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 2026-05-11
Summary
The main purpose of this study is to investigate the workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE catheter and TRUPULSE generator) when used for cardiac ablation with the new VARIPULSE Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days, often resolving within 24-48 hours, though sometimes lasting up to a week) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days 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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