Trial Outcomes & Findings for DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation (NCT NCT03334630)

Last Updated: 2025-02-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

482 participants

Primary outcome timeframe

Within 30-days or 6-months after index ablation procedure

Results posted on

2025-02-13

Participant Flow

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

Participant milestones

Participant milestones
Measure	DiamondTemp Ablation Catheter 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	TactiCath Quartz 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
Overall Study STARTED	239	243
Overall Study COMPLETED	225	230
Overall Study NOT COMPLETED	14	13

Reasons for withdrawal

Reasons for withdrawal
Measure	DiamondTemp Ablation Catheter 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	TactiCath Quartz 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
Overall Study Withdrawal by Subject	7	7
Overall Study Lost to Follow-up	3	1
Overall Study Adverse Event	0	1
Overall Study Physician Decision	1	1
Overall Study Enrollment closed	2	1
Overall Study Subject not treated with study ablation due to technical difficulties	0	1
Overall Study Subject unable to complete 12-month follow-up visit	1	1

Baseline Characteristics

DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DiamondTemp Ablation Catheter n=239 Participants 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	TactiCath Quartz Ablation Catheter n=243 Participants 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 n=482 Participants Total of all reporting groups
Age, Continuous	62.3 years STANDARD_DEVIATION 11.1 • n=5 Participants	63.0 years STANDARD_DEVIATION 10.4 • n=7 Participants	62.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	100 Participants n=7 Participants	203 Participants n=5 Participants
Sex: Female, Male Male	136 Participants n=5 Participants	143 Participants n=7 Participants	279 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	167 Participants n=5 Participants	169 Participants n=7 Participants	336 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	66 Participants n=5 Participants	69 Participants n=7 Participants	135 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	159 Participants n=5 Participants	161 Participants n=7 Participants	320 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	73 Participants n=5 Participants	74 Participants n=7 Participants	147 Participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants	111 participants n=7 Participants	220 participants n=5 Participants
Region of Enrollment Czechia	61 participants n=5 Participants	62 participants n=7 Participants	123 participants n=5 Participants
Region of Enrollment Italy	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment France	66 participants n=5 Participants	67 participants n=7 Participants	133 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30-days or 6-months after index ablation procedure

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

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=239 Participants 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	TactiCath Quartz Ablation Catheter n=243 Participants 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
Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs) Free from primary safety event	231 Participants	227 Participants
Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs) Not free from primary safety event	8 Participants	16 Participants

PRIMARY outcome

Timeframe: 3-12M (3-12 months) after index ablation procedure

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

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

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=239 Participants 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	TactiCath Quartz Ablation Catheter n=243 Participants 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
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). Free from primary effectiveness failure criteria	189 Participants	184 Participants
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). Not free from primary effectiveness failure criteria	50 Participants	59 Participants

SECONDARY outcome

Timeframe: Index ablation procedure

Population: Subjects with measure available.

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

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=235 Participants 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	TactiCath Quartz Ablation Catheter n=238 Participants 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
Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)	14.7 seconds Standard Deviation 5.3	32.6 seconds Standard Deviation 25.3

SECONDARY outcome

Timeframe: Index ablation procedure

Population: Subjects with measure available.

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

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=235 Participants 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	TactiCath Quartz Ablation Catheter n=238 Participants 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
Mean Cumulative RF Time Per Procedure (Minutes)	17.9 minutes Standard Deviation 8.1	29.8 minutes Standard Deviation 14.0

SECONDARY outcome

Timeframe: Within 7-days after the index ablation procedure

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

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

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=239 Participants 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	TactiCath Quartz Ablation Catheter n=243 Participants 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
Freedom From a Composite of SAE Occurring Within 7-days Free from composite SAEs within 7 days	231 Participants	230 Participants
Freedom From a Composite of SAE Occurring Within 7-days Not free from composite SAEs within 7 days	8 Participants	13 Participants

SECONDARY outcome

Timeframe: 3-12 months after index ablation procedure

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

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.

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=239 Participants 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	TactiCath Quartz Ablation Catheter n=243 Participants 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
Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs). Free from documented AF, AT and AFL episodes in the absence of class I and III AADs	142 Participants	120 Participants
Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs). Not free from documented AF, AT and AFL episodes in the absence of class I and III AADs	97 Participants	123 Participants

SECONDARY outcome

Timeframe: Index ablation procedure

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

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.

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=239 Participants 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	TactiCath Quartz Ablation Catheter n=243 Participants 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
Rate of Acute Procedural Success Acute procedural success	228 Participants	228 Participants
Rate of Acute Procedural Success Not acute procedural success	11 Participants	15 Participants

SECONDARY outcome

Timeframe: Index ablation procedure through 12-months after index ablation procedure

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

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.

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=239 Participants 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	TactiCath Quartz Ablation Catheter n=243 Participants 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
Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months. Single procedure success	183 Participants	185 Participants
Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months. Not single procedure success	56 Participants	58 Participants

SECONDARY outcome

Timeframe: Index ablation procedure through 12-months after index ablation procedure

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

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.

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=239 Participants 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	TactiCath Quartz Ablation Catheter n=243 Participants 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
Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria. Single procedure success	175 Participants	173 Participants
Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria. Not single procedure success	64 Participants	70 Participants

SECONDARY outcome

Timeframe: Index ablation procedure

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

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

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=239 Participants 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	TactiCath Quartz Ablation Catheter n=243 Participants 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
Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs) Occurrence of electrically reconnected PVs	45 Participants	45 Participants
Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs) No occurrence of electrically reconnected PVs	194 Participants	198 Participants

SECONDARY outcome

Timeframe: Baseline, 6-months after index ablation and 12-months after index ablation

Population: Subjects with measure available.

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.

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=215 Participants 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	TactiCath Quartz Ablation Catheter n=219 Participants 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
Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire Change from baseline to 6 months	27.8 score on a scale Standard Deviation 23.1	25.5 score on a scale Standard Deviation 22.7
Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire Change from baseline to 12 months	31.1 score on a scale Standard Deviation 23.4	30.1 score on a scale Standard Deviation 23.2

SECONDARY outcome

Timeframe: Baseline, pre-discharge after index ablation and 12-months after index ablation procedure

Population: Subjects with measure available.

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.

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=216 Participants 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	TactiCath Quartz Ablation Catheter n=222 Participants 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
Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS) Change from baseline to 12 months	-0.1 score on a scale Standard Deviation 0.36	-0.1 score on a scale Standard Deviation 0.38
Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS) Change from baseline to 6 months	0 score on a scale Standard Deviation 0.30	0 score on a scale Standard Deviation 0.32

SECONDARY outcome

Timeframe: Index ablation procedure

Population: Subjects with measure available.

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.

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=235 Participants 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	TactiCath Quartz Ablation Catheter n=240 Participants 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 Procedure Time (Minutes)	109.7 minutes Standard Deviation 46.2	115.4 minutes Standard Deviation 50.8

SECONDARY outcome

Timeframe: Index ablation procedure

Population: Subjects with measure available.

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.

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=235 Participants 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	TactiCath Quartz Ablation Catheter n=238 Participants 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
Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes)	65.7 minutes Standard Deviation 29.9	69.4 minutes Standard Deviation 35.2

SECONDARY outcome

Timeframe: Index ablation procedure

Population: Subjects with measure available.

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.

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=235 Participants 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	TactiCath Quartz Ablation Catheter n=239 Participants 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 Treatment Device Time (Minutes)	83.1 minutes Standard Deviation 34.0	91.4 minutes Standard Deviation 60.9

SECONDARY outcome

Timeframe: Index ablation procedure

Population: Subjects with measure available.

Total number of RF ablations per procedure at index procedure

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=232 Participants 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	TactiCath Quartz Ablation Catheter n=238 Participants 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 Number of RF Ablations Per Procedure	74.2 counts Standard Deviation 32.9	71.1 counts Standard Deviation 39.8

SECONDARY outcome

Timeframe: Index ablation procedure

Population: Subjects with measure available.

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

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=235 Participants 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	TactiCath Quartz Ablation Catheter n=237 Participants 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 Fluid Infused Through the Ablation Catheter (mL)	332.2 mL Standard Deviation 120.8	785.2 mL Standard Deviation 351.5

SECONDARY outcome

Timeframe: Index ablation procedure

Population: Subjects with measure available.

Total fluoroscopy time (minutes) at index procedure

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=232 Participants 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	TactiCath Quartz Ablation Catheter n=239 Participants 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 Fluoroscopy Time (Minutes)	12.7 minutes Standard Deviation 10.2	12.8 minutes Standard Deviation 9.4

SECONDARY outcome

Timeframe: 3-12 months after index ablation procedure

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

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

Outcome measures

Outcome measures
Measure	DiamondTemp Ablation Catheter n=239 Participants 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	TactiCath Quartz Ablation Catheter n=243 Participants 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
Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period 0 re-hospitalization	221 Participants	229 Participants
Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period 1 re-hospitalization	17 Participants	13 Participants
Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period 2 re-hospitalizations	1 Participants	1 Participants

Adverse Events

DiamondTemp Ablation Catheter

Serious events: 34 serious events

Other events: 32 other events

Deaths: 0 deaths

TactiCath Quartz Ablation Catheter

Serious events: 43 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Katie Flor, Principal Clinical Research Specialist

Medtronic

Phone: +1 763 526 9651

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	DiamondTemp Ablation Catheter n=239 participants at risk 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	TactiCath Quartz Ablation Catheter n=243 participants at risk 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
Cardiac disorders Atrial fibrillation	0.42% 1/239 • Number of events 1 • 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.	1.2% 3/243 • Number of events 3 • 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.
Cardiac disorders Atrial flutter	1.7% 4/239 • Number of events 4 • 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.	0.00% 0/243 • 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.
Cardiac disorders Pericardial effusion	0.84% 2/239 • Number of events 2 • 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.	1.2% 3/243 • Number of events 3 • 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.
Cardiac disorders Pericarditis	1.3% 3/239 • Number of events 3 • 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.	0.41% 1/243 • Number of events 1 • 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.
Cardiac disorders Sinus node dysfunction	0.00% 0/239 • 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.	1.2% 3/243 • Number of events 3 • 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.
Cardiac disorders Ventricular extrasystoles	0.42% 1/239 • Number of events 1 • 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.	1.6% 4/243 • Number of events 4 • 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.
General disorders Chest pain	1.3% 3/239 • Number of events 3 • 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.	1.2% 3/243 • Number of events 3 • 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.
Infections and infestations Urinary tract infection	0.42% 1/239 • Number of events 1 • 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.	1.6% 4/243 • Number of events 5 • 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.
Injury, poisoning and procedural complications Vascular access complication	0.42% 1/239 • Number of events 1 • 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.	1.2% 3/243 • Number of events 3 • 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.
Nervous system disorders Dizziness	2.5% 6/239 • Number of events 6 • 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.	1.2% 3/243 • Number of events 3 • 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.
Nervous system disorders Headache	1.7% 4/239 • Number of events 4 • 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.	1.2% 3/243 • Number of events 3 • 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.
Nervous system disorders Syncope	1.3% 3/239 • Number of events 3 • 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.	0.82% 2/243 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 4/239 • Number of events 4 • 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.	1.6% 4/243 • Number of events 4 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/239 • 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.	1.6% 4/243 • Number of events 4 • 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.
Vascular disorders Haematoma	0.42% 1/239 • Number of events 1 • 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.	2.5% 6/243 • Number of events 6 • 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.