A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

NCT07227532 · tracked via the Priya Life Science USA tracker

Sponsor

Biosense Webster, Inc.

Phase

Not applicable

Started

2025-10-21

Last updated

2026-08-31

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator: Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.

Study 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).

Eligibility

Sex

ALL

Min age

22 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF * Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD) * Willing and capable of providing consent * Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: * Previously diagnosed with persistent or long-standing persistent AF (more than \[\>\] 7 days in duration) * Previous surgical or catheter ablation for AF * Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF * Current enrollment in an investigational study evaluating another device or drug * Life expectancy less than 12 months * Any contraindications as defined in the Protocol

Primary outcome measure(s)

Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure — Within 7 days post index procedure
PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes — Day 61-1095 post-index procedure
Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation \[AF\], atrial tachycardia \[AT\] or atrial flutter \[AFL\] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.

Trial sites (22)

Facility	City	Region	Status
Phoenix Cardiovascular Research Group	Phoenix	Arizona	Recruiting
Tucson Medical Center Pima Heart and Vascular	Tucson	Arizona	Recruiting
OC Memorial	Fountain Valley	California	Recruiting
Community Memorial Hospital	Ventura	California	Recruiting
Aurora Denver Cardiology Associates	Aurora	Colorado	Recruiting
Mayo Clinic in Florida	Jacksonville	Florida	Recruiting
HCA Florida Mercy Hospital	Miami	Florida	Recruiting
Orlando Health Heart and Vascular Institute	Orlando	Florida	Recruiting
Edward Hospital Midwest Cardiovascular Institute	Naperville	Illinois	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	Recruiting
The Kansas City Heart Rhythm Institute	Overland Park	Kansas	Recruiting
Trinity Health	Ypsilanti	Michigan	Recruiting
Mayo Clinic Rochester	Rochester	Minnesota	Recruiting
Northwell Health Physician Partners Cardiology	Lake Success	New York	Recruiting
Albert Einstein College Of Medicine - Montefiore Medical Center	The Bronx	New York	Recruiting
The Christ Hospital	Cincinnati	Ohio	Recruiting
Springfield Medical Center	Springfield	Ohio	Recruiting
Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	Recruiting
Baylor Scott and White Research Institute	Fort Worth	Texas	Recruiting
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano	Plano	Texas	Recruiting
Winchester Medical Center	Winchester	Virginia	Recruiting
Mercy Hospital	Janesville	Wisconsin	Recruiting

More Biosense Webster, Inc. trials in the USA

An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation Active, not recruiting

A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation Recruiting

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

A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation Recruiting

A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) Active, not recruiting

Other trials for the same condition

SIMPLAAFY Clinical Trial Active, not recruiting

RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy. Active, not recruiting

Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA Recruiting

CardioFocus HeartLight Post-Approval Study Recruiting

CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07227532 on ClinicalTrials.gov ↗ ← All trials in the USA