DIAMOND-AF: DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03334630
• Collaborator: (none)
• Enrollment: 482
• Locations: 23
• Arms: 2
• Actual Duration (Months): 24.9
• Patients Per Site: 21
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.

Condition or Disease	Intervention/Treatment	Phase
Paroxysmal Atrial Fibrillation; Atrial Fibrillation	Device: DiamondTemp Ablation catheter; Device: TactiCath Quartz Ablation catheter	N/A

Detailed Description

The DIAMOND-AF study is a prospective, single blind, 1:1 randomized controlled study being performed at multiple centers in the United States, Canada and Europe. The study will evaluate the safety and effectiveness of the DiamondTemp System used for ablation in patients with paroxysmal atrial fibrillation (AF). Subjects will be randomized for treatment with either the DiamondTemp Ablation Catheter or the TactiCath™ Quartz Contact Force Ablation Catheter manufactured by Abbott. Patients will be followed for 12 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 482 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
• Actual Study Start Date: Nov 6, 2017
• Actual Primary Completion Date: Nov 18, 2019
• Actual Study Completion Date: Dec 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DiamondTemp Ablation Catheter Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter	Device: DiamondTemp Ablation catheter; a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Active Comparator: TactiCath Quartz Ablation Catheter Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter	Device: TactiCath Quartz Ablation catheter; a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Outcome Measures

Primary Outcome Measures

1. Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs) [Within 30-days or 6-months after index ablation procedure]

   The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis 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 Pericarditis Phrenic nerve paralysis Pulmonary edema Pulmonary vein stenosis Stroke post-ablation Thromboembolism Transient ischemic attack (TIA) post-ablation Vagal nerve injury Vascular access complications

2. Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation). [3-12M (3-12 months) after index ablation procedure]

   The primary 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 modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence 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

Secondary Outcome Measures

1. Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds) [Index ablation procedure]

   Mean duration of individual RF ablations (seconds) during the index ablation procedure

2. Mean Cumulative RF Time Per Procedure (Minutes) [Index ablation procedure]

   Mean cumulative RF time per procedure (minutes) during the index ablation procedure

3. Freedom From a Composite of SAE Occurring Within 7-days [Within 7-days after the index ablation procedure]

   Freedom from a composite of SAE occurring within 7-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device. The 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 Stroke post-ablation Thromboembolism Transient ischemic attack (TIA) post-ablation Vagal nerve injury Vascular access complications

4. Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs). [3-12 months after index ablation procedure]

   Freedom from documented AF, AT and AFL episodes following the blanking period through 12-month follow-up post-ablation procedure in the absence of class I and III anti-arrhythmic drug therapy.

5. Rate of Acute Procedural Success [Index ablation procedure]

   Rate of acute procedural success is defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV.

6. Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months. [Index ablation procedure through 12-months after index ablation procedure]

   Rate of single procedure success is 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.

7. Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria. [Index ablation procedure through 12-months after index ablation procedure]

   Rate of single procedure success is 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.

8. Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs) [Index ablation procedure]

   Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure.

9. Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire [Baseline, 6-months after index ablation and 12-months after index ablation]

   Accumulated changes in QOL using the AF QOL Survey (AFEQT Questionnaire) from baseline through 6 and 12 months following ablation procedure. The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire is an atrial fibrillation-specific health-related quality of life Questionnaire. The overall AFEQT score can range from 0 to 100, with 0 corresponding to complete disability and 100 corresponding to no disability. So a higher AFEQT score means a better outcome.

10. Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS) [Baseline, pre-discharge after index ablation and 12-months after index 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. The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The total NIHSS score can range from 0 to 42, with 0 indicating no stroke symptoms and 42 indicating extremely severe stroke symptoms. So a higher NIHSS score means a worse outcome.

11. Total Procedure Time (Minutes) [Index ablation procedure]

    Total procedure time (minutes) at index procedure is defined as time of first assigned ablation catheter insertion into the vasculature to time of last procedural ablation catheter removed.

12. Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes) [Index ablation procedure]

    Time to achieve initial PVI (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation catheter until confirmation of PVI.

13. Total Treatment Device Time (Minutes) [Index ablation procedure]

    Total treatment device time (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation treatment catheter to removal of the treatment catheter.

14. Total Number of RF Ablations Per Procedure [Index ablation procedure]

    Total number of RF ablations per procedure at index procedure

15. Total Fluid Infused Through the Ablation Catheter (mL) [Index ablation procedure]

    Total fluid infused through the assigned ablation catheter (mL) at index procedure

16. Total Fluoroscopy Time (Minutes) [Index ablation procedure]

    Total fluoroscopy time (minutes) at index procedure

17. Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period [3-12 months after index ablation procedure]

    Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

STUDY INCLUSION CRITERIA- Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF study:

1. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.

2. Subjects with a history of symptomatic, paroxysmal atrial fibrillation (PAF) who have had ≥2 episodes of PAF reported within the 6 months prior to index ablation procedure with a physician note indicating recurrent, self-terminating AF.

3. At least one episode of PAF documented by electrocardiographic data within the 12 months prior to index ablation procedure.

4. Refractory to at least one Class I-IV AAD for treatment of PAF.

5. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.

6. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.

7. Subject is willing and able to provide written consent.

STUDY EXCLUSION CRITERIA - Candidates will be excluded from the DIAMOND-AF study if any of the following conditions apply within the following timeframes:

At time of enrollment and/or prior to procedure:

1. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.

2. LA diameter > 5.5 cm.

3. LVEF < 35%.

4. Currently NYHA Class III or IV or exhibits uncontrolled heart failure.

5. BMI > 40 kg/m2.

6. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment.

7. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.

8. Coagulopathy, bleeding diathesis or suspected procoagulant state

9. Sepsis, active systemic infection or fever (>100.5°F / 38°C) within a week prior to the ablation procedure.

10. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.

11. Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.

12. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.

13. Positive pregnancy test results for female subjects of childbearing potential or breast feeding.

14. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.

15. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.

16. Life expectancy < 12 months based on medical history or the medical judgement of the investigator.

Within 1 month of enrollment or just prior to procedure:

1. Documented LA thrombus upon imaging.

2. Creatinine >2.5mg/dl or creatinine clearance <30mL/min.

Within 2 months of enrollment:

1. Regularly (uninterrupted) prescribed amiodarone.

Within 3 months of enrollment:

1. Significant GI bleed.

2. MI, unstable angina, cardiac surgery or coronary intervention.

Within 6 months of enrollment:

1. CABG procedure.

2. ICD, CRT leads or pacemaker implant procedure.

3. Documented stroke, CVA, TIA or suspected neurological event.

Within 12 months of enrollment:

1. An episode of AF lasting >7 days in duration.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grandview Medical Center	Birmingham	Alabama	United States	35242
2	University Of Alabama	Birmingham	Alabama	United States	35294
3	Keck School Of Medicine	Los Angeles	California	United States	90033
4	Sequoia Hospital	Redwood City	California	United States	94062
5	Florida Hospital Orlando	Orlando	Florida	United States	32803
6	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
7	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
8	Jackson Heart Clinic	Jackson	Mississippi	United States	39216
9	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
10	Montefiore Medical Center	New York	New York	United States	10467
11	Trident Medical Center	Charleston	South Carolina	United States	29406
12	Medical University Of South Carolina	Charleston	South Carolina	United States	29425
13	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	United States	78705
14	Houston Methodist Research Institute	Houston	Texas	United States	77030
15	Southlake Regional Medical Centre	Toronto	Newmarket/Ontario	Canada	L3Y 2P9
16	Na Homolce	Praha	Prague	Czechia	15000
17	St Anne's University Hospital	Brno		Czechia	65691
18	Institut Klinicke a Experimentalni Mediciny (IKEM)	Praha		Czechia	14021
19	Clinique Pasteur	Toulouse	Cedex 3	France	31076
20	Clinique du Tonkin	Villeurbanne	Lyon	France	69100
21	CHRU Nancy	Nancy		France	54511
22	Centro Cardiologico Monzino	Milan	Milano	Italy	20138
23	Ospedale dell'Angelo di Mestre	Mestre	Venezia	Italy	30174

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: Josef Kautzner, MD, PhD, Institut klinické a experimentální medicíny (IKEM)
• Principal Investigator: William Maddox, MD, University of Alabama at Birmingham
• Principal Investigator: Tom McElderry, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Statistical Analysis Plan - Apr 1, 2020
• Study Protocol: Revision I - Apr 1, 2020
• Study Protocol: Revision G - Feb 27, 2019
• Study Protocol: Revision F - Nov 15, 2018
• Study Protocol: Revision E - Apr 18, 2018
• Study Protocol: Revision D - Feb 20, 2018
• Study Protocol: Revision C - Aug 31, 2017
• Study Protocol: Revision H - Mar 18, 2019

More Information

Publications

• Iwasawa J, Koruth JS, Petru J, Dujka L, Kralovec S, Mzourkova K, Dukkipati SR, Neuzil P, Reddy VY. Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Aug 1;70(5):542-553. doi: 10.1016/j.jacc.2017.06.008.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT03334630
• Other Study ID Numbers: TP00599
• First Posted: Nov 7, 2017
• Last Update Posted: Feb 3, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: ablation; electrophysiology; atrial fibrillation; catheter; paroxysmal
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details	Enrollment/randomization occurred between 06NOV2017 and 26OCT2018 across 23 sites in the US, Canada and Europe.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using the DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat atrial fibrillation using the TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Period Title: Overall Study
STARTED	239	243
COMPLETED	225	230
NOT COMPLETED	14	13

Baseline Characteristics

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter	Total
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Total of all reporting groups
Overall Participants	239	243	482
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.3 (11.1)	63.0 (10.4)	62.7 (10.8)
Sex: Female, Male (Count of Participants)
Female	103 43.1%	100 41.2%	203 42.1%
Male	136 56.9%	143 58.8%	279 57.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 2.5%	5 2.1%	11 2.3%
Not Hispanic or Latino	167 69.9%	169 69.5%	336 69.7%
Unknown or Not Reported	66 27.6%	69 28.4%	135 28%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 1.3%	2 0.8%	5 1%
Asian	0 0%	2 0.8%	2 0.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 1.7%	4 1.6%	8 1.7%
White	159 66.5%	161 66.3%	320 66.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	73 30.5%	74 30.5%	147 30.5%
Region of Enrollment (participants) [Number]
Canada	1 0.4%	0 0%	1 0.2%
United States	109 45.6%	111 45.7%	220 45.6%
Czechia	61 25.5%	62 25.5%	123 25.5%
Italy	2 0.8%	3 1.2%	5 1%
France	66 27.6%	67 27.6%	133 27.6%

Outcome Measures

1. Primary Outcome

Title	Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)
Description	The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis 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 Pericarditis Phrenic nerve paralysis Pulmonary edema Pulmonary vein stenosis Stroke post-ablation Thromboembolism Transient ischemic attack (TIA) post-ablation Vagal nerve injury Vascular access complications
Time Frame	Within 30-days or 6-months after index ablation procedure

Outcome Measure Data

Analysis Population Description

Intention-to-treat population: all randomized subjects are included in this analysis.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	239	243
Free from primary safety event	231 96.7%	227 93.4%
Not free from primary safety event	8 3.3%	16 6.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DiamondTemp Ablation Catheter, TactiCath Quartz Ablation Catheter
	Comments	Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.
	Type of Statistical Test	Non-Inferiority
	Comments	Assuming a Control composite SAE freedom rate of 93.5%, 226 subjects per group yields 80% power to detect a non-inferiority margin of -6.5% between treatment groups at a significance level of 0.025.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The a priori threshold for statistical significance is 0.025.
	Method	Farrington-Manning non-inferiority test
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.0324
	Confidence Interval	(2-Sided) 95%; -0.0132 to 0.0779
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.24% = 0.0324

2. Primary Outcome

Title	Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation).
Description	The primary 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 modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence 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
Time Frame	3-12M (3-12 months) after index ablation procedure

Outcome Measure Data

Analysis Population Description

Intention-to-treat population: all randomized subjects are included in this analysis.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	239	243
Free from primary effectiveness failure criteria	189 79.1%	184 75.7%
Not free from primary effectiveness failure criteria	50 20.9%	59 24.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DiamondTemp Ablation Catheter, TactiCath Quartz Ablation Catheter
	Comments	Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.
	Type of Statistical Test	Non-Inferiority
	Comments	Assuming a Control primary effectiveness rate of 65%, 229 subjects per group yields 80% power to detect a non-inferiority margin of -12.5% between treatment groups at a significance level of 0.025.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The a priori threshold for statistical significance is 0.025.
	Method	Farrington-Manning non-inferiority test
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.034
	Confidence Interval	(2-Sided) 95%; -0.042 to 0.109
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.4% = 0.034

3. Secondary Outcome

Title	Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)
Description	Mean duration of individual RF ablations (seconds) during the index ablation procedure
Time Frame	Index ablation procedure

Outcome Measure Data

Analysis Population Description

Subjects with measure available.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	235	238
Mean (Standard Deviation) [seconds]	14.7 (5.3)	32.6 (25.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DiamondTemp Ablation Catheter, TactiCath Quartz Ablation Catheter
	Comments	Null hypothesis: the population means for the DiamondTemp and Control groups are not different. Alternative hypothesis: the population means for the DiamondTemp and Control groups are different.
	Type of Statistical Test	Superiority
	Comments	Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order: Mean duration of individual RF ablations (seconds) Mean cumulative RF time per procedure (minutes) Total fluoroscopy time (minutes) Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-17.9
	Confidence Interval	(2-Sided) 95%; -21.2 to -14.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is DiamondTemp minus Control. A lower value is better.

4. Secondary Outcome

Title	Mean Cumulative RF Time Per Procedure (Minutes)
Description	Mean cumulative RF time per procedure (minutes) during the index ablation procedure
Time Frame	Index ablation procedure

Outcome Measure Data

Analysis Population Description

Subjects with measure available.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	235	238
Mean (Standard Deviation) [minutes]	17.9 (8.1)	29.8 (14.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DiamondTemp Ablation Catheter, TactiCath Quartz Ablation Catheter
	Comments	Null hypothesis: the population means for the DiamondTemp and Control groups are not different. Alternative hypothesis: the population means for the DiamondTemp and Control groups are different.
	Type of Statistical Test	Superiority
	Comments	Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order: Mean duration of individual RF ablations (seconds) Mean cumulative RF time per procedure (minutes) Total fluoroscopy time (minutes) Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.9
	Confidence Interval	(2-Sided) 95%; -13.9 to -9.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is DiamondTemp minus Control. A lower value is better.

5. Secondary Outcome

Title	Freedom From a Composite of SAE Occurring Within 7-days
Description	Freedom from a composite of SAE occurring within 7-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device. The 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 Stroke post-ablation Thromboembolism Transient ischemic attack (TIA) post-ablation Vagal nerve injury Vascular access complications
Time Frame	Within 7-days after the index ablation procedure

Outcome Measure Data

Analysis Population Description

Intention-to-treat population: all randomized subjects are included in this analysis.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	239	243
Free from composite SAEs within 7 days	231 96.7%	230 94.7%
Not free from composite SAEs within 7 days	8 3.3%	13 5.3%

6. Secondary Outcome

Title	Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs).
Description	Freedom from documented AF, AT and AFL episodes following the blanking period through 12-month follow-up post-ablation procedure in the absence of class I and III anti-arrhythmic drug therapy.
Time Frame	3-12 months after index ablation procedure

Outcome Measure Data

Analysis Population Description

Intention-to-treat population: all randomized subjects are included in this analysis.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	239	243
Free from documented AF, AT and AFL episodes in the absence of class I and III AADs	142 59.4%	120 49.4%
Not free from documented AF, AT and AFL episodes in the absence of class I and III AADs	97 40.6%	123 50.6%

7. Secondary Outcome

Title	Rate of Acute Procedural Success
Description	Rate of acute procedural success is defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV.
Time Frame	Index ablation procedure

Outcome Measure Data

Analysis Population Description

Intention-to-treat population: all randomized subjects are included in this analysis.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	239	243
Acute procedural success	228 95.4%	228 93.8%
Not acute procedural success	11 4.6%	15 6.2%

8. Secondary Outcome

Title	Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months.
Description	Rate of single procedure success is 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.
Time Frame	Index ablation procedure through 12-months after index ablation procedure

Outcome Measure Data

Analysis Population Description

Intention-to-treat population: all randomized subjects are included in this analysis.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	239	243
Single procedure success	183 76.6%	185 76.1%
Not single procedure success	56 23.4%	58 23.9%

9. Secondary Outcome

Title	Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria.
Description	Rate of single procedure success is 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.
Time Frame	Index ablation procedure through 12-months after index ablation procedure

Outcome Measure Data

Analysis Population Description

Intention-to-treat population: all randomized subjects are included in this analysis.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	239	243
Single procedure success	175 73.2%	173 71.2%
Not single procedure success	64 26.8%	70 28.8%

10. Secondary Outcome

Title	Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs)
Description	Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure.
Time Frame	Index ablation procedure

Outcome Measure Data

Analysis Population Description

Intention-to-treat population: all randomized subjects are included in this analysis.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	239	243
Occurrence of electrically reconnected PVs	45 18.8%	45 18.5%
No occurrence of electrically reconnected PVs	194 81.2%	198 81.5%

11. Secondary Outcome

Title	Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire
Description	Accumulated changes in QOL using the AF QOL Survey (AFEQT Questionnaire) from baseline through 6 and 12 months following ablation procedure. The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire is an atrial fibrillation-specific health-related quality of life Questionnaire. The overall AFEQT score can range from 0 to 100, with 0 corresponding to complete disability and 100 corresponding to no disability. So a higher AFEQT score means a better outcome.
Time Frame	Baseline, 6-months after index ablation and 12-months after index ablation

Outcome Measure Data

Analysis Population Description

Subjects with measure available.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	215	219
Change from baseline to 6 months	27.8 (23.1)	25.5 (22.7)
Change from baseline to 12 months	31.1 (23.4)	30.1 (23.2)

12. Secondary Outcome

Title	Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS)
Description	Neurological changes measured using the NIH stroke scale between baseline and post-ablation (pre-discharge visit) and at 12 months post-ablation procedure. The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The total NIHSS score can range from 0 to 42, with 0 indicating no stroke symptoms and 42 indicating extremely severe stroke symptoms. So a higher NIHSS score means a worse outcome.
Time Frame	Baseline, pre-discharge after index ablation and 12-months after index ablation procedure

Outcome Measure Data

Analysis Population Description

Subjects with measure available.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	216	222
Change from baseline to 6 months	0 (0.30)	0 (0.32)
Change from baseline to 12 months	-0.1 (0.36)	-0.1 (0.38)

13. Secondary Outcome

Title	Total Procedure Time (Minutes)
Description	Total procedure time (minutes) at index procedure is defined as time of first assigned ablation catheter insertion into the vasculature to time of last procedural ablation catheter removed.
Time Frame	Index ablation procedure

Outcome Measure Data

Analysis Population Description

Subjects with measure available.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	235	240
Mean (Standard Deviation) [minutes]	109.7 (46.2)	115.4 (50.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DiamondTemp Ablation Catheter, TactiCath Quartz Ablation Catheter
	Comments	Null hypothesis: the population means for the DiamondTemp and Control groups are not different. Alternative hypothesis: the population means for the DiamondTemp and Control groups are different.
	Type of Statistical Test	Superiority
	Comments	Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order: Mean duration of individual RF ablations (seconds) Mean cumulative RF time per procedure (minutes) Total fluoroscopy time (minutes) Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.7
	Confidence Interval	(2-Sided) 95%; -14.4 to 3.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is DiamondTemp minus Control. A lower value is better.

14. Secondary Outcome

Title	Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes)
Description	Time to achieve initial PVI (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation catheter until confirmation of PVI.
Time Frame	Index ablation procedure

Outcome Measure Data

Analysis Population Description

Subjects with measure available.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	235	238
Mean (Standard Deviation) [minutes]	65.7 (29.9)	69.4 (35.2)

15. Secondary Outcome

Title	Total Treatment Device Time (Minutes)
Description	Total treatment device time (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation treatment catheter to removal of the treatment catheter.
Time Frame	Index ablation procedure

Outcome Measure Data

Analysis Population Description

Subjects with measure available.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	235	239
Mean (Standard Deviation) [minutes]	83.1 (34.0)	91.4 (60.9)

16. Secondary Outcome

Title	Total Number of RF Ablations Per Procedure
Description	Total number of RF ablations per procedure at index procedure
Time Frame	Index ablation procedure

Outcome Measure Data

Analysis Population Description

Subjects with measure available.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	232	238
Mean (Standard Deviation) [counts]	74.2 (32.9)	71.1 (39.8)

17. Secondary Outcome

Title	Total Fluid Infused Through the Ablation Catheter (mL)
Description	Total fluid infused through the assigned ablation catheter (mL) at index procedure
Time Frame	Index ablation procedure

Outcome Measure Data

Analysis Population Description

Subjects with measure available.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	235	237
Mean (Standard Deviation) [mL]	332.2 (120.8)	785.2 (351.5)

18. Secondary Outcome

Title	Total Fluoroscopy Time (Minutes)
Description	Total fluoroscopy time (minutes) at index procedure
Time Frame	Index ablation procedure

Outcome Measure Data

Analysis Population Description

Subjects with measure available.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	232	239
Mean (Standard Deviation) [minutes]	12.7 (10.2)	12.8 (9.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DiamondTemp Ablation Catheter, TactiCath Quartz Ablation Catheter
	Comments	Null hypothesis: the population means for the DiamondTemp and Control groups are not different. Alternative hypothesis: the population means for the DiamondTemp and Control groups are different.
	Type of Statistical Test	Superiority
	Comments	Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order: Mean duration of individual RF ablations (seconds) Mean cumulative RF time per procedure (minutes) Total fluoroscopy time (minutes) Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant.
Statistical Test of Hypothesis	p-Value	0.8528
	Comments	The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -1.9 to 1.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is DiamondTemp minus Control. A lower value is better.

19. Secondary Outcome

Title	Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period
Description	Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period
Time Frame	3-12 months after index ablation procedure

Outcome Measure Data

Analysis Population Description

Intention-to-treat population: all randomized subjects are included in this analysis.

Arm/Group Title	DiamondTemp Ablation Catheter	TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Measure Participants	239	243
0 re-hospitalization	221 92.5%	229 94.2%
1 re-hospitalization	17 7.1%	13 5.3%
2 re-hospitalizations	1 0.4%	1 0.4%

Adverse Events

Time Frame	All adverse events (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, were recorded on an AE case report form, from the time of signed informed consent through the twelve-month follow-up visit.
Arm/Group Title	DiamondTemp Ablation Catheter		TactiCath Quartz Ablation Catheter
Arm/Group Description	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter		Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
All Cause Mortality
	DiamondTemp Ablation Catheter		TactiCath Quartz Ablation Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/239 (0%)		0/243 (0%)
Serious Adverse Events
	DiamondTemp Ablation Catheter		TactiCath Quartz Ablation Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/239 (14.2%)		43/243 (17.7%)
Blood and lymphatic system disorders
Anaemia	1/239 (0.4%)	1	2/243 (0.8%)	2
Blood loss anaemia	0/239 (0%)	0	1/243 (0.4%)	1
Cardiac disorders
Arrhythmia supraventricular	1/239 (0.4%)	1	0/243 (0%)	0
Atrial fibrillation	10/239 (4.2%)	14	3/243 (1.2%)	3
Atrial flutter	2/239 (0.8%)	2	6/243 (2.5%)	6
Atrial tachycardia	1/239 (0.4%)	1	1/243 (0.4%)	1
Atrioventricular block complete	1/239 (0.4%)	1	0/243 (0%)	0
Cardiac perforation	1/239 (0.4%)	1	1/243 (0.4%)	1
Cardiac tamponade	1/239 (0.4%)	1	1/243 (0.4%)	1
Ischaemic cardiomyopathy	0/239 (0%)	0	1/243 (0.4%)	1
Pericardial effusion	0/239 (0%)	0	1/243 (0.4%)	1
Pericardial haemorrhage	0/239 (0%)	0	1/243 (0.4%)	1
Sinus node dysfunction	0/239 (0%)	0	1/243 (0.4%)	1
Supraventricular tachycardia	0/239 (0%)	0	2/243 (0.8%)	2
Gastrointestinal disorders
Abdominal pain	0/239 (0%)	0	1/243 (0.4%)	1
Abdominal pain upper	0/239 (0%)	0	1/243 (0.4%)	1
Dyspepsia	1/239 (0.4%)	1	0/243 (0%)	0
Nausea	0/239 (0%)	0	1/243 (0.4%)	1
Small intestinal obstruction	1/239 (0.4%)	1	1/243 (0.4%)	1
General disorders
Chest discomfort	1/239 (0.4%)	1	0/243 (0%)	0
Chest pain	2/239 (0.8%)	2	2/243 (0.8%)	2
Pyrexia	0/239 (0%)	0	1/243 (0.4%)	1
Hepatobiliary disorders
Cholelithiasis	1/239 (0.4%)	1	0/243 (0%)	0
Hepatic cirrhosis	1/239 (0.4%)	1	0/243 (0%)	0
Immune system disorders
Allergy to arthropod sting	0/239 (0%)	0	1/243 (0.4%)	1
Infections and infestations
Appendicitis	1/239 (0.4%)	1	0/243 (0%)	0
Colonic abscess	1/239 (0.4%)	1	0/243 (0%)	0
Diverticulitis	1/239 (0.4%)	1	0/243 (0%)	0
Influenza	1/239 (0.4%)	1	0/243 (0%)	0
Pneumonia	1/239 (0.4%)	1	0/243 (0%)	0
Respiratory tract infection	1/239 (0.4%)	1	0/243 (0%)	0
Wound infection staphylococcal	0/239 (0%)	0	1/243 (0.4%)	1
Injury, poisoning and procedural complications
Cranial nerve injury	1/239 (0.4%)	1	0/243 (0%)	0
Foot fracture	0/239 (0%)	0	1/243 (0.4%)	1
Postoperative hypotension	0/239 (0%)	0	1/243 (0.4%)	1
Vascular access complication	3/239 (1.3%)	3	5/243 (2.1%)	5
Venous injury	0/239 (0%)	0	1/243 (0.4%)	1
Metabolism and nutrition disorders
Haemochromatosis	0/239 (0%)	0	1/243 (0.4%)	1
Musculoskeletal and connective tissue disorders
Arthritis	0/239 (0%)	0	1/243 (0.4%)	1
Osteoarthritis	0/239 (0%)	0	1/243 (0.4%)	2
Spinal osteoarthritis	0/239 (0%)	0	1/243 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma	0/239 (0%)	0	1/243 (0.4%)	1
Uterine cancer	1/239 (0.4%)	1	0/243 (0%)	0
Nervous system disorders
Cerebrovascular accident	1/239 (0.4%)	1	1/243 (0.4%)	1
Dizziness	0/239 (0%)	0	1/243 (0.4%)	1
Dizziness postural	1/239 (0.4%)	1	0/243 (0%)	0
IVth nerve paralysis	0/239 (0%)	0	1/243 (0.4%)	1
Phrenic nerve paralysis	1/239 (0.4%)	1	0/243 (0%)	0
Presyncope	0/239 (0%)	0	1/243 (0.4%)	1
Sciatica	1/239 (0.4%)	1	0/243 (0%)	0
Seizure like phenomena	0/239 (0%)	0	1/243 (0.4%)	1
Transient ischaemic attack	3/239 (1.3%)	3	1/243 (0.4%)	1
Product Issues
Device pacing issue	0/239 (0%)	0	1/243 (0.4%)	1
Renal and urinary disorders
Renal disorder	0/239 (0%)	0	1/243 (0.4%)	1
Renal failure	0/239 (0%)	0	1/243 (0.4%)	1
Urinary retention	0/239 (0%)	0	1/243 (0.4%)	1
Reproductive system and breast disorders
Prostatitis	0/239 (0%)	0	1/243 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	2/239 (0.8%)	2	0/243 (0%)	0
Haemoptysis	0/239 (0%)	0	1/243 (0.4%)	1
Pneumothorax	0/239 (0%)	0	1/243 (0.4%)	1
Pulmonary oedema	0/239 (0%)	0	1/243 (0.4%)	1
Surgical and medical procedures
Angioplasty	0/239 (0%)	0	1/243 (0.4%)	1
Arthrodesis	1/239 (0.4%)	1	0/243 (0%)	0
Colostomy	1/239 (0.4%)	1	0/243 (0%)	0
Knee arthroplasty	1/239 (0.4%)	1	0/243 (0%)	0
Knee operation	0/239 (0%)	0	1/243 (0.4%)	1
Vascular disorders
Haemorrhage	0/239 (0%)	0	1/243 (0.4%)	1
Hypertension	1/239 (0.4%)	1	0/243 (0%)	0
Other (Not Including Serious) Adverse Events
	DiamondTemp Ablation Catheter		TactiCath Quartz Ablation Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/239 (13.4%)		41/243 (16.9%)
Cardiac disorders
Atrial fibrillation	1/239 (0.4%)	1	3/243 (1.2%)	3
Atrial flutter	4/239 (1.7%)	4	0/243 (0%)	0
Pericardial effusion	2/239 (0.8%)	2	3/243 (1.2%)	3
Pericarditis	3/239 (1.3%)	3	1/243 (0.4%)	1
Sinus node dysfunction	0/239 (0%)	0	3/243 (1.2%)	3
Ventricular extrasystoles	1/239 (0.4%)	1	4/243 (1.6%)	4
General disorders
Chest pain	3/239 (1.3%)	3	3/243 (1.2%)	3
Infections and infestations
Urinary tract infection	1/239 (0.4%)	1	4/243 (1.6%)	5
Injury, poisoning and procedural complications
Vascular access complication	1/239 (0.4%)	1	3/243 (1.2%)	3
Nervous system disorders
Dizziness	6/239 (2.5%)	6	3/243 (1.2%)	3
Headache	4/239 (1.7%)	4	3/243 (1.2%)	3
Syncope	3/239 (1.3%)	3	2/243 (0.8%)	2
Respiratory, thoracic and mediastinal disorders
Dyspnoea	4/239 (1.7%)	4	4/243 (1.6%)	4
Oropharyngeal pain	0/239 (0%)	0	4/243 (1.6%)	4
Vascular disorders
Haematoma	1/239 (0.4%)	1	6/243 (2.5%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

While the language in each agreement may vary slightly, in general it states that the Principal Investigator (PI) agrees to not independently discuss/publish trial results until a multi-center publication is released. If the multi-center publication is not submitted within one year after study completion across all centers, PIs may publish the results pertaining to their activities. PI must submit this request to the Sponsor for review/comment at least forty-five (45) days prior to submission.