A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
NCT07227532 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276
Last updated 2026-05-11
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).
Conditions
Interventions
- DEVICE
-
Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.
Sponsors & Collaborators
-
Biosense Webster, Inc.
lead INDUSTRY
Principal Investigators
-
Biosense Webster, Inc. Clinical Trial · Biosense Webster, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-21
- Primary Completion
- 2030-12-31
- Completion
- 2030-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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