Trial Outcomes & Findings for DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation (NCT NCT03643224)

Last Updated: 2025-10-23

Results Overview

Participant count of a composite of safety events including: serious adverse events (SAEs), procedure and/or device-related significant pericardial effusion, severe or clinically symptomatic pulmonary vein stenosis and atrioesophageal fistula

Recruitment status

COMPLETED

Study phase

Target enrollment

376 participants

Primary outcome timeframe

Ablation through 6 months

Results posted on

2025-10-23

Participant Flow

Recruitment for the study occurred from September 2018 to November 2023. The first subject was enrolled on September 19, 2018, and the last patient visit occurred on October 31, 2024.

Of the 376 subjects enrolled, 15 exited the study prior to undergoing ablation and were not included in the intent-to-treat (ITT) population. These subjects may have exited for various reasons including withdrawal of consent or clinical exclusion criteria discovered after enrollment. Baseline assessments were conducted prior to ablation to confirm eligibility and ensure protocol compliance.

Participant milestones

Participant milestones
Measure	Enrolled subjects All enrolled subjects underwent catheter ablation using the DiamondTemp™ Ablation (DTA) system. A total of 376 subjects were enrolled.
Overall Study STARTED	376
Overall Study Intention-to-treat (ITT)	361
Overall Study Modified intention-to-treat (MITT)	290
Overall Study COMPLETED	275
Overall Study NOT COMPLETED	101

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants All enrolled subjects underwent catheter ablation using the DiamondTemp™ Ablation (DTA) system. A total of 376 subjects were enrolled. Of these, 361 subjects underwent ablation and formed the intent-to-treat (ITT) population. Following ablation, subjects were followed for 12 months to assess safety and effectiveness outcomes. The mITT population (n=290) included subjects who met all eligibility criteria and were ablated. Subjects not meeting all eligibility criteria (n=71) were still followed as part of a secondary analysis. The follow-up protocol included scheduled assessments and monitoring at predetermined time points up to 12 months post-ablation. Exit reasons included voluntary withdrawal, death, or loss to follow-up.
Age, Continuous	66.0 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants
Sex: Female, Male Male	216 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	231 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	45 Participants n=5 Participants
Race/Ethnicity, Customized African	4 participants n=5 Participants
Race/Ethnicity, Customized Americas (Native North, South American, Canadian First)	5 participants n=5 Participants
Race/Ethnicity, Customized Caucasian (European descent)	228 participants n=5 Participants
Race/Ethnicity, Customized Unknown	48 participants n=5 Participants
Race/Ethnicity, Customized Other	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Ablation through 6 months

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
Primary Safety Events	16 participants

PRIMARY outcome

Timeframe: 12 months

The primary effectiveness endpoint is defined as freedom from documented AF, Atrial Flutter, (AFL) and Atrial Tachycardia (AT) episodes following the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
Primary Effectiveness	198 participants

SECONDARY outcome

Timeframe: Within 30-days post-index ablation

Freedom from a composite of SAEs occurring within 30-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
Freedom From a Composite of Serious Adverse Events (SAEs)	273 participants

SECONDARY outcome

Timeframe: Within 3 months

Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period lasting ≥ 30 seconds in duration by ECG monitoring.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
Freedom From Documented AF/AFL/AT Episodes	188 participants

SECONDARY outcome

Timeframe: Within 3 months

Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period in the absence of class I and III anti-arrhythmic drug therapy.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy.	126 participants

SECONDARY outcome

Timeframe: Day of index ablation procedure

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

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
Acute Procedural Success	289 participants

SECONDARY outcome

Timeframe: 12 months after the index ablation procedure

Participant count of single procedure success defined as the rate of subjects treated with one single ablation procedure for the entire enrollment period and with freedom from documented symptomatic AF, AT and AFL\* at 12 months.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
Single Procedure Success With Freedom From AF/AT/AFL	172 participants

SECONDARY outcome

Timeframe: 12 months

Participant count of single procedure success with freedom from all primary effectiveness failure criteria.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
Single Procedure Success With Freedom From All Primary Effectiveness Failures	155 participants

SECONDARY outcome

Timeframe: Day of index ablation procedure

QOL using the AFEQT Questionnaire, baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
AFEQT Quality of Life, Baseline	61.6 score on a scale Interval 59.1 to 64.1

SECONDARY outcome

Timeframe: 6 months after index ablation procedure

QOL using the AFEQT Questionnaire, 6 month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=270 Participants Subjects who met all eligibility criteria and were ablated.
AFEQT Quality of Life, 6-month Follow-up	85.6 score on a scale Interval 83.9 to 87.2

SECONDARY outcome

Timeframe: 12 months after index ablation procedure

QOL using the AFEQT Questionnaire, 12-month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=274 Participants Subjects who met all eligibility criteria and were ablated.
AFEQT Quality of Life, 12-month Follow up	88.0 score on a scale Interval 86.1 to 89.8

SECONDARY outcome

Timeframe: Index ablation procedure through 12 months

Changes in QOL using the AFEQT Questionnaire between 12-month and baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=274 Participants Subjects who met all eligibility criteria and were ablated.
Change in AFEQT Quality of Life From Baseline to 12-month	26.5 score on a scale Interval 23.8 to 29.2

SECONDARY outcome

Timeframe: Day of index ablation procedure

Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=286 Participants Subjects who met all eligibility criteria and were ablated.
National Institutes of Health Stroke Scale, Pre-discharge Improved -3 from baseline to pre-discharge	0 Participants
National Institutes of Health Stroke Scale, Pre-discharge Stayed the same +0 from baseline to pre-discharge	282 Participants
National Institutes of Health Stroke Scale, Pre-discharge Worsened +2 from baseline to pre-discharge	1 Participants
National Institutes of Health Stroke Scale, Pre-discharge Worsened +1 from baseline to pre-discharge	2 Participants
National Institutes of Health Stroke Scale, Pre-discharge Improved -2 from baseline to pre-discharge	0 Participants
National Institutes of Health Stroke Scale, Pre-discharge Improved -1 from baseline to pre-discharge	1 Participants

SECONDARY outcome

Timeframe: One month after index ablation procedure

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=198 Participants Subjects who met all eligibility criteria and were ablated.
National Institutes of Health Stroke Scale, One- Month Follow up Improved -3 from baseline to 1-month follow-up	0 Participants
National Institutes of Health Stroke Scale, One- Month Follow up Stayed the same +0 from baseline to 1-month follow-up	197 Participants
National Institutes of Health Stroke Scale, One- Month Follow up Worsened +1 from baseline to 1-month follow-up	0 Participants
National Institutes of Health Stroke Scale, One- Month Follow up Improved -1 from baseline to 1-month follow-up	1 Participants
National Institutes of Health Stroke Scale, One- Month Follow up Worsened +2 from baseline to 1-month follow-up	0 Participants
National Institutes of Health Stroke Scale, One- Month Follow up Improved -2 from baseline to 1-month follow-up	0 Participants

SECONDARY outcome

Timeframe: 12 months after the index ablation procedure

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=237 Participants Subjects who met all eligibility criteria and were ablated.
National Institutes of Health Stroke Scale, 12-month Follow-up Worsened +1 from baseline to 12-month follow-up	3 Participants
National Institutes of Health Stroke Scale, 12-month Follow-up Improved -3 from baseline to 12-month follow-up	1 Participants
National Institutes of Health Stroke Scale, 12-month Follow-up Worsened +2 from baseline to 12-month follow-up	1 Participants
National Institutes of Health Stroke Scale, 12-month Follow-up Stayed the same +0 from baseline to 12-month follow-up	228 Participants
National Institutes of Health Stroke Scale, 12-month Follow-up Improved -2 from baseline to 12-month follow-up	0 Participants
National Institutes of Health Stroke Scale, 12-month Follow-up Improved -1 from baseline to 12-month follow-up	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately after the index ablation procedure

Total procedure time (minutes), defined as time of investigational catheter insertion into the vasculature to time of last procedural ablation catheter removed.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=289 Participants Subjects who met all eligibility criteria and were ablated.
Total Procedure Time (Minutes)	104.0 minutes Standard Deviation 34.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of index ablation procedure

Total treatment device time (minutes), defined as time of delivery of first RF ablation with investigational catheter to removal of the investigational catheter.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=289 Participants Subjects who met all eligibility criteria and were ablated.
Total Treatment Device Time (Minutes)	85.8 minutes Standard Deviation 31.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of index ablation procedure

Mean cumulative RF Time (minutes).

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=288 Participants Subjects who met all eligibility criteria and were ablated.
Cumulative RF Time	47.6 minutes Standard Deviation 34.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of index ablation procedure

Mean duration of RF ablations (seconds)

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=279 Participants Subjects who met all eligibility criteria and were ablated.
Duration of RF Ablations (Seconds)	17.0 seconds Standard Deviation 22.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of index ablation procedure

Total fluid infused through the investigational catheter (mL)

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=281 Participants Subjects who met all eligibility criteria and were ablated.
Fluid Infused Through the Investigational Catheter (mL)	265.5 mL Standard Deviation 121.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of index ablation procedure

Total fluoroscopy exposure time (minutes)

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
Fluoroscopy Time (Minutes)	13.6 minutes Standard Deviation 17.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).

Number of subjects who were re-hospitalized due to atrial fibrillation recurrence after blanking period.

Outcome measures

Outcome measures
Measure	Modified Intention-to-treat (mITT) Cohort n=290 Participants Subjects who met all eligibility criteria and were ablated.
Incidence of Re-hospitalizations Due to Atrial Fibrillation Recurrence. 0 Re-hospitalizations	285 Participants
Incidence of Re-hospitalizations Due to Atrial Fibrillation Recurrence. 1 Re-hospitalization	5 Participants

Adverse Events

Intention-to-treat (ITT)

Serious events: 78 serious events

Other events: 22 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Intention-to-treat (ITT) n=361 participants at risk There were 376 subjects enrolled in the study. Of these, 361 (96.0%) underwent an ablation, while 15 exited without undergoing ablation.
Blood and lymphatic system disorders Anaemia	0.28% 1/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Blood and lymphatic system disorders Thrombocytopenia	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Angina pectoris	0.55% 2/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Angina unstable	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Atrial fibrillation	3.0% 11/361 • Number of events 12 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Atrial flutter	2.5% 9/361 • Number of events 9 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Atrial tachycardia	1.7% 6/361 • Number of events 6 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Cardiac failure	1.1% 4/361 • Number of events 4 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Cardiac failure acute	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Cardiac failure congestive	0.83% 3/361 • Number of events 3 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Cardiogenic shock	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Cardiovascular disorder	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Conduction disorder	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Myocardial infarction	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Pericardial effusion	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Pericarditis	0.55% 2/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Right ventricular failure	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Sinus arrest	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Sinus node dysfunction	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Tachycardia	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Cardiac disorders Ventricular extrasystoles	0.55% 2/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Eye disorders Visual impairment	0.55% 2/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Gastrointestinal disorders Colitis	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
General disorders Chest pain	1.7% 6/361 • Number of events 6 • From index ablation procedure through 12 months of follow-up.
General disorders Implant site extravasation	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
General disorders Oedema peripheral	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
General disorders Systemic inflammatory response syndrome	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Infections and infestations Bronchitis	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Infections and infestations Cellulitis	0.55% 2/361 • Number of events 3 • From index ablation procedure through 12 months of follow-up.
Infections and infestations Graft infection	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Infections and infestations Pneumonia	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Infections and infestations Post procedural pneumonia	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Infections and infestations Pulmonary sepsis	0.55% 2/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Infections and infestations Streptococcal infection	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Injury, poisoning and procedural complications Cardiac procedure complication	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Injury, poisoning and procedural complications Multiple injuries	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Injury, poisoning and procedural complications Post procedural stroke	1.1% 4/361 • Number of events 4 • From index ablation procedure through 12 months of follow-up.
Injury, poisoning and procedural complications Vascular access site pseudoaneurysm	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.55% 2/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Metabolism and nutrition disorders Fluid overload	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Musculoskeletal and connective tissue disorders Back pain	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Musculoskeletal and connective tissue disorders Exostosis	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Nervous system disorders Hypoaesthesia	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Nervous system disorders Ischaemic stroke	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Nervous system disorders Migraine with aura	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Nervous system disorders Syncope	0.55% 2/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Product Issues Device pacing issue	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Psychiatric disorders Depression	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Psychiatric disorders Hallucination, auditory	0.28% 1/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Renal and urinary disorders Acute kidney injury	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Renal and urinary disorders Haematuria	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Renal and urinary disorders Nephrolithiasis	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Renal and urinary disorders Renal colic	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.55% 2/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.55% 2/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.4% 5/361 • Number of events 5 • From index ablation procedure through 12 months of follow-up.
Surgical and medical procedures Haemorrhoid operation	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Vascular disorders Deep vein thrombosis	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Vascular disorders Haemorrhage	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Vascular disorders Hypertension	0.55% 2/361 • Number of events 2 • From index ablation procedure through 12 months of follow-up.
Vascular disorders Hypertensive crisis	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Vascular disorders Hypertensive urgency	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.
Vascular disorders Vasculitis	0.28% 1/361 • Number of events 1 • From index ablation procedure through 12 months of follow-up.

Other adverse events

Other adverse events
Measure	Intention-to-treat (ITT) n=361 participants at risk There were 376 subjects enrolled in the study. Of these, 361 (96.0%) underwent an ablation, while 15 exited without undergoing ablation.
Cardiac disorders Atrial Flutter	6.1% 22/361 • Number of events 24 • From index ablation procedure through 12 months of follow-up.

Additional Information

Josman Suri

Medtronic CAS

Phone: 7635050262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place