A Study to Predict Atrial Fibrillation (AF) Burden in Participants With PAF and PsAF Treated With the VARIPULSE™ PFA Catheter

Part of paid clinical trials in Austin, Texas.

Sponsor: Biosense Webster, Inc.
Study ID: NCT07788989
Status: Not Yet Recruiting

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Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: ALL
Age: 18 Years - 80 Years
Healthy Volunteers: Not accepted

Interventions

VARIPULSE Catheter System (PVI) — DEVICE
VARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure.
VARIPULSE Catheter System (PVI and PWI) — DEVICE
VARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure.

Study Details

The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and symptomatic persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts more than 7 days and doesn't stop on its own).

Key Dates

First listed: Aug 27, 2026
Start date: Oct 30, 2026
Status verified: Sep 2026
Primary completion: Oct 31, 2029
Completion: Oct 31, 2029

Study Design

Enrollment: 2,300 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Paroxysmal Atrial Fibrillation (PAF)
Participants with symptomatic paroxysmal atrial fibrillation (PAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) utilizing the VARIPULSE catheter as per the device Instructions for Use (IFU).
Experimental: Persistent Atrial Fibrillation (PsAF)
Participants with symptomatic persistent atrial fibrillation (PsAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) and posterior wall isolation (PWI) utilizing the VARIPULSE catheter as per the device IFU.