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NOT YET RECRUITING
NCT07788989
NA

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

Sponsor: Biosense Webster, Inc.

View on ClinicalTrials.gov

Summary

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).

Official title: High-Density Atrial Mapping After Pulsed Field Ablation (PFA): Development of an Algorithm to Predict Atrial Fibrillation (AF) Burden in Participants With Paroxysmal AF (PAF) and Persistent AF (PsAF) Treated With the VARIPULSE™ PFA Catheter

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

2300

Start Date

2026-10-30

Completion Date

2029-10-31

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

DEVICE

VARIPULSE Catheter System (PVI)

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.

DEVICE

VARIPULSE Catheter System (PVI and PWI)

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.

Locations (1)

Ascension Texas Cardiovascular

Austin, Texas, United States