BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Biosense Webster, Inc.
- Enrollment
- 276
- Locations
- 27
- Primary Endpoint
- Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure
Study Overview
Brief Summary
The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
- •Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
- •Willing and capable of providing consent
- •Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria
- •Previously diagnosed with persistent or long-standing persistent AF (more than [>] 7 days in duration)
- •Previous surgical or catheter ablation for AF
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
- •Current enrollment in an investigational study evaluating another device or drug
- •Life expectancy less than 12 months
- •Any contraindications as defined in the Protocol
Arms & Interventions
Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator.
Intervention: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator (Device)
Outcomes
Primary Outcomes
Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure
Time Frame: Within 7 days post index procedure
PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes
Time Frame: Day 61-1095 post-index procedure
Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation \[AF\], atrial tachycardia \[AT\] or atrial flutter \[AFL\] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.
Secondary Outcomes
No secondary outcomes reported