.5.3 
Secondary Objective #3 .............................................................................................. 77 
14.5.4 
Secondary Objective #4 .............................................................................................. 77 
14.5.5 
Secondary Objective #5 .............................................................................................. 77 
14.5.6 
Secondary Objective #6 .............................................................................................. 78 
14.5.7 
Secondary Objective #7 .............................................................................................. 78 
14.5.8 
Secondary Objective #8 .............................................................................................. 78 
14.6 
Ancillary Objective(s) .......................................................................................................... 79 
14.6.1 
Ancillary Objective #1 ................................................................................................. 79 
14.6.2 
Ancillary Objective #2 ................................................................................................. 79 
14.7 
Sample Size Determination ................................................................................................. 80 
14.8 
Minimization of Bias ........................................................................................................... 80 
 Ethics ................................................................................................................................ 80 
15.1 
Statement(s) of Compliance ............................................................................................... 80 
 Study Administration ....................................................................................................... 82 
16.1 
Monitoring .......................................................................................................................... 82 
16.1.1 
Study Monitor ............................................................................................................. 82 
16.1.2 
Monitoring Procedures ............................................................................................... 82 
16.2 
Data Management .............................................................................................................. 83 
16.3 
Direct Access to Source Data/Documents .......................................................................... 84 
16.4 
Confidentiality ..................................................................................................................... 84 
16.5 
Liability/Warranty/Insurance Information.......................................................................... 84 
16.5.1 
Insurance (Canada) ..................................................................................................... 84 
16.5.2 
Insurance (Europe, Middle East, Africa) ...................................................................... 85 
16.6 
Reimbursement and Compensation For Subjects............................................................... 85 
16.7 
CIP Amendments ................................................................................................................. 85 
16.8 
Record Retention ................................................................................................................ 85 
16.8.1 
Investigator Records ................................................................................................... 86 
16.8.2 
Subject Source Documents ......................................................................................... 86 
 Reporting Requirements .................................................................................................. 87 
17.1 
Investigator Reports ............................................................................................................ 87 

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17.2 
Sponsor Reports .................................................................................................................. 90 
 Publication and Use of Information ................................................................................. 93 
18.1 
Publication Committee ....................................................................................................... 93 
 Suspension or Early Termination ..................................................................................... 93 
19.1 
Premature Termination of the Study .................................................................................. 93 
19.2 
Investigator/study site termination or suspension ............................................................. 93 
19.3 
Investigator/EC Termination of Participation ..................................................................... 94 
 References ....................................................................................................................... 94 
 Version History ................................................................................................................. 96 
 

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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 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 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 
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.  
 
 

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Extended hospitalization 
Extended hospital stay or re-hospitalization that is related to the 
procedure or device that is not: 
• a planned hospitalization for a pre-existing condition, or procedure 
required by the Clinical Investigational Plan (including repeat 
ablation procedure), without serious deterioration in health.    
• hospitalizations due to recurrent AF/AT/AFL or prolonged 
hospitalization during the 30 days following procedure to adjust 
anticoagulation or anti-arrhythmia regimen or to administer 
diuretic medication. 
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. 
Heart block 
Damage to the heart’s electrical system that controls heart rhythm. 
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 
(PeAF)  
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. 

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Significant Pericardial 
Effusion 
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. 
Source Data 
Original records (or certified copies) of clinical findings, information, 
observations, or other activities in an investigation 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 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 
pericardiocentesis, 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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External 
Organizations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
          
 
Indication 
under 
investigation  
Current indication in the US: 
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 RF generator and accessories (DiamondTemp catheter-to-RF 
generator cable, DiamondTemp GenConnect cable, DiamondTemp EGM cable, 

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DiamondTemp irrigation pump, DiamondTemp irrigation tubing set) and compatible 
mapping system. 
 
Indication under investigation for the US and Canada:  
The DiamondTemp Catheter is indicated for use in cardiac electrophysiological 
mapping (stimulation and recording) and for treatment of drug refractory, 
symptomatic persistent 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. 
 
The indication under investigation is within the approved indication in 
Europe. 
Investigation 
Purpose 
The purpose of this study is to demonstrate the safety and effectiveness of the 
DiamondTemp Ablation System for the treatment of drug refractory, symptomatic 
persistent Atrial Fibrillation. 
Product 
Status 
The DiamondTemp™ Cardiac Ablation System (unidirectional and bidirectional 
catheters, the RF Generator, Irrigation Pump, and its accessories) (see Figure 7) is  
market-released in the US and will become investigational when used as indicated in 
the study in the US. The DiamondTemp System is market released and will be used 
within the approved indications in Europe, therefore, is not considered 
investigational for the intended patient population in Europe. The DiamondTemp 
Ablation components will be considered investigational in geographies (Canada) in 
which the product is not available commercially and will be labeled for exclusive use 
in Clinical Investigations.   
Primary 
Safety 
Endpoint 
The primary safety endpoint is defined as freedom from a composite of serious 
adverse events (SAEs) occurring within 7 days, procedure and/or device-related 
significant pericardial effusion that occurs within 30 days and severe or clinically 
symptomatic pulmonary vein stenosis and atrioesophageal fistula through 6-months 
of the ablation procedure, as adjudicated by an independent Clinical Events 
Committee (CEC) for relatedness to the procedure or device. 
 
The primary safety device- or procedure-related SAE composite will be the combined 
rate of the following events:     
• Atrioesophageal fistula  
• Bleeding complication 
• Cardiac tamponade / perforation  
• Death 
• Extended hospitalization 
• Myocardial infarction  
• Pericarditis  
• Phrenic nerve paralysis 
• Pulmonary edema 
• Pulmonary vein stenosis 
• Significant Pericardial Effusion 

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• Stroke/CVA 
• Thromboembolism 
• Transient ischemic attack (TIA) 
• Vagal nerve injury  
• Vascular access complication 
Primary 
Effectiveness 
Endpoint 
Freedom from documented Atrial Fibrillation (AF), Atrial Flutter* (AFL) and Atrial 
Tachycardia (AT) 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: 
• Inability to electrically isolate all accessible targeted pulmonary veins during the 
ablation procedure. 
• Documented episodes of AF, AFL or AT lasting ≥30 seconds in duration as 
evidenced by electrocardiographic data during the effectiveness evaluation 
period. 
• DC cardioversion for AF, AFL or AT during the effectiveness evaluation period. 
• A repeat ablation procedure to treat AF, AFL or AT during the effectiveness 
evaluation period. 
• Use of a new or previously failed AAD at a dose greater than the highest 
ineffective dose for AF during the effectiveness evaluation period. 
• Use of a non-study device for ablation of any AF targets during the index or 
repeat ablation procedure during the blanking period. 
• More than one (1) repeat ablation procedure during the 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.    
Secondary 
Endpoints 
Secondary endpoints to characterize the performance of the DiamondTemp Ablation 
System 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 AF, AT and AFL* episodes during the effectiveness 
evaluation period lasting ≥30 seconds in duration by ECG monitoring. 
• Freedom from documented AF, AT and AFL* episodes during the effectiveness 
evaluation period in the absence of class I and III anti-arrhythmic drug therapy. 
• Rate of acute procedural success, defined as confirmation of electrical isolation of 
PVs at least 20 minutes following the last ablation around the respective PV.    
• Rate of single procedure success defined as the rate of subjects treated with one 
single ablation procedure during study participation and with freedom from 
documented AF, AT and AFL* at 12 months.  
• Rate of single procedure success defined as the rate of subjects treated with one 
single ablation procedure during study participation and with freedom from ALL 
primary effectiveness endpoint failure criteria.  

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• 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. 
 
*  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. 
Ancillary 
Endpoints 
Ancillary endpoints to further characterize the performance of the DiamondTemp 
Ablation System will include: 
• Procedure characteristics: 
o Total procedure time (minutes), defined as time of investigational catheter 
insertion into the vasculature to time of last procedural ablation catheter 
removed. 
o Total treatment device time (minutes), defined as time of delivery of first RF 
ablation with investigational catheter to removal of the investigational 
catheter. 
o Mean cumulative RF Time (minutes).     
o Mean duration of RF ablations (seconds). 
o Total fluid infused through the investigational catheter (mL). 
o Total fluoroscopy time (minutes). 
• Number of re-hospitalizations due to Atrial Fibrillation recurrence during the 
effectiveness evaluation period. 
Study Design 
The DIAMOND-AF II Study is a prospective, multi-center trial being performed at 
centers in the United States, Canada and Europe. A maximum of 376subjects will be 
enrolled at up to 30 centers in the United States (US), Canada, and Europe.  
Approximately 50% of the data will be generated from sites within the US. 
Inclusion/Excl
usion Criteria 
Inclusion Criteria:  
1. Above eighteen (18) years of age or of legal age to give informed consent 
specific to state and national law.  
2. Subjects with a history of documented symptomatic, persistent Atrial Fibrillation 
with 1) a physician’s note documenting a continuous AF episode lasting longer 
than 7 days but less than 12 months AND 2) two electrocardiograms from any 
form of rhythm monitoring showing continuous AF taken at least 7 days apart 
OR a 24-hour Holter within 180 days of the ablation procedure showing 
continuous AF. 
3. Refractory, intolerant or contraindicated to at least one Class I or III anti-
arrhythmic (AAD) drug for treatment of Atrial Fibrillation. 
4. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia. 
5. Subject agrees to comply with study procedures and be available (geographically 
stable) for follow-up visits for at least 12 months after enrollment. 
6. Subject is willing and able to provide written consent.  
 
Exclusion Criteria: 
At time of enrollment and/or prior to procedure: 

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1. Continuous AF >12 months (long-standing persistent AF). 
2. Paroxysmal AF with longest episode <7 days. 
3. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-
cardiac cause. 
4. Rheumatic heart disease. 
5. Severe mitral regurgitation. 
6. Hypertrophic cardiomyopathy. 
7. LA diameter >5.5 cm. 
8. Left ventricular ejection fraction (LVEF) <40%. 
9. Currently NYHA Class III or IV or exhibits uncontrolled heart failure. 
10. Body Mass Index (BMI) >42 kg/m2. 
11. LA ablation, septal closure device or mitral valve surgical procedure at any 
time prior to enrollment. 
12. Presence of intramural thrombus, tumor or abnormality that precludes 
vascular access, catheter introduction or manipulation. 
13. Coagulopathy, bleeding diathesis or suspected procoagulant state. 
14. Sepsis, active systemic infection or fever (>100.5o F / 38o C) within a week 
prior to the ablation procedure. 
15. Significant restrictive or obstructive pulmonary disease or chronic respiratory 
condition. 
16. Renal failure requiring dialysis or renal compromise that in the Investigator’s 
judgement would increase risk to the subject or deem the subject 
inappropriate to participate in the study. 
17. 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. 
18. Positive pregnancy test results for female subjects of childbearing potential 
or breast feeding. 
19. Enrollment in a concurrent clinical study that in the judgement of the 
Investigator would impact study outcomes. 
20. Acute or chronic medical condition that in the judgment of the Investigator 
would increase risk to the subject or deem the subject inappropriate to 
participate in the study. 
21. 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: 
22. Documented LA thrombus upon imaging. 
23. Creatinine >2.5mg/dl or creatinine clearance <30mL/min.     
Within 3 months of enrollment: 
24. Significant gastrointestinal (GI) bleed. 
25. Myocardial infarction (MI), unstable angina, cardiac surgery or coronary 
intervention. 
 
Within 6 months of enrollment: 
26. Coronary artery bypass graft (CABG) procedure.  
27. Implant procedure performed for ICD, CRT leads or pacemaker. 

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28. Documented stroke, CVA, TIA or suspected neurological event. 
 
Study 
Procedures 
and 
Assessments 
The initial focus of the ablation procedure is to create a series of radiofrequency (RF) 
lesions encircling the left and right PVs to achieve electrical pulmonary vein antrum 
isolation (PVI) from the rest of the left atrium (LA).  
 
Physicians will be allowed to consider additional ablation strategies per their current 
standard ablation practice and within the recommendations of the protocol. All 
subjects will be considered enrolled following review and signature on informed 
consent. For full details of procedures performed per visit, please see “Study 
Procedures” section. 
 
Follow-Up Visit Schedule:  
Subject Visit Description 
Timeframe / Visit Window 
Enrollment and Screening Visit(s) 
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  
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 
As needed/necessary 
Safety 
Assessments 
All adverse events will be collected starting at the time of signing the Informed 
Consent Form (ICF) through the duration of the subject’s participation in the study. 
In addition, any device deficiency related to the DiamondTemp Ablation System and 
associated accessories should be reported. 
 Statistics 
The primary safety and effectiveness endpoints will be analyzed using the Kaplan-
Meier method. The study will be considered successful when both the primary safety 
and the primary effectiveness objectives are met. 
 
Descriptive summary statistics for continuous variables will include the number of 
subjects, mean, standard deviation, median, quartiles and range. 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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 Introduction 
 
4.1 Background- 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] [4] [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] [7] [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] 
Episodes of AF that are continuous and sustained beyond 7 days but less than 12 months are classified 
as persistent AF (PeAF) according to the most recent 2017 HRS/EHRA Consensus Statement.  Long-
standing persistent AF is defined as continuous AF of greater than 12 months duration. [10] 
 
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. [11] [12] 
 
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. [13] 
 
4.1.1 
Prior Clinical Evidence for RF Ablation to Treat Persistent AF   
Catheter ablation is commonly performed for persistent AF (PeAF), but few high quality randomized 
controlled trials (RCTs) exist. [17] Multiple RF catheters have been approved for the treatment of 
paroxysmal Atrial Fibrillation, but to date there are no RF catheters approved in the United States 
specifically for the treatment of PeAF. 
 

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Following the approval of RF catheters for PAF, companies are now seeking approval for PeAF.  
Biosense-Webster is currently enrolling subjects in the PRECEPT study (NCT#02817776) to demonstrate 
safety and effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter in the treatment of drug 
refractory, symptomatic persistent Atrial Fibrillation. 
 
The optimal RF lesion set to treat PeAF is a controversial topic, but as demonstrated in a large RCT study, 
STAR-AF II (NCT#01203748), it was shown that PVI only may be as effective as other additional ablation 
strategies.  STAR-AF II randomly assigned 589 participants with PeAF in a 1:4:4 ratio to a) ablation with 
PVI only (67 patients), b) PVI plus ablation of electrograms (egm) showing complex fractionated activity 
(263 patients) or c) PVI plus additional linear ablation across the atrial roof and mitral isthmus (259 
patients) [18]. While there was a greater percentage of patients with no recurrent PeAF at 18 months in 
the PVI only group (59% vs. 49% and 46%, for the PVI plus complex fractionated egm or linear ablation, 
respectively) the study found that there was no reduction in the freedom from PeAF based on study 
ablation strategies. 
 
The DiamondTemp Ablation System was being evaluated in the DIAMOND-AF Study for the treatment of 
drug refractory, symptomatic paroxysmal Atrial Fibrillation (NCT#03334630). DIAMOND-AF was a global, 
multi-center, randomized clinical study to evaluate the DiamondTemp System in 480 subjects with 
paroxysmal Atrial Fibrillation.  The DIAMOND-AF study enrollment was completed in 2018.  
 
The Sponsor is initiating a study to pursue a US indication to demonstrate the safety and effectiveness of 
the DiamondTemp Ablation System for the treatment of persistent AF. The study will focus on PVI being 
the “cornerstone” of PeAF ablation but will allow physicians to consider additional ablation strategies 
per their standard ablation practice and within the recommendations of the protocol. 
 
The DiamondTemp Ablation System is designed to give operators direct measures of lesion creation (i.e. 
tissue - tip interface temperatures and local electrograms recordings that attenuate during ablation and 
lesion formation). 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 the catheter-tissue interface temperature at a pre-defined set point optimal for creating an 
effective lesion.  These features may prove to be beneficial in creating safe and effective RF ablation for 
the treatment of PeAF. 
 
4.1.2 
Summary Of First-In-Human Clinical Study (TRAC-AF) 
Epix Therapeutics conducted a multi-center First-In-Human clinical study, TRAC-AF, 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, NCT#02821351) study was a prospective, multi-center, single-arm feasibility study 
initiated in 2016 and conducted at four European investigational sites.   
 
Enrollment was conducted in two phases.  Phase 1 included enrollment of 38 subjects from January 
through March of 2016; Phase 2 included enrollment of an additional 34 subjects from June through July 

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2017.  A total of 72 subjects 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 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 two (2) SAEs (2.9%) through the 7-day safety endpoint and three (3) SAEs (4.3%) 
through the 30-day safety endpoint.  The primary effectiveness endpoint of acute procedural success 
was achieved in 100% of subjects.  Freedom from AF at 12 months post-procedure was 72.5%. 
 
4.1.3 
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] 
[10] Subjects received ablation using the investigational device which required electrical isolation of all 
clinically relevant pulmonary veins.  
 
4.1.4 
TRAC-AF Investigational Device 
The TRAC-AF investigational device was the DiamondTemp Ablation System.  The investigational device 
was used with a commonly available EP recording system, cardiac stimulator and mapping device, the 
St. Jude EnSite Velocity or Precision Cardiac Mapping System.  There were no control devices in the 
study. 
 
4.1.5 
TRAC-AF Clinical Endpoints 
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 Ablation System was assessed by 
evaluating the nature and frequency of SAEs and SADEs at 30 days post-procedure. 
 
Primary Effectiveness Endpoint: The effectiveness of the DiamondTemp Ablation 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 Ablation 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.  
 
4.1.6 
 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 

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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. 
 
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. Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular 
Filtration Rate (GFR) 3 with a GFR ≤29.  
5. Active gastrointestinal bleeding 
6. Active infection or fever (>100.5 ◦F/38 ◦C)  
7. Sepsis 
8. Cardiac surgery within the past two months. 
9. 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) 
10. Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg within the last 30 
days) 
11. Documented anaphylaxis during previous exposure to angiographic contrast media 
12. Uncontrolled congestive heart failure (NYHA1 Class III or IV) 
13. Unstable angina or acute myocardial infarction within the past three months 
14. Bleeding, clotting disorders, or known thrombosis 
15. Severe Peripheral vascular disease 
16. Uncontrolled diabetes 
17. Heart valve replacement 
18. Mitral clip (E-valve)  
19. Women who are of childbearing potential who are currently pregnant or not willing to use 
contraception for the duration of the study 
20. Active participation in another investigational protocol currently or the last 30 days 
21. Unable or unwilling to take anti-coagulants 
22. Unwilling or unable to comply with any protocol or follow up requirements 
 

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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 
± 
0.5 
Range 
50.2 
- 
53.1 
Temperature Set-Point† (°C) 
Mean ± SD 
58.1 
± 
1.6 
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 
± 
1.9 
Range 
43.3 
- 
52.5 
Max Impedance† (Ω) 
Mean ± SD 
134.7 
± 
31.2 
Range 
94 
- 
239 
Average Impedance† (Ω) 
Mean ± SD 
95.5 
± 
8.9 
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 
2:35 
± 
0:47 
Range 
1:25 
- 
4:35 
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, 51% of subjects) or confirming PVI after a 
minimum of 20 minutes (n=34, 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 two (2) SAEs (2.9%) through the 7-day safety endpoint and three (3) SAEs (4.3%) 
through the 30-day safety endpoint, as adjudicated by an independent CEC (Table 5). The primary 
effectiveness endpoint of acute procedural success was achieved in 100% of subjects.  
 
Table 5.  Summary of Primary Safety Endpoint (Analyzable Population) 

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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 or other neurological signs or 
symptoms consistent with stroke. 
 
Duration of a focal or global neurological deficit ≥24 hours; or <24 hours if 
therapeutic intervention(s) were performed (e.g., thrombolytic therapy or 
intracranial angioplasty); or available neuroimaging documents a new 
hemorrhage or infarct; or the neurological deficit results in death  
No other readily identifiable non-stroke cause for the clinical presentation 
(e.g., brain tumor, trauma, infection, hypoglycemia, peripheral lesion, 
pharmacological influences).^ 
 
Confirmation of the diagnosis by at least one of the following: neurology or 
neurosurgical specialist; neuroimaging procedure (MRI or CT scan or 
cerebral angiography); lumbar puncture (i.e., spinal fluid analysis 
diagnostic of intracranial hemorrhage.) 
 
Stroke will be determined by the consulting neurologist using diagnosis 
criteria above and subsequent neuroimaging procedure (MRI or CT scan or 
cerebral angiography). 
 
^ Subjects with non-focal global encephalopathy will not be reported as a 
stroke without unequivocal evidence based on neuroimaging studies. 
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. 
*Planned hospitalization for a pre-existing condition, or a procedure required by the Clinical Investigational Plan 
(including repeat ablation procedure), without serious deterioration in health, will not be included in the primary safety 
endpoint analysis. Hospitalizations due to recurrent AF/AT/AFL or prolonged hospitalization during the 30 days 
following procedure to adjust anticoagulation or anti-arrhythmia regimen or to administer diuretic medication are not 
considered part of the combined primary safety endpoint.   
 
5.2 Primary Effectiveness Endpoint 
The primary effectiveness endpoint is defined as freedom from documented Atrial Fibrillation (AF), 
Atrial Flutter* (AFL) and Atrial Tachycardia (AT) 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: 

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• 
Inability to electrically isolate all accessible targeted pulmonary veins during the ablation 
procedure. 
• 
Documented episodes of AF, AFL or AT lasting ≥30 seconds in duration as evidenced by 
electrocardiographic data during the effectiveness evaluation period. 
• 
DC cardioversion for AF, AFL or AT during the effectiveness evaluation period. 
• 
A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period. 
• 
Use of a new or previously failed AAD at a dose greater than the highest ineffective dose for AF 
during the effectiveness evaluation period. 
• 
Use of a non-study device for ablation of any AF targets during the index or repeat ablation 
procedure during the blanking period. 
• 
More than one (1) repeat ablation procedure during the 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.  
 
5.3 Secondary Endpoints 
Secondary endpoints to characterize the performance of the DiamondTemp Ablation System 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 AF, AFL* or AT episodes during the effectiveness evaluation period 
lasting ≥30 seconds in duration by ECG monitoring. 
• 
Freedom from documented AF, AT and AFL episodes during the effectiveness evaluation period 
in the absence of class I and III anti-arrhythmic drug therapy. 
• 
Rate of acute procedural success, defined as confirmation of electrical isolation of PVs at least 
20 minutes following the last ablation around the respective PV.    
• 
Rate of single procedure success defined as the rate of subjects treated with one single ablation 
procedure during study participation and with freedom from documented AF, AT and AFL* at 12 
months.  
• 
Rate of single procedure success defined as the rate of subjects treated with one single ablation 
procedure during study participation and with freedom from ALL primary effectiveness endpoint 
failure criteria. 
• 
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. 
 
* 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. 
 
5.4 Ancillary Endpoints 
Ancillary endpoints to further characterize the performance of the DiamondTemp Ablation System will 
include: 

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• 
Procedure characteristics 
o Total procedure time (minutes), defined as time of investigational catheter insertion into 
the vasculature to time of last procedural ablation catheter removed. 
o Total treatment device time (minutes), defined as time of delivery of first RF ablation with 
the investigational catheter to removal of the treatment catheter. 
o Mean cumulative RF Time (minutes).     
o Mean duration of RF ablations (seconds). 
o Total fluid infused through the investigational catheter (mL). 
o Total fluoroscopy time (minutes). 
• 
Number of re-hospitalizations due to Atrial Fibrillation recurrence during the effectiveness 
evaluation period. 
 
 Study Design 
The DIAMOND-AF II Study is a prospective, non-randomized (single-group assignment) 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 patients with persistent Atrial 
Fibrillation. 
 
This study will enroll up to 376 subjects diagnosed with persistent AF 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 expected that one investigational 
ablation catheter, and appropriate accessory components will be used for each enrollment. It is 
anticipated that approximately 50% of the subjects will be enrolled at centers within the United States, 
with enrollment anticipated to be completed in 2022. The maximum number of enrollments per site will 
be identified within each sites Clinical Trial Agreement (CTA), but should not exceed 20%. There is no 
minimum requirement for enrollment at each site. 
 
6.1 Duration 
It is the intent of the protocol that all subjects will be followed for a minimum of 12 months post 
procedure. 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.  
 
6.2 Rationale 
The DIAMOND-AF II study is a pivotal clinical study designed to demonstrate that the DiamondTemp 
Ablation system is safe and effective. Justification of design is both based on a clinical evaluation and 
aligned with risk assessment results. See Section 4 for further background information and evaluation of 
clinical data. See Section 6 for further background on the study design. 

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6.3 Study Oversight 
6.3.1 
Steering Committee 
The DIAMOND-AF II Steering Committee is comprised of senior clinical, medical and regulatory members 
of the Sponsor, as well as international physician investigator advisors. 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, the Sponsor remains 
responsible for all decisions related to any such requests in line with approved study agreements. 
 
 
Atul Verma, M.D., FRCPC FHRS 
Medical Director, Heart Rhythm Program 
Southlake Regional Health Centre 
Phone:  +1 905 953 7917 
Email: atul.verma@utoronto.ca 
 
Andrea Natale, M.D., FACC, FHRS  
Director, Electrophysiology 
Texas Cardiac Arrhythmia Institute at St. David’s Medical Center 
Email: Andrea.Natale@stdavids.com 
 
B. Judson Colley III, M.D., M.P.H. 
Cardiologist/Electrophysiologist 
Jackson Heart Clinic 
Email: jcolley@jacksonheart.com 
 
Frank Cuoco, M.D., MBA 
Director, Arrhythmia Research Center 
Trident Medical Center 
Email: Frank.Cuoco@hcahealthcare.com 
 
Josef Kautzner, M.D., PhD, FESC 
Director, Electrophysiology 
Institut klinické a experimentální medicíny (IKEM) 
Email: josef.kautzner@ikem.cz 
 
Usman R. Siddiqui, MD 
Diplomate American Board of Internal Medicine, Nuclear Cardiology, Cardiology and Cardiac 
Electrophysiology 
AdventHealth 
Email: Siddiqui.u@gmail.com 
 

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Figure 2a.  DiamondTemp Ablation Catheter, Unidirectional 
 
 
Figure 2b.  DiamondTemp Ablation Catheter, Bidirectional 
 
7.2.2 
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 DiamondTemp Irrigation Pump and serial output to an 
external monitor which can mirror the RF Generator front panel information such as temperature, 
power and impedance curves resulting during RF delivery. 
 
 
Figure 3.  DiamondTemp RF Generator, Front Panel Display 
 
7.2.3 
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 Generator or Irrigation Pump.  
 

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Figure 4.  DiamondTemp Irrigation Pump 
 
7.2.4 
DiamondTemp Tubing Set 
The DiamondTemp Tubing Set is a disposable, one-time use, one-piece tubing that connects the 
DiamondTemp Catheter to the DiamondTemp Irrigation Pump.  
 
7.2.5 
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 
 
7.2.6 
DiamondTemp 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.  
 
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. EnSite Velocity or Precision) GenConnect Box (Maestro/EPT) and to the 
DiamondTemp RF Generator. The cable is supplied non-sterile and contains no latex. 
 

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7.6 Product Return 
All potentially defective devices should be returned to Medtronic Sunnyvale EPIX for analysis when 
permissible by local laws and regulations. Returns will be facilitated by Medtronic field personnel. 
 
DiamondTemp Ablation System components and accessories are to be returned to Medtronic Sunnyvale 
EPIX by each study site as described below:   
If no device deficiency, devices can be destroyed/disposed according to local laws and regulations. 
Unused investigational devices should be returned as described in the notes below: 
• 
 
 
 
 
 
Note: For DiamondTemp Ablation system accessories shipped to sites as investigational, unopened or 
expired accessories are required to be returned to Medtronic Sunnyvale EPIX. For accessories only 
considered investigational upon opening per the CIP there is no requirement to return unopened product 
to Medtronic Sunnyvale EPIX.  
  
7.7 Product 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 Principal Investigator or his/her authorized representative is responsible to keep records 
documenting the receipt and tracking of the investigational device at their site. A form will be provided 
to the site that will log the received by date, received by name, model/lot/serial numbers, and 
expiration dates as applicable for each device. 
 
 
 
  
 
 Study Site Requirements 
 
8.1 Investigator/Investigation Site Selection 
All Investigators managing the subject’s Atrial Fibrillation must be qualified practitioners and 
experienced in the diagnosis and treatment of subjects with Atrial Fibrillation. All physicians must be 
experienced and/or trained in the handling of DiamondTemp Ablation System.  
 
The role of the Principal Investigator is to implement and manage the day-to-day conduct of the Clinical 
Investigation as well as ensure data integrity and the rights, safety and well-being of the subjects 
involved in the Clinical Investigation. 
 
The Principal Investigator shall: 
• 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the Clinical Investigation (in accordance with the applicable requirements). 

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• 
Be experienced in the field of application and training in the use DiamondTemp Ablation 
System.  
• 
Disclose potential conflicts of interest, including financial, that interfere with the conduct of the 
Clinical Investigation or interpretation of results. 
• 
Be able to demonstrate that the proposed investigational study site: 
o Has the required number of eligible subjects needed within the recruitment period. 
o Has one or more qualified investigators, a qualified investigational study site team and 
adequate facilities for the foreseen duration of the Clinical Investigation. 
 
8.2 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 and ISO14155:2020, 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 Subject 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. 
• 
PI shall be able to demonstrate that the proposed investigation site has an investigation site 
team that is: qualified by education, training and experience to assume responsibility for the 
proper conduct of the Clinical Investigation in accordance with this standard and the applicable 
national regulations. 
• 
PI is responsible for ensuring adequate training and qualification of the investigation site team 
and for maintaining oversight of their activities. The PI may delegate tasks to qualified members 
of the investigation site team but retains responsibility for the Clinical Investigation. This also 
applies when activities are outsourced to an external organization by the PI in which case, 
he/she shall implement procedures to ensure the integrity of all tasks performed and any data 
generated by this external organization. 

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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.  
• 
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. 
 
8.3 Study Site Activation 
A Site Activation Letter is an official letter confirming that an Investigative site can begin enrolling 
subjects in the Clinical Investigation. Prior to sending a site the letter, Study Management will verify the 
Investigative site and Investigator have completed the following: (1) Protocol Training; (2) Device 
Training; (3) Site Initiation ctivities  , (4) signed Clinical Study Agreement, (4) appropriate national, 
international, and Regulatory approvals are received, including an approved Informed Consent Form and 
(5) a Site Activation Checklist has been completed.  
 
Once all documents are complete and training has been conducted, Study Management will send the 
Investigator a Site Activation Letter to verify that they may begin treating and enrolling subjects in the 
Clinical Investigation.  
 
8.4 Role of Sponsor Representative 
In addition to performing monitoring and auditing activities, Sponsor representatives may provide 
support at the study site as required for the study under supervision of the Principal Investigator, 
including: 
• 
Study training relevant and pertinent to the involvement of personnel conducting study 
activities and Investigator responsibilities. 
• 
Technical support at all visits, but no CRF data entry shall be performed by Sponsor personnel. 
 
In addition, for this study, sponsor representatives may be authorized by the Principal Investigator to 
perform the following significant trial related duties:  
• 
Support study Investigators in performing the study ablation procedure. 
• 
Support data collection during the ablation procedure. 
 
Any data collection completed by Medtronic personnel will be clearly identified as such. 
 
 Selection of Subjects 
 
9.1 Study Population 
Subjects included in the DIAMOND-AF II study should be selected from the general patient population 
indicated for or currently scheduled for catheter ablation of persistent AF.  
 
9.2 Subject Enrollment 
Subjects who meet general eligibility for consideration in the study will sign an informed consent and 
undergo a baseline evaluation.  All subjects will be considered enrolled following review and signature 

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on informed consent. The date the subject signed the IC, and the process for which signature was 
obtained, must be documented in the subject’s medical records. Investigators are responsible for 
ensuring that subjects meet all of the inclusion criteria and none of the exclusion criteria.  Institutional 
Review Board or Ethics Committee approval of the DIAMOND-AF II protocol and informed consent form 
must be obtained prior to enrolling subjects in the study.   
Sites should maintain a subject screening log to document subjects evaluated for enrollment into the 
study that did not consent.  A reason for ineligibility or not providing consent should be provided.  
Subjects who meet general eligibility for consideration in the study will sign an informed consent and 
undergo a baseline evaluation.  
 
9.3 Inclusion Criteria 
Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF II study:  
1. Above eighteen (18) years of age or of legal age to give informed consent specific to state and 
national law.   
2. Subjects with a history of documented symptomatic, persistent Atrial Fibrillation with 1) a 
physician’s note documenting a continuous AF episode lasting longer than 7 days but less than 
12 months AND 2) two electrocardiograms from any form of rhythm monitoring showing 
continuous AF taken at least 7 days apart OR a 24-hour Holter within 180 days of the ablation 
procedure showing continuous AF. 
3. Refractory, intolerant or contraindicated to at least one Class I or III AAD for treatment of Atrial 
Fibrillation.  
4. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia. 
5. Subject agrees to comply with study procedures and be available (geographically stable) for 
follow-up visits for at least 12 months after enrollment. 
6. Subject is willing and able to provide written consent. 
 
9.4 Exclusion Criteria 
Candidates will be excluded from the DIAMOND-AF II study if any of the following conditions apply 
within the following timeframes: 
 
At time of enrollment and/or prior to procedure: 
1. Continuous AF >12 months (long-standing persistent AF). 
2. Paroxysmal AF with longest episode <7 days. 
3. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause. 
4. Rheumatic heart disease. 
5. Severe mitral regurgitation. 
6. Hypertrophic cardiomyopathy. 
7. LA diameter >5.5 cm. 
8. Left ventricular ejection fraction (LVEF) <40%. 
9. Currently NYHA Class III or IV or exhibits uncontrolled heart failure. 
10. BMI >42 kg/m2. 
11. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment. 
12. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter 
introduction or manipulation. 
13. Coagulopathy, bleeding diathesis or suspected procoagulant state. 

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14. Sepsis, active systemic infection or fever (>100.5oF / 38oC) within a week prior to the ablation 
procedure. 
15. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. 
16. Renal failure requiring dialysis or renal compromise that in the Investigator’s judgement would 
increase risk to the subject or deem the subject inappropriate to participate in the study. 
17. 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. 
18. Positive pregnancy test results for female subjects of childbearing potential or breast feeding. 
19. Enrollment in a concurrent clinical study that in the judgement of the Investigator would impact 
study outcomes. 
20. Acute or chronic medical condition that in the judgment of the Investigator would increase risk 
to the subject or deem the subject inappropriate to participate in the study. 
21. 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: 
22. Documented LA thrombus upon imaging. 
23. Creatinine >2.5mg/dl or creatinine clearance <30mL/min.    
  
Within 3 months of enrollment: 
24. Significant gastrointestinal (GI) bleed. 
25. Myocardial infarction, unstable angina, cardiac surgery or coronary intervention. 
 
Within 6 months of enrollment: 
26. Coronary artery bypass graft (CABG) procedure.   
27. ICD, CRT leads or pacemaker implant procedure. 
28. Documented stroke, CVA, TIA or suspected neurological event. 
 
 Study Procedures 
Prior to performing study related procedures, all sites must have Ethics Committee (EC) and associated 
regulatory authority approval if applicable (e.g., Competent Authority approval) as well as 
documentation from the Sponsor of site readiness. Site personnel training will be completed prior to 
participation in this clinical study. In addition, all participating site staff must be trained on their 
respective aspects of the study and must be delegated by the Principal Investigator to perform study 
related activities. Study materials will be provided to site staff after site readiness. 
 
Sponsor personnel may provide technical support, including completion of a Sponsor Technical Support 
List , during the ablation procedure. 
 
10.1 Schedule of Events 
Schedule of Events is outlined in Table 8 below.  
 

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6 Month Follow-Up 
180 ± 28 days 
12 Month Follow-up 
365 ± 45 days 
Unscheduled Visits 
As needed/necessary 
Repeat Ablation Procedure 
As needed/necessary 
 
10.4 Subject Screening 
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 prior to 
insertion of the investigational catheter.  
• 
Intent-to-Treat: Includes all subjects who sign ICF and attempt the study treatment.  
• 
Modified Intent-to-Treat: Includes all subjects who sign ICF, meet eligibility criteria, and attempt 
the study treatment. 
• 
Treatment-Per-Protocol: Includes all subjects who sign ICF, meet eligibility criteria, and attempt 
the study treatment, without any major protocol deviations. 
 
The statistical analysis for each classification will be documented in the Statistical Analysis Plan (SAP). 
 
10.4.1 
Subject Consent 
An Informed Consent Form (ICF) is used to protect the rights and welfare of subjects in a Clinical 
Investigation. Informed consent (IC) is defined as a legally effective documented confirmation of a 
subject’s (or their legally authorized/designated representative or guardian, only applicable for US & 
Canada) voluntary agreement to participate in a particular study after information has been given and 
explained to the subject on all aspects of the study that are relevant to the subject’s decision to 
participate. This process includes obtaining an Informed Consent Form (ICF), and an Authorization to 
Use and Disclose Personal Health Information that has been approved by the study site’s EC and signed 
and dated by the subject (or their legally authorized/designated representative or guardian). A subject 
may only consent after information has been given and explained to the subject on all aspects of the 
Clinical Investigation that are relevant to the subject’s decision to participate. IC may be given by the 
legally authorized/designated representative only if a subject is unable to make the decision to 
participate in a Clinical Investigation. In such cases, the subject shall also be informed about the Clinical 
Investigation within his/her ability to understand. 
 
Prior to enrolling subjects, the IC and the Authorization to Use and Disclose Personal Health Information 
form must be approved by the EC.  The document(s) must be controlled (i.e. versioned and/or dated) to 
ensure it is clear which version(s) were approved by the EC.  Any adaptation of the sample IC must be 
reviewed and approved by the Sponsor and the EC reviewing the application prior to enrolling subjects.  
 
The Investigator must notify the subject (or their legally-authorized/designated representative or 
guardian) of any significant new findings about the study that become available during the course of the 
study which are pertinent to the safety and well-being of the subject, as this could impact a subject’s 

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willingness to participate in the study. If relevant, consent may be requested from subjects to confirm 
their continued participation. 
 
Prior to initiation of any study-specific procedures, IC must be obtained from the subject (or their legally 
authorized/designated representative or guardian). Likewise, privacy or health information protection 
regulation may require subjects to sign additional forms to authorize study sites to submit subject 
information to the study sponsor. The IC process must be conducted by the Principal Investigator or an 
authorized designee, and the ICF and an Authorization to Use and Disclose Personal Health Information 
form must be given to the subject (or their legally authorized/designated representative or guardian) in 
a language he/she is able to read and understand. The process of IC must be conducted without using 
coercion or undue improper influence on or inducement of the subject to participate by the Investigator 
or other study site personnel. The IC process shall not waive or appear to waive subject’s legal right. The 
language used shall be as non-technical as possible and must be understandable to the subject and the 
impartial witness, where applicable.  
 
The subject must have ample time and opportunity to read and understand the ICF, to inquire about 
details of the study, and to decide whether or not to participate in the study. All questions about the 
study should be answered to the satisfaction of the subject. 
 
When the subject decides to participate in the study, the ICF must be signed and personally dated by the 
subject and Investigator or authorized designee, as required by the ICF, and ensured by the Principal 
Investigator or his/her authorized designee.  
 
A copy of the ICF and the Authorization to Use and Disclose Personal Health Information, signed and 
dated as required by law, must be provided to the subject and his/her authorized designee.  
 
If the ICF is obtained the same day the subject begins participating in study-related procedures, it must 
be documented in the subject’s case history that consent was obtained prior to participation in any 
study-related procedures. It is best practice for the IC process to be documented in the subject’s case 
history, regardless of circumstance. 
 
In the event the subject cannot read and/or write, witnessed (impartial witness) IC will be allowed, 
provided detailed documentation of the process is recorded in the subject’s case history and the witness 
signs and dates the IC.  The IC should document the method used for communication with the 
prospective subject and the specific means by which the prospective subject communicated consent to 
participate in the study.  
 
In the event the subject or legally designated representative cannot read and/or write, the IC process 
shall be obtained through a supervised oral process. An independent and impartial witness must be 
present during this process. The IC and any other information must be read aloud to the prospective 
subject or his/her legally designated representative. Whenever possible, either the subject or his/her 
legally designated representative shall sign and personally date the informed consent form. The witness 
signs and personally dates the IC attesting that the information was accurately explained and that 
informed consent was freely given. 
 

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The template IC will be provided under separate cover. The original of the signed ICF must be filed in the 
hospital/clinical chart and/or with the subject’s study documents.  
 
The ICF and Authorization to Use and Disclose Personal Health Information must be available for 
monitoring and auditing. Any Sponsor personnel who support the study procedure must be able to 
review the subject’s signed and dated ICF and verify its completeness prior to proceeding with the 
procedure. In the event the Sponsor field personnel identify IC as being incomplete, the study procedure 
will not be allowed to occur until the consent of the subject can be adequately and appropriately 
obtained.  
 
10.5 Enrollment and Baseline 
When a patient signs and dates the consent form, he/she is considered a subject enrolled in the study. A 
log of all subjects enrolled in the study should be maintained. 
 
The following evaluations will be performed after consent, unless previously performed as part of 
routine clinical evaluations within the specified windows: 
 
Within 6 months prior to the procedure: 
• 
Transesophageal or transthoracic echocardiography (TEE or TTE)  
o to determine LA diameter and % LVEF 
 
Following Consent but prior to the interventional procedure date 
• 
Assessment of all factors specified for evaluation in Inclusion and Exclusion criteria 
• 
Medical History  
• 
Physical Exam 
• 
Review cardiovascular medication history  
o Concomitant antiarrhythmic medication and anticoagulation   
• 
Review of arrhythmia symptoms, occurrences, history 
• 
NIH Stroke Scale  
o Administered by staff member certified to conduct assessment 
• 
AF Quality of Life Survey (AFEQT Questionnaire version 1.0) 
 
Within 7 days prior to the procedure 
• 
Pregnancy Screen 
o Women of child bearing potential will be required to have documentation of a negative 
pregnancy test conducted within 7 days prior to the study procedure. 
 
Within 48 hours prior to the procedure: 
• 
TEE or ICE (for subjects who cannot undergo TEE)  
o to rule out LA thrombus in subjects that meet any one of the following criteria: 
▪ CHA2DS2-VASc score is ≥2 
▪ LA diameter ≥4.6 cm 
▪ Pre-procedure anticoagulation requirements are not met 
o Not currently and adequately anticoagulated for 3 weeks or longer 

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▪ 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 
  
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 and must be withdrawn. 
 
10.6 Procedure 
The majority of procedures and assessments will be performed per routine practice at participating 
institutions. However, some protocol requirements may not align with a sites routine practice. The 
protocol required scheduled follow up cadence may not align with or be more frequent than routine 
practice at some participating sites. 
 
10.6.1 
Pre-Ablation Requirements 
• 
Anti-arrhythmic drugs (AADs) 
o Discontinuation of AADs prior to the procedure is left to the discretion and practice of the 
Investigator and investigational site best practices.   
o Amiodarone use must be discontinued at least 7-14 days prior to the ablation procedure 
and not restarted after the ablation procedure.    
• 
Anti-coagulation therapy  
o Performance of the ablation procedure on uninterrupted anti-coagulation therapy (e.g. 
warfarin or NOACs) is strongly recommended. 
o For subjects anticoagulated with a NOAC prior to AF catheter ablation, it is reasonable to 
hold one to two doses of the NOAC prior to AF ablation with re-initiation post-ablation. 
• 
Pregnancy screen 
o 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 study procedure. 
o  
10.6.2 
Ablation Procedure 
Pre-procedural Preparation 
• 
Subjects that meet the eligibility and pre-ablation requirements will be prepped for the ablation 
procedure.  The procedures will follow standard hospital practice but should, at a minimum, 
include the following: 
o Prep and sedate subject per institutional standard practice. 
▪ Method of sedation will be recorded (i.e. conscious sedation or general anesthesia). 
▪ Placement of an esophageal temperature probe to guide energy delivery on the 
posterior wall is strongly recommended.  
• 
An esophageal temperature increase of 1 – 2 °C from baseline or a recorded 
temperature of 39 – 40 °C should trigger interruption of RF energy delivery. Care 
should be taken to ensure that the esophageal temperature probe is aligned as 

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close as possible with the position of the ablation catheter during ablation to 
avoid a false impression of safety.  
• 
Deviation of the esophageal temperature probe is allowed if standard practice at 
the institution. 
▪ Place Ensite Velocity or Precision patches on subject per IFU. 
▪ Place commercially available dispersive indifferent electrode (DIP) patch on subject.  
o Gain vascular access per lab protocol via the femoral veins and/or right or left internal 
jugular or subclavian veins by insertion of sheaths.  
o Any commercially available 8.5F, fixed or steerable, sheath may be used. 
▪ A steerable sheath is recommended to be used with the DiamondTemp Ablation 
Catheter. 
o Aspirate and flush sheaths with heparinized saline to remove air prior to introduction into 
the body and catheter insertion. 
▪ Sheaths (fixed or steerable) should be continuously infused with heparinized saline at 
1-2ml/min throughout the procedure. 
o Complete a single or double transseptal puncture to access the LA. 
o 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. 
▪ ACT must be ≥250 seconds prior to first ablation and should be maintained at >300 
seconds throughout the procedure.   
▪ ACT levels should be checked every 20-30 minutes during the ablation procedure.  
▪ If ACT is <300 seconds during ablation procedure, more heparin should be 
administered.  
o Insert and place multi-electrode diagnostic catheters under fluoroscopic guidance. 
▪ Placement of intracardiac catheters will be per standard lab practice but must include 
a coronary sinus (CS) catheter and a multi-electrode catheter for PV mapping and 
verification of PV isolation and entrance block. 
o Create a 3D anatomical map of the left atrium and location of the PVs with a multi-
electrode catheter using Ensite Velocity or Precision system. 
▪ RF applications and location will be added to the map during the procedure per site 
standard practice. 
o A pre-ablation EGM/12 lead ECG documenting the subject’s rhythm at the beginning of the 
procedure will be collected. 
o 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 devices must be reported 
on the Device Deficiency CRF.  The use of a replacement (back-up) device should be 
indicated on the Procedure CRF. 
 
DiamondTemp Ablation System Set-up 
The DiamondTemp Ablation System 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 10. 
 
 

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esophagus it is highly recommended that Investigators use an esophageal temperature probe during RF 
ablation procedures to monitor esophageal temperature and help guide energy delivery.  An esophageal 
temperature increase of 1-2 °C from baseline or a recorded temperature of 39°C–40 °C should trigger 
interruption of RF energy delivery [10]. Care should be taken to ensure that the esophageal temperature 
probe is aligned as close as possible with the position of the ablation catheter during ablation to avoid a 
false impression of safety. Additionally, 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 is encouraged but is left to the discretion of the Investigator. 
 
Procedural Recommendations  
• 
PVI must be confirmed and documented by entrance block of potentials into the PV a minimum 
of 20 minutes following the last RF application of the initial PVI in each PV or PV pair to monitor 
for PV reconnection.  
• 
Adenosine may be administered following PVI to detect for the presence of dormant PV 
conduction. 
• 
Administration of isoproterenol to identify non-PV triggers is allowed.  
• 
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.  
• 
Empiric targeting of rotors, ganglionated plexi or performing ablation on posterior wall or LA 
roof is allowed and will be documented.  
• 
Spontaneously-occurring atrial arrhythmias that present during the procedure are allowed to be 
ablated at the Investigator’s discretion. CTI-dependent (typical) Atrial Flutter is also allowed if 
the subject has a known history of typical Atrial Flutter.  
• 
Investigator’s may also perform a CTI line prophylactically if it is their standard practice. 
• 
Investigators are discouraged from ablating the mitral lines unless there is a specific flutter that 
has to be ablated.   
• 
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 catheter 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: 
a. Catheter lot/serial number(s) used  
b. Temperature set point 
c. Power set point 
d. Total number of RF applications for PVI 
e. Total number of RF applications for non-PVI targets 

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f. Total RF time during the procedure 
g. Total number of ablations total 
h. Total fluid infused from the ablation catheter 
i. 
Presence of char or coagulum formation and incidence(s) of steam pops 
j. 
Procedure and fluoroscopy times  
 
If at any time during the ablation procedure the Investigator is unable to continue the ablation with the 
investigational 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 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 Anticoagulation 
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 
HRS Expert Consensus Statement on Catheter and Surgical Ablation of AF [10], regardless of the 
apparent success or failure of the AF ablation procedure.   
• 
Additionally, the Investigator’s decision regarding continuation of systemic anticoagulation more 
than 60 days post ablation should be based on the subject’s stroke risk profile (CHA2DS2-VASc 
score ≥2 in men and ≥3 in women, prior stroke or TIA and/or age ≥75 years) and not on the 
perceived success or failure of the ablation procedure. 
 
Post-Procedure AADs 
• 
If AADs are restarted following the ablation procedure, it is recommended to maintain subjects 
on a drug regimen for a duration of 2 to 4 weeks to address symptoms or early recurrences of 
AF, AFL or AT during the post-ablation healing and stabilization phase.  
• 
If AADs are restarted for clinical reasons during the blanking period but not later than the 3-
month follow-up visit, it is recommended that subjects are maintained under the same AAD 
regimen throughout the effectiveness period (12-month follow-up). During the effectiveness 
evaluation period, physicians may discontinue an AAD, but may not add a new class or escalate 
an AAD. 
 
10.6.3 
Pre-Discharge Follow-Up Visit 
Prior to being discharged from the hospital, subjects will complete a pre-discharge visit.  The evaluation 
while in the hospital will include but is not limited to the following: 
 

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• 
Complete Physical Exam to assess for procedure related complications per investigational 
center’s standard of care including but not limited to: 
a. Vital signs (blood pressure, heart rate, respiration rate, temperature) will be obtained.  
b. Cardiovascular and pulmonary examination. 
c. Standard neurological assessment. 
d. Assessment of catheter insertion sites (both sides of the groin).  
• 
Assess the subject for any adverse events following ablation procedure. 
• 
Perform a 12-lead ECG.  
a. 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. 
• 
Record medication changes since ablation procedure. 
a. Cardiac, AAD, diuretic, or anticoagulation. 
 
Subjects will be discharged from the hospital when stable, per the Investigator’s discretion.  
 
10.7 Scheduled Follow-up Visits 
 
10.7.1 
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). 
o  Review event monitor data for recordings made due to symptomatic episodes of 
arrhythmias since the last follow-up. 
 
10.7.2 
One Month Follow-Up 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: 
• 
Perform a complete physical exam with vital signs and 12-lead ECG. 
o Cardiovascular and pulmonary examination. 
o Standard neurological assessment. 
o Assessment of catheter insertion sites (both sides of the groin) . 
• 
Administer a follow-up NIH Stroke Scale assessment. 
• 
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. 

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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. 
 
10.7.3 
Repeat Ablation Procedure (if applicable) 
It is expected that some subjects will have early recurrences of atrial arrhythmias (e.g. AF, AT, AFL) 
within the blanking period (~90 days following the ablation procedure). [19] Investigators may perform 
repeat ablation procedure in subjects with highly symptomatic or multiple early recurrences of atrial 
arrhythmias that cannot be controlled with antiarrhythmic therapy. [10] [20] Subjects with documented 
early recurrence during the blanking period are not being considered a primary effectiveness failure.  
 
The repeat ablation procedure during the blanking period must be performed with the investigational 
catheter. Prior to the repeat ablation procedure, subjects must meet the pre-ablation requirements 
described in this protocol.  Investigators must follow all procedural requirements defined in this 
protocol 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. 
 
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. Each Repeat Ablation Procedure and discharge will be documented in a CRF. Adverse 
Events for recurrent AF are not required to be collected for Repeat Ablation Procedures.  
 
Commercial devices are allowed for use during a Repeat Ablation Procedure that is performed after the 
Blanking Period (~90 days post index ablation procedure), and will also be documented in a CRF. 
 
10.7.4 
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). 
o Subjects who have experienced symptoms or adverse events suggestive of PV stenosis are 
required to receive a chest CT or MRI scan to rule out PV stenosis. 
• 
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 (if 
applicable). 
• 
Instruct subject to record twice-monthly 1-minute recordings as well as symptomatic events.  
• 
Subjects will be instructed on how to use the event monitor to capture 24-hour Holter reading 
and the data will be transmitted remotely to the Corelab. 
 

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10.7.5 
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). 
o Subjects who have experienced symptoms or adverse events suggestive of PV stenosis are 
required to receive a chest CT or MRI scan to rule out PV stenosis. 
o 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 (if 
applicable) since the last follow-up and the event monitor data from the two (2) required 
monthly recordings. 
• 
Subjects will be instructed on how to use the event monitor to capture 24-hour Holter reading 
and the data will be transmitted remotely to the Corelab. 
• 
Administer a follow-up AFEQT Questionnaire (QOL). 
 
10.7.6 
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). 
o Subjects who have experienced symptoms or adverse events suggestive of PV stenosis are 
required to receive a chest CT or MRI scan to rule out PV stenosis. 
o 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 (if 
applicable) since the last follow-up and the event monitor data from the two (2) required 
monthly recordings. 
• 
Subjects will be instructed on how to use the event monitor to capture 24-hour Holter reading 
and the data will be transmitted remotely to the Corelab.  
• 
Administer a follow-up QOL assessment (AFEQT Questionnaire). 
• 
Administer a follow-up NIH Stroke Scale assessment. 
 
10.7.7 
Alternative Methods for Follow-Up Visits 
Alternative methods of data collection may be necessary in the case of extenuating circumstances, such 
as a global pandemic, when subjects are prohibited from coming into the office for required 
assessments. These are listed below as “alternative processes used only during extenuating 
circumstances”. Data unable to be collected remotely or via an alternative method should be collected 
at the next possible in-person visit. 

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In the event a subject is unable to return for an in-office follow-up visit, the alternative methods of 
obtaining follow-up assessments include virtual visit and/or phone visit. The study assessments which 
may not be feasible to be completed via the alternative methods are listed below: 
 
1. Virtual Visit, i.e. inclusive of video with study subject.  
The following assessments may not be (fully) completed with a virtual visit: 
• 
Physical examination (limited review per physician discretion). 
• 
Chest CT or MRI scan to rule out PV stenosis*: 
o Make every effort to schedule in-person imaging as soon as possible. 
o When possible, the subjects could be referred to a local imaging center for assessment. 
Local imaging technicians would require study training and delegation prior to assessment. 
• 
NIH Stroke Scale assessment (limited review per physician discretion). 
 
2. Phone Visit, i.e. no video with the subject. 
The following assessments may not be (fully) completed with a phone visit: 
• 
Physical examination (limited review per physician discretion). 
• 
Chest CT or MRI scan to rule out PV stenosis*: 
o Make every effort to schedule in-person imaging as soon as possible. 
o When possible, the subjects could be referred to a local imaging center for assessment. 
Local imaging technicians would require study training and delegation prior to assessment. 
• 
NIH Stroke Scale assessment. 
 
* Subjects who have experienced symptoms or adverse events suggestive of PV stenosis are required to 
receive a chest CT or MRI scan to rule out PV stenosis. 
 
10.7.8 
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. 
 
10.8 Protocol Deviations 
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. The use of waivers for deviating from the Clinical Investigation Plan is prohibited, going forward 
the study will be executed under Medtronic procedures. 
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. 
 

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If a Clinical Monitor or Medtronic Representative becomes aware that an Investigator is not complying 
with the signed Investigator’s Agreement, the Clinical Investigational Plan, the requirements of 
ISO14155:2020 or other applicable regulations, or any conditions of approval imposed by the reviewing 
IRB/EC Committee, the 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 the Sponsor, unless this action 
would jeopardize the rights, safety or welfare of a subject. 
 
Protocol deviations will be analyzed by the 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, the Sponsor will implement 
appropriate corrective and preventive actions, including repeat training as deemed necessary. 
 
10.9 Subject Exit, Withdrawal or Discontinuation 
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, lost to follow-up or death, etc.  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. At the 
time of study exit, all adverse events with an outcome of ongoing must be reviewed by the Investigator 
to determine a final status of the event.  Data collected up to the point of subject withdrawal may be 
used. 
 
10.10 
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). Subjects will be followed by standard of care after Clinical Investigation has been 
completed. 
 
10.11 
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 

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the Study Completion Form when a subject is lost to follow-up. When subjects are lost to follow-up the 
Investigator will make efforts to confirm the vital status of the subject. If allowed per local regulations, a 
person identified by the subject is informed of the possibility to be contacted by the principal 
investigator regarding how to reach the subject and the subject’s health status and a civil register may 
be contacted by the principal investigator to inquire about the subject’s whereabouts.   
 
 Risks and Benefits 
 
11.1 Potential Risks 
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 Ablation System are 
similar to 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.  A risk analysis for the DIAMOND-AF II has been performed in 
accordance with ISO 14971, and will ensure that the level of risk is acceptable throughout the duration 
of the study.   
 
Specific risks are outlined in the system labeling and Investigator Brochure, 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 
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 

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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 
d. Sepsis 
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. 

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d. Anesthetic reactions: including respiratory difficulties, sedation induced apnea, 
pneumonia, low blood pressure, cardiac arrest (death) and nausea and/or vomiting. 
 
11.2 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 any findings of risk that would be considered intolerable to the subject or user. 
The potential risks associated with any ablation procedure include standard surgical risks such as 
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 system allows for the 
measurement of tissue interface temperature and the RF 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. 
 
Risks associated with the DIAMOND-AF II 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 the Sponsor with data and information as required by this protocol.  
  
Additionally, extensive in vitro bench and in vivo animal studies have been successfully performed with 
the DiamondTemp Ablation System. Design verification and validation testing has been completed. Lot 
release testing is performed for all components of the system. 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, the Sponsor has 
determined that the benefits of the system 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. 
 

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11.3 Potential 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 persistent Atrial Fibrillation.   
 
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 Ablation 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 and c) utilize a low irrigation flow rate 
for all power output up to 50 Watts.   
 
11.4 Risk-Benefit Rationale 
The Risk-Benefit Rationale is provided within the current Investigator Brochure, and all subsequent 
versions.  
 
 Adverse Events and Device Deficiencies 
 
12.1 Adverse Events 
For the purposes of the study, all Adverse Events (AEs) will be collected starting at the time of signing 
the Informed Consent Form through the duration of the subject’s participation in the study. This 
includes 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.   
 
12.2 Device Deficiency 
Device deficiency (DD) information will be collected throughout the study and reported to the Sponsor, 
as per Table 13.   
 
Device deficiencies related to the investigational ablation system 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 

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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 DD is associated with an AE 
that specific event would be recorded as an AE. Refer to table 13 for Device Deficiency Reporting 
requirements. 
 
Note: Any Device Deficiency that might have led to a SADE 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 the Sponsor. 
 
12.3 Definitions/Classifications 
Where the definition indicates “device”, it refers to any device used in the study. This might be any 
component of the system under investigation, or any market released component or accessory of the 
system. Adverse Events (AE) will be classified according to the definitions below.  
 

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Unanticipated Adverse Device 
Effect (UADE) 
Any serious adverse effect on health or safety 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 a nature, severity, or degree of incidence in the Clinical 
Investigational Plan or application (including a supplementary plan 
or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare 
of subjects. (21 CFR 812.3(s)) 
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the current risk 
assessment.   
 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an 
effect which by its nature, incidence, severity or outcome has been 
identified in risk assessment.  
(ISO14155:2020, 3.51) 
Serious Health Threat 
Signal from any adverse event or device deficiency that indicates an 
imminent risk of death or a serious deterioration in the health in 
subjects, users or other persons, and that requires prompt remedial 
action for other subjects, users or other persons. 
 
NOTE 1: This would include events that are of significant and 
unexpected nature such that they become alarming as a potential 
serious health hazard or possibility of multiple deaths occurring at 
short intervals.  
(ISO14155:2020, 3.46) 
 
12.4 Reporting of Adverse Events 
Reporting of AEs to the Sponsor will occur on an AE CRF, including AE description, AE start date, 
seriousness, treatment, relatedness to the device and procedure and AE outcome.  Each AE must be 
recorded on a separate AE CRF.  
 
Planned hospitalization for a pre-existing condition, or a procedure required by the Clinical 
Investigational Plan, without serious deterioration in health, is not considered as part of the primary 
composite safety endpoint.  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/AT/AFL or prolonged hospitalization following procedure to adjust 
anticoagulation regimen or to administer diuretic medication are not considered AEs for this study. 
Adverse Events for recurrent AF are not required to be collected for Repeat Ablation Procedures.  
 
For any changes in status of a previously reported adverse event (i.e. change in treatment, outcome, 
relatedness), an update to the original AE must be provided.  All AEs must be followed until the AE has 
resolved, the subject exits the study or until study closure, whichever occurs first.  

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• 
Relatedness to device and procedure 
• 
In addition, the following source may be collected: 
o Death summary/hospital records (if available and allowed by state/local law) 
o Autopsy report (if available and allowed by state/local law) 
o Death certificate (if available and allowed by state/local law) 
 
12.6 Product Complaint Reporting 
In geographies where devices are market-released, product complaint reporting is applicable.  This 
includes when an AE is related to a market-released device during the study.  The reporting of product 
complaints is not part of the clinical study and should be done in addition to the Adverse Event and 
Device Deficiency reporting requirements.  Refer to local regulations for reporting requirements. 
Product Complaint: Any written, electronic or oral communication that alleges deficiencies related to 
the identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that 
has been placed on the market. 
 
It is the responsibility of the Investigator to report all product complaint(s) associated with a medical 
device distributed by the Sponsor, regardless whether they are related to intended use, misuse or abuse 
of the product. Reporting must be done immediately and via the regular channels for market-released 
products. 
 
The reporting of product complaints by the clinical team must be done according to the local Standard 
Operating Procedures. The Sponsor will notify the regulatory authorities (e.g. FDA) as applicable for the 
following incidents immediately upon learning of them: 
• 
Any malfunction or deterioration in the characteristics and/or performance of a device, as well 
as any inadequacy in the labeling or instructions for use which led or might have led to the 
death or serious deterioration in the state of health of a patient, user, or other person. 
• 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
• 
A serious deterioration in the state of heath includes: 
o Life-threatening illness or injury. 
o Permanent impairment of a body function or permanent damage to a body structure. 
o A condition necessitating medical or surgical intervention to prevent permanent impairment 
of a body function or permanent damage to a body structure. 
 
 Data Review Committees 
 
13.1 Data Safety Monitoring Board 
The purpose of the Data Safety Monitoring Board (DSMB) is to conduct 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 

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employees or shareholders of the Sponsor and they will not be a participating DIAMOND-AF II 
Investigator. 
 
The DSMB will be responsible to communicate any safety concerns, scientific concerns or other 
perceived concerns to the Sponsor 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 
suggested changes for the conduct of the trial. The Sponsor 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. 
 
13.2 Clinical Events Committee 
The purpose of the Clinical Events Committee (CEC) is to complete unbiased reviews and classification of 
SAEs and deaths reported by clinical study investigators. The CEC will consist of physicians who are not 
participating Investigators in the DIAMOND-AF II Study and who do not have any significant investment 
in the Sponsor or any of their entities. The three (3) voting members who serve on the CEC to provide 
independent, unbiased review and adjudication of clinical events throughout the trial will also be DSMB 
members. A complete description of CEC and DSMB responsibilities, qualifications, members and 
operating principles will be outlined in a combined charter. 
 
13.3 CRO/Core Lab(s) 
A designated contract research organization (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 24 hour Holter monitors.  
 
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 throughout 
the study.  Additionally, subjects will be required to collect 1-minute ECG recordings with their event 
monitor two times per month starting at the end of the blanking period to the 12-month follow up visit. 
Recordings made due to symptomatic episodes during the effectiveness evaluation period may count 
towards the scheduled, required monthly recordings. 
 
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 arrhythmia recurrence.  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 Lab’s 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. 
 
Subjects will be provided instructions on how to collect a 24 hour Holter reading with the event monitor 
provided for event monitoring during the 3, 6 and 12 months post-ablation procedure follow-up visit 
windows. 
 
The Core Lab will review, analyze and report on all event and Holter recordings as well as the 12-lead 
ECGs taken at the 3, 6 and 12-month follow-up visits. 

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 Statistical Design and Methods 
Before database lock, a Statistical Analysis Plan (SAP) will be prepared to provide full details of all 
planned analyses. The analyses presented here represent an outline of the intended methodology. Any 
change to the data analysis methods described in the Clinical Investigation Plan will require an 
amendment only if it changes a principal feature of the CIP. Any other change to the data analysis 
methods described in the CIP, and the justification for making the change, will be described in the 
clinical study report. 
 
14.1 Analysis Populations 
Three analysis populations are defined in this study: 
 
• 
The Intent-to-Treat (ITT) population will be comprised of all subjects who sign ICF and attempt 
study treatment (i.e. catheter inserted into vasculature).  
• 
The modified ITT (mITT) population will be a subset of the ITT population and comprised of all 
ITT subjects who meet eligibility criteria.  
• 
The Per-Protocol population will be a subset of the mITT population and comprised of all mITT 
subjects who do not have any major protocol violations (i.e. eligibility criteria violations, or 
ablation treatment with a non-study catheter for the index procedure or during blanking 
period). 
 
14.2 General Aspects of Analysis 
The DIAMOND-AF II study will be considered successful when both the primary safety objective and the 
primary effectiveness objective are met. For each objective, the sample size ensures a power of at least 
80% for a one-sided hypothesis test with alpha level of 0.025. 
 
The main analysis of the study objectives will be based on the modified Intent-to-Treat (mITT) 
population, which includes all subjects who sign informed consent, meet eligibility criteria, and attempt 
study treatment (i.e. catheter inserted into vasculature). Additionally, sensitivity analyses for the 
primary objectives will be conducted on the Per-Protocol population, which includes all mITT subjects 
who do not have any major protocol violations (i.e., eligibility criteria violations, or ablation treatment 
with a non-study catheter), and the ITT population, which includes all subjects who sign informed 
consent and attempt study treatment.  
 
The main analysis will include data from all contributing geographies. A poolability analysis will be 
performed by stratifying analysis of the primary objectives by geographical region and reporting results 
separately for each region. Similarly, poolability by age and gender will be assessed. 
 
The subjects’ baseline characteristics will be summarized for the mITT population with standard 
descriptive summary statistics, including counts and percentages for categorical variables, and mean, 
standard deviation, median, quartiles and range for continuous variables. Ordinal variables may be 
analyzed as if they were continuously scaled. Treatment characteristics and safety data will be 
summarized for the mITT population. 
 

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For the ITT population, subject disposition will be illustrated in a study flow diagram, and subject 
attrition will be identified and summarized. Subject visits will be tabulated and compliance to visit 
schedule will be summarized for the mITT population.  
 
For each of the objectives the available data will be summarized. The main analysis of the study 
objectives will be based on available data and missing data will not be imputed. For the primary safety 
and effectiveness objectives, a tipping point analysis will be performed to assess the potential impact of 
missing data. 
 
14.3 Analysis Execution 
A final clinical study report for the DIAMOND-AF II study will be prepared once all data collection has 
ended and all subjects have completed the 12-month follow-up visit or have been exited. The final 
clinical study report will be written within six (6) months of the database closure at the end of the study. 
Analyses will include all primary, secondary, and ancillary objectives. The final report will be signed by 
the global coordinating Investigator and provided to all study Investigators.  
 
14.4 Primary Objective(s) 
 
14.4.1 
Primary Safety Objective 
Primary Safety Objective 
To demonstrate that the primary safety event rate associated with the Diamond-Temp ablation system 
is lower than the pre-specified Objective Performance Criterion (OPC). 
 
Hypothesis 
H0: P ≥ P0 
H1: P < P0 
where P0 = 11.5% (Safety OPC), and lower event rates are better. 
 
Endpoint definition and derivation  
The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAEs) 
occurring within 7 days, procedure and/or device-related significant pericardial effusion that occurs 
within 30 days, and severe or clinically symptomatic pulmonary vein stenosis and atrioesophageal fistula 
through 6 months post-index ablation procedure, as adjudicated by an independent Clinical Events 
Committee (CEC) for relatedness to the procedure or device. 
 
The primary safety device- or procedure-related SAE composite will be the combined rate of the 
following events: 
• 
Atrioesophageal fistula 
• 
Bleeding complication 
• 
Cardiac tamponade / perforation 
• 
Death 
• 
Extended hospitalization 
• 
Myocardial infarction 

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• 
Pericarditis 
• 
Phrenic nerve paralysis 
• 
Pulmonary edema 
• 
Pulmonary vein stenosis 
• 
Significant Pericardial Effusion  
• 
Stroke / CVA 
• 
Thromboembolism 
• 
Transient ischemic attack (TIA) 
• 
Vagal nerve injury 
• 
Vascular access complications 
 
Performance Requirements 
The null hypothesis will be rejected if the one-sided 97.5% upper confidence bound is lower than 11.5%. 
 
Rationale for Performance Criteria 
This performance goal was derived from a point estimate of 7% and a margin of indifference of 4.5%. 
This point estimate value was determined from a review of the FDA publicly available information 
combined with the published literature for all FDA approved medical device trials for Atrial Fibrillation 
treatment1 and some other studies2 on ablation treatment for Atrial Fibrillation.  Based on the Sponsor’s 
best estimations, the overall rates of SAEs reported in these studies ranged from 4.9% to 14.6%, while 
most IDE approved randomized trials were designed to allow for 8% to 10% non-inferiority margins. 
 
Analysis Methods 
The primary safety event rate will be analyzed using the Kaplan-Meier method. The components of the 
SAE composite endpoint will also be summarized to show the number and percentage of subjects 
meeting each component. 
 
Determination of Subjects/Data for Analysis  
The main analysis of the primary safety objective will be based on the mITT population, which includes 
all subjects who sign informed consent, meet eligibility criteria and attempt study treatment (i.e. 
catheter inserted into vasculature). Additionally, sensitivity analysis for the primary safety objective will 
be conducted on the Per-Protocol population, which includes all mITT subjects who do not have any 
major protocol violations (i.e., eligibility criteria violations, or ablation treatment with a non-study 
catheter), and the ITT population, which includes all subjects who sign informed consent and attempt 
study treatment. 
 
1 Reddy, et al. “Results of the TOCCASTAR Study,” Circulation. Aug. 10, 2015. DOI 10.1161 CirculationAHA 114.014092 
https://www.accessdata.fda.gov/cdrh docs/pdf13/P130026b.pdf  
Wilbur, et al. JAMA Vol. 303, No. 4. P333-340. 
https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030031S011b.pdf  
https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150026B.pdf 
Dukkipati, et al. JACC Vol 66. No.12, 2015. p1350-1360. 
https://www.accessdata.fda.gov/cdrh docs/pdf10/P100010b.pdf  
Natale, et al. JACC Vol.64, No.7, 2014. P 647- 656. 
 
2 Squara, et al. Europace (2015) 17, 718-724. 
Kuck, Karl-Heinz, et al. NEJM 374;23, June 9, 2016, 2235-2245. 
Chen, Yi-He et al. Europace (2017) 19, 784-794 
 

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14.4.2 
Primary Effectiveness Objective 
Primary Effectiveness Objective 
To demonstrate that the primary effectiveness rate associated with the Diamond-Temp ablation system 
is higher than the pre-specified Objective Performance Criterion (OPC). 
 
Hypothesis 
H0: P ≤ P0 
H1: P > P0 
where P0 = 40% (Effectiveness OPC), and higher effectiveness rates are better. 
 
Endpoint definition and derivation  
The primary effectiveness endpoint is defined as freedom from documented Atrial Fibrillation (AF), 
Atrial Flutter* (AFL) and Atrial Tachycardia (AT) 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: 
• 
Inability to electrically isolate all accessible targeted pulmonary veins during the ablation 
procedure. 
• 
Documented episodes of AF, AFL or AT lasting ≥30 seconds in duration as evidenced by 
electrocardiographic data during the effectiveness evaluation period. 
• 
DC cardioversion for AF, AFL or AT during the effectiveness evaluation period. 
• 
A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period. 
• 
Use of a new or previously failed anti-arrhythmic drug (AAD) at a dose greater than the highest 
ineffective dose for AF during the effectiveness evaluation period. 
• 
Use of a non-study device for ablation of any AF targets during the index or repeat ablation 
procedure during the blanking period. 
• 
More than one (1) repeat ablation procedure during the 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. 
 
Performance Requirements  
The null hypothesis will be rejected if the one-sided 97.5% lower confidence bound is greater than 40%. 
 
Rationale for Performance Criteria 
The performance goal was derived based on the minimum 12-month success rate for persistent AF 
recommended in the 2017 HRS Expert Consensus Statement on Catheter and Surgical Ablation of AF. 
 
Analysis Methods 
The primary effectiveness rate will be analyzed using the Kaplan-Meier method. The components of the 
effectiveness composite endpoint will also be summarized to show the number and percentage of 
subjects meeting each component. 
 

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Determination of Subjects/Data for Analysis  
The main analysis of the primary effectiveness objective will be based on the mITT population, which 
includes all subjects who sign informed consent, meet eligibility criteria and attempt study treatment 
(i.e. catheter inserted into vasculature). Additionally, sensitivity analysis for the primary effectiveness 
objective will be conducted on the Per-Protocol population, which includes all mITT subjects who do not 
have any major protocol violations (i.e., eligibility criteria violations, or ablation treatment with a non-
study catheter), and the ITT population, which includes all subjects who sign informed consent and 
attempt study treatment. 
 
14.5 Secondary Objective(s) 
The secondary objectives will further characterize the performance of the DiamondTemp Ablation 
System. All secondary endpoints will be analyzed using descriptive statistics. 
 
14.5.1 
Secondary Objective #1 
Objective 
To estimate the 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. 
 
Endpoint Definition and derivation 
The SAE composite endpoint is comprised of the same types of events as defined for the primary safety 
endpoint but occurring within 30 days post index ablation. 
 
Analysis Methods 
This secondary endpoint will be analyzed using the Kaplan-Meier method. The components of the SAE 
composite endpoint will also be summarized to show the number and percentage of subjects meeting 
each component. 
 
Determination of Subjects/Data for Analysis  
All subjects in the mITT population will be included in the analysis. 
 
14.5.2 
Secondary Objective #2 
Objective 
To estimate the freedom from documented AF/AFL/AT episodes during the effectiveness evaluation 
period lasting ≥30 seconds in duration by ECG monitoring. 
 
Endpoint Definition and derivation 
A subject is considered a failure for this endpoint if he/she has any documented AF/AFL/AT episode ≥
30 seconds by ECG monitoring during the effectiveness evaluation period. 
 
Analysis Methods 
This secondary endpoint will be analyzed using the Kaplan-Meier method. 
 
Determination of Subjects/Data for Analysis  
All subjects in the mITT population will be included in the analysis. 

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14.5.3 
Secondary Objective #3 
Objective 
To estimate the freedom from documented AF/AFL/AT episodes during the effectiveness evaluation 
period in the absence of class I and III anti-arrhythmic drug therapy. 
 
Endpoint Definition and derivation 
A subject is considered a failure for this endpoint if he/she has any documented AF/AFL/AT episode 
and/or uses any class I/III AAD during the effectiveness evaluation period. 
 
Analysis Methods 
This secondary endpoint will be analyzed using the Kaplan-Meier method. 
 
Determination of Subjects/Data for Analysis  
All subjects in the mITT population will be included in the analysis. 
 
14.5.4 
Secondary Objective #4 
Objective 
To estimate the rate of acute procedural success. 
 
Endpoint Definition and derivation 
An acute procedural success is defined as confirmation of electrical isolation of PVs at least 20 minutes 
following the last ablation around the respective PV. 
 
Analysis Methods 
This secondary endpoint will be analyzed using the Binomial method. 
 
Determination of Subjects/Data for Analysis 
All subjects in the mITT population will be included in the analysis. The analysis will be based on index 
ablation procedures only. 
 
14.5.5 
Secondary Objective #5 
Objective 
To estimate the rate of single procedure success with freedom from AF/AFL/AT recurrence. 
 
Endpoint Definition and derivation 
A subject is considered a single procedure success if he/she is treated with one single ablation 
procedure during study participation and free from documented AF/AFL/AT episode at 12 months post 
index ablation. 
 
Analysis Methods 
This secondary endpoint will be analyzed using the Kaplan-Meier method. 
 
Determination of Subjects/Data for Analysis 

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All subjects in the mITT population will be included in the analysis. 
 
14.5.6 
Secondary Objective #6 
Objective 
To estimate the rate of single procedure success with freedom from all primary effectiveness failure 
criteria. 
 
Endpoint Definition and derivation 
A subject is considered a single procedure success if he/she is treated with one single ablation 
procedure during study participation and free from all primary effectiveness failure criteria at 12 months 
post index ablation. 
 
Analysis Methods 
This secondary endpoint will be analyzed using the Kaplan-Meier method. 
 
Determination of Subjects/Data for Analysis 
All subjects in the mITT population will be included in the analysis. 
 
14.5.7 
Secondary Objective #7 
Objective 
To evaluate changes in QOL using the AFEQT Questionnaire. 
 
Endpoint Definition and derivation 
Subject’s QOL is measured using the AFEQT Questionnaire at baseline, 6-month visit and 12-month visit. 
The QOL change from baseline to 6 months, as well as change from baseline to 12 months will be 
calculated for each subject. 
 
Analysis Methods 
This secondary endpoint will be analyzed using descriptive statistics. 
 
Determination of Subjects/Data for Analysis 
All subjects in the mITT population will be included in the analysis. 
 
14.5.8 
Secondary Objective #8 
Objective 
To evaluate neurological changes measured using the NIH stroke scale. 
 
Endpoint Definition and derivation 
Subject’s neurological function is measured using the NIH stroke scale at baseline, pre-discharge visit 
and 12-month visit. The neurological change from baseline to pre-discharge, as well as change from 
baseline to 12 months will be calculated for each subject. 
 
Analysis Methods 
This secondary endpoint will be analyzed using descriptive statistics. 

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Determination of Subjects/Data for Analysis 
All subjects in the mITT population will be included in the analysis. 
 
14.6 Ancillary Objective(s) 
The ancillary endpoints will further characterize the performance of the DiamondTemp Ablation System. 
All ancillary endpoints will be analyzed using descriptive statistics. 
 
14.6.1 
Ancillary Objective #1 
Objective 
To characterize procedural characteristics. 
 
Endpoint Definition and derivation 
The following procedure characteristics will be summarized for all index ablation procedures: 
• 
Total procedure time (minutes), defined as time of investigational catheter insertion into the 
vasculature to time of last ablation catheter removal. 
• 
Total treatment device time (minutes), defined as time of delivery of first RF ablation with the 
investigational catheter to removal of the catheter. 
• 
Mean cumulative RF Time (minutes).     
• 
Mean duration of RF ablations (seconds). 
• 
Total fluid infused through the investigational catheter (mL). 
• 
Total fluoroscopy time (minutes). 
 
Analysis Methods 
This ancillary endpoint will be analyzed using descriptive statistics. 
 
Determination of Subjects/Data for Analysis 
All subjects in the mITT population will be included in the analysis. The analysis will be based on index 
ablation procedures only. 
 
14.6.2 
Ancillary Objective #2 
Objective 
To characterize the number of re-hospitalizations due to Atrial Fibrillation recurrence during the 
effectiveness evaluation period. 
 
Endpoint Definition and derivation 
The number of re-hospitalizations due to Atrial Fibrillation recurrence during the effectiveness 
evaluation period will be calculated for each subject. 
 
Analysis Methods 
This ancillary endpoint will be analyzed using descriptive statistics. 
 
Determination of Subjects/Data for Analysis 

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All subjects in the mITT population will be included in the analysis.  
 
14.7 Sample Size Determination 
For the primary safety objective, a sample size of 269 achieves 81% power to detect a difference of at 
least -4.5% against an OPC of 11.5% using a one-sided alpha level of 0.025. 
 
For the primary effectiveness objective, a sample size of 274 yields 86% power to detect a difference 
of 9% against an OPC of 40% using a one-sided alpha level of 0.025. 
 
Assuming a drop-out rate of 12%, as well as accounting for eligibility/screen failures, the enrollment goal 
of up to 376 subjects should be sufficient. 
 
14.8 Minimization of Bias 
Investigational site selection, subject selection, subject treatment, and evaluation of study data are 
potential sources of bias. Methods incorporated in the study design to minimize potential bias include 
(but are not limited to): 
• 
Subjects will undergo a rigorous screening to confirm eligibility for enrollment with defined 
inclusion/exclusion criteria prior to enrollment. 
• 
Demographics and medical history will be collected at baseline in order to later assess possible 
characteristics that may influence study endpoints. 
• 
Investigators and investigational sites will undergo site evaluation or qualification process based 
on pre-determined criteria prior to being invited to participate in the study. 
• 
All investigational site personnel and sponsor/delegate personnel will be trained on their 
respective aspects of the study using standardized training materials. 
• 
All study clinicians will be trained on and required to follow the Clinical Investigation Plan. 
• 
Monitoring visits will be conducted to verify case report forms (CRF) against source data and 
adherence to the Clinical Investigation Plan. 
• 
An independent Clinical Events Committee will be utilized to regularly review and adjudicate 
reported adverse events and deaths. 
• 
A Core Laboratory will be used to characterize atrial arrhythmia data obtained by Holter monitor 
and ECG. 
 
 Ethics 
 
15.1 Statement(s) of Compliance 
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as GCP. GCP includes review and approval by an independent EC before initiating a study, 
continuing review of an ongoing study by an EC, and obtaining and documenting the freely given 
informed consent of a subject before initiating the study. 
 
The DIAMOND- AF II study was designed to reflect the GCP principles outlined in ISO14155:2020 and 
other international clinical requirements outlined below. These include the protection of the rights, 
safety and well-being of human subjects, controls to ensure the scientific conduct and credibility of the 

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Clinical Investigation and the definition of responsibilities of the sponsor and Investigators. In 
accordance with ISO14155:2020, the sponsor shall avoid improper influence on, or inducement of, the 
subject, monitor, any Investigator(s) or other parties participating in, or contributing to, the Clinical 
Investigation. All Investigators shall avoid improper influence on or inducement of the subject, sponsor, 
monitor, other Investigator(s) or other parties participating in or contributing to the Clinical 
Investigation. AE and DD handling in the DIAMOND-AF II study is ISO14155:2020 compliant for all 
participating geographies. The study will comply with ISO 14155:2020 upon site activation on CIP version 
H, with noted exceptions outlined throughout the CIP and applicable study documents. 
 
The principles of the Declaration of Helsinki (DoH) have been implemented through the IC process, EC 
approval, study training, clinical trial registration, pre-clinical testing, risk-benefit assessment and 
publication policy.  
Ultimately, all study sites in all geographies will follow and comply with: 
• 
Principles of DoH 
• 
21 CFR Part 11 (Electronic Records, Electronic Signatures) 
• 
21 CFR Part 54 (Financial Disclosure by Clinical Investigators) 
• 
The CTA 
• 
The procedures described within this Clinical Investigational Plan 
• 
Local EC Requirements 
 
In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national and local laws, regulations, standards, and requirements of the countries/geographies 
where the study is being conducted. These include but are not limited to:  
• 
In the United States, the study will be conducted under an FDA IDE in compliance with 21 CFR 
Parts: 
o 50: Protection of Human Subjects 
o 54: Financial Disclosure by Clinical Investigators 
o 56: IRBs 
o 812: IDEs 
o ISO14155:2020 exception for US; all activation related requirements will be 
conducted/collected in separate parts with exception of a formal SIV/visit report 
• 
In Canada, SOR/98-282, Section 59-88 will be followed and Mandatory Problem Reporting 59(1), 
59(2), 60 (1). 
• 
In Europe the study will be conducted in compliance with the AIMDD 90/385/EEC or MDD 
93/42/EEC> EU MDR, and DoH version 2013. 
 
The study will be publicly registered prior to in accordance with the 2007 FDAAA and DoH on 
http://clinicaltrials.gov (PL 110-85, section 810(a)). In addition, the study may be registered in local 
regulatory databases where required by local law.  
 
Approval of the Clinical Investigational Plan (CIP) and CIP amendments is required from the following 
groups prior to any study procedures at a study site: 
• 
The Sponsor 
• 
Principal Investigators (where required by local law/regulations) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 

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• 
An independent medical EC or IRB. 
 
Similarly, approval of subsequent revisions to the CIP is required at each study site from the above 
mentioned groups prior to implementation of the revised CIP at the study site. 
 
 Study Administration 
 
16.1 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. 
 
16.1.1 
Study Monitor 
Study monitors assigned to the DIAMOND-AF II 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.   
 
 
16.1.2 
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 Clinical 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  source 
data per the Study Monitoring Plan 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 Clinical 
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. 
 

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If a deficiency is noted during the trial the monitor is required to bring this to the attention of the 
Sponsors’ Study 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.    
 
16.2 Data Management  
Data will be collected using an electronic data management system for studies.  CRF data will be stored 
in a secure, password-protected database which will be backed up. Data will be reviewed using 
programmed and manual data checks.  Study management reports may be generated to monitor data 
quality and study progress.  At the end of the study, the data will be frozen and will be retained 
indefinitely by the Sponsor. 
 
Procedures in the Clinical Investigational Plan (CIP) require source documentation. Source 
documentation will be maintained at the study site. Source documents, which may include but is not 
limited to, worksheets, subject medical records, and interrogation files, and must be created and 
maintained by the investigational study site team.  
 
Data management is performed by ARA Data Manager on an ongoing basis as data is entered by the Site 
and is marked as monitored. Since data will be entered and edited only by the Sites, no Self-Evident 
Corrections will be performed by ARA. If misspelled items are found during review, the Monitor for the 
Site will be notified. ARA will conduct ongoing review of query output and resolutions and provide 
feedback to the Sponsor as appropriate. During data review, ARA will discuss potential data issues with 
the Sponsor and/or a Monitor as needed to determine if data queries are warranted. Data queries 
entered by the Monitor are the responsibility of the Monitor to close or re-query as necessary. Those 
data queries entered by ARA Data Manager are generally the responsibility of ARA Data Manager to 
close or re-query as necessary; however, the Monitor can close an ARA Data Manager query when 
source data verification is required. If any query comments or responses require DM input, DM may also 
close those queries. Verification, validation and securing of electronic clinical data systems is the 
responsibility of the ARA Data Manager.  
 
The Principal Investigator for each Site will be asked to electronically sign the eCRFs for each subject 
after the subject completes the study and the subject’s data has been monitored, reviewed and 
reconciled, and there are no outstanding queries. Once signatures are complete, all forms will be locked, 
and all users will be changed to read-only, therefore removing the ability of the Site to change data and 
respond to queries. Once all the database lock activities are completed, the Sponsor will give approval to 
lock the database. The data reported on the eCRFs shall be derived from source documents and be 
consistent with these source documents, and any discrepancies shall be explained in writing.  
 

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The Investigator will clearly mark clinical records to indicate that the subject is enrolled in this Clinical 
Investigation. All records and other information about subjects participating in this study will be treated 
as confidential.  
 
Data is transferred and processed in compliance with HIPPA in the US and in compliance with the 
European privacy legislation, as required by the General Data Protection Regulation (GDPR). 
 
16.3 Direct Access to Source Data/Documents 
The Sponsor may conduct audits at participating study sites. The purpose of an audit is to verify the 
performance of the monitoring process and the study conduct, independently of the personnel directly 
involved in the study. RAs, such as the FDA, may also perform inspections at participating study sites. 
The Investigator and/or institution shall permit the Sponsor, IRB/ECs and RAs direct access to source 
data and documents during monitoring, audits and regulatory inspections. 
 
16.4 Confidentiality 
All information and data sent to parties involved in study conduct concerning subjects or their 
participation in this study will be considered confidential. Study sites will assign a unique SID to each 
subject. Records of the subject/SID relationship will be maintained by the study site. The SID number is 
to be recorded on all study documents to link them to the subject’s medical records at the study site.  
Confidentiality of data will be observed by all parties involved at all times throughout the Clinical 
Investigation. All data shall be secured against unauthorized access. The privacy of each subject and 
confidentiality of his/her information shall be preserved in reports and when publishing any data.  In the 
US, “Protected Health Information” (PHI) will be maintained in compliance with HIPAA. To maintain 
confidentiality, the subject’s name or any other PHI should not be recorded on any study document 
other than the Informed Consent Form. This scenario will be covered in the Informed Consent. In the 
event a subject’s name/PHI is included for any reason, it will be redacted as applicable. In the event of 
inability to redact the identification (e.g., digital media), it will be handled in a confidential manner by 
the authorized personnel.  Data relating to the study might be made available to third parties (for 
example in case of an audit performed by RA), provided the data are treated as confidential and that the 
subject’s privacy is guaranteed. No identifiable subject information will be published. 
 
16.5 Liability/Warranty/Insurance Information   
The Sponsor will provide proof and type of insurance coverage for subjects in the study, upon request or 
where required by local/country regulations. 
 
The Sponsor maintains appropriate clinical study liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage. If required, a clinical study insurance statement/certificate will be provided to the 
EC. 
 
16.5.1 
Insurance (Canada) 
Medtronic Canada ULC of Canada Ltd. is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate general liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 

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insurance coverage. If required, a General Liability insurance statement/certificate will be provided to 
the IRB/EC. 
 
16.5.2 
Insurance (Europe, Middle East, Africa) 
Medtronic Bakken Research Site B.V. is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical study liability insurance coverage as required 
under applicable laws and regulations and will comply with applicable local law and custom concerning 
specific insurance coverage. If required, a Clinical Trial insurance statement/certificate will be provided 
to the IRB/EC. 
 
16.6 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.   
 
16.7  CIP 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 Clinical Investigational Plan (CIP).  
Amendments to the Clinical Investigational Plan may be initiated by the Sponsor or at the request of an 
Investigator. A formal amendment cannot be initiated by an Investigator or clinical site staff without the 
approval of the Sponsor.   
 
Protocol amendments must be submitted and subsequently approved by the site IRB/EC and 
Geography-specific regulatory authorities (if regulatory approval is required). 
 
The Sponsor may make certain administrative changes to the protocol without prior approval of the 
IRB/EC. The Sponsor will notify all investigative sites of such changes to ensure the study continues to be 
conducted consistently across all sites. 
 
16.8 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. The 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. 
 
The Sponsor will retain the study records according to the Sponsor’s corporate policy and record 
retention schedule. The Sponsor’s records and reports will be maintained in a password-protected 
document management system, and paper documents (where applicable) will be stored in secured file 
cabinets during the course of this study. After closure of the study, the Sponsor will archive records and 
reports per the Sponsor’s standards and applicable regulations. 

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16.8.1 
Investigator Records 
The Investigator is responsible for the preparation and retention of the records cited below. All of the 
below records, with the exception of case history records and case report forms, should be kept in the 
Investigator Site File (i.e., the study binder provided to the Investigator) or Subject Study Binder. CRFs 
must be maintained and signed electronically within the electronic data capture system during the 
study. The following records are subject to inspection and must be retained for a period of two years (or 
longer as local law or hospital administration requires) after product approval or the date on which the 
investigation is terminated, or the date that the records are no longer required for purposes of 
supporting a pre-market approval application. 
• 
All correspondence between the IRB/EC, sponsor, monitor, Regulatory Agencies and the 
Investigator that pertains to the investigation, including required reports.  
• 
Subject’s case history records, including:  
o Signed and dated Informed Consent Form (In U.S. and Canada, signed by subject. In Europe, 
Middle East, Africa, signed by subject and Investigator).  
o Observations of AEs/ADEs/DDs 
o Medical history 
o Procedure and follow-up data  
o Documentation of the dates and rationale for any deviation from the protocol 
• 
Financial disclosure 
• 
Subject screening log& ID log. 
• 
Normal value(s)/range(s) for clinical laboratory test (if applicable). 
• 
Device Disposition Logs containing Model and serial numbers of devices delivered to the study 
site, subject IDs of the subjects with ablation, received dates of devices, used dates, , returned-
to-sponsor dates and reasons, initials of all persons who received, used or disposed each device, 
and method of disposal/destruction. 
• 
All approved versions of the CIP, IC, and IBs/Report of Prior Investigation Summary 
• 
Signed and dated Clinical Trial Agreement (CTA).  
• 
Curriculum Vitae (CV) of Principal Investigators and key members of investigation study site 
team (as required by applicable regulations. 
• 
Documentation of delegated tasks.  
• 
IRB/EC approval documentation. Written information that the Investigator or other study staff, 
when member of the IRB/EC, did not participate in the approval process. Approval 
documentation must include the IRB/ECs composition, where required per local law.   
• 
RA notification, correspondence and approval, where required per local law. 
• 
Study training records for study site staff.  
• 
Insurance certificates (Europe, Middle East, Africa, India, Australia, New Zealand, Greater China, 
Latin America and only).  
• 
Any other records that FDA and local regulatory agencies require to be maintained.  
• 
Final Study Report including the statistical analysis. 
 
16.8.2 
Subject Source Documents 
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, 

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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: 
1. Name and contact information. 
2. The study title (DIAMOND-AF II study), study number, and sponsor name (Medtronic/Epix 
Therapeutics). 
3. 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. 
4. The subject was allowed adequate time to consider participation prior to signing the consent 
form. 
5. A statement that written informed consent was obtained. 
6. Date of enrollment into the clinical study and the subject ID number. 
7. Date of procedure, procedural type, and device lot number. 
8. Visit dates. 
9. Cardiac medications. 
10. Occurrence of any adverse events. 
11. 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 type and location 
of source documents should be documented. The Investigator who signs Investigator Statement 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. 
 
 Reporting Requirements 
 
17.1 Investigator Reports 
The Investigator is responsible for the preparation (review and signature) and submission to the sponsor 
of all case report forms, adverse events and adverse device effects (reported per the country-specific 
collection requirements), device deficiencies, deaths, and any deviations from the Clinical Investigation 
Plan. If any action is taken by an IRB/EC with respect to this study, copies of all pertinent documentation 
must be forwarded to the Sponsor in a timely manner. Reports are subject to inspection and to the 
retention requirements as described above for Investigator records.  
 
Safety data Investigator reporting requirements are listed in Section 12.4.  The Investigator shall prepare 
and submit in a complete, accurate and timely manner the reports listed in this section. 
 
 
 
 

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 Publication and Use of Information 
The Sponsor is committed to the publication and dissemination of clinical study results, regardless of 
study outcomes.  Any publication or presentation relating to the DIAMOND-AF II Study will require that 
the Sponsor or financial supporter is included. A publication plan will be prepared to provide more 
details around the management of publications generated from this study. Registering and posting the 
study results on a publicly accessible database (e.g. ClinicalTrials.gov) will be based on the posting rules 
stipulated. 
 
18.1 Publication Committee 
The Sponsor may form a publication committee comprised of study Investigators. Sponsor personnel 
may serve as members of the committee. This committee will manage study publications with the goal 
of publishing findings from the data. The publication committee will develop the final publication plan as 
a separate document. 
 
 Suspension or Early Termination 
 
19.1 Premature Termination of the Study 
The Sponsor 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 these 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 the Sponsor to suspend or discontinue development of the device. 
 
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 the Sponsor. The 
IRB/EC and regulatory authorities, as applicable, will be notified. Detailed information on how enrolled 
subjects will be managed thereafter will be provided.  
 
19.2 Investigator/study site termination or suspension 
The Sponsor 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 the Sponsor 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 the Sponsor 
notifies the investigational center otherwise. 

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19.3 Investigator/EC Termination of Participation  
Any Investigator or IRB/ EC involved in the DIAMOND-AF II Study may discontinue participation in the 
study or withdrawal approval of the study, respectively, with suitable written notice to the Sponsor 
Investigators, associated IRBs/ECs, and regulatory authorities, as applicable. 
 
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 the Sponsor. The Investigator must return all documents and 
investigational product to the Sponsor, unless this action would jeopardize the rights, safety, or welfare 
of the subjects. 
 
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 the Sponsor. 
 
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