A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
NCT07429214 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-07-13
Summary
The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSEâ„¢ Catheter and TRUPULSEâ„¢ Generator) when used for cardiac ablation with the new VARIPULSEâ„¢ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).
Conditions
Interventions
- DEVICE
-
Pulsed Field Ablation System
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE pro software 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
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-23
- Primary Completion
- 2026-12-30
- Completion
- 2026-12-30
- FDA Device
- Yes
Countries
- Belgium
- Denmark
- France
- Germany
- Italy
- Lithuania
- Netherlands
Study Locations
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