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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT07227532

Run by

Biosense Webster, Inc.

People needed

276

Starts

2025-10-21

Expected to finish

2030-12-31

Last updated by the study team

2026-07-31

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mercy Hospital — Janesville, Wisconsin, United States (enrolling)
• Tucson Medical Center Pima Heart and Vascular — Tucson, Arizona, United States (enrolling)
• OC Memorial — Fountain Valley, California, United States (enrolling)
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States (enrolling)
• Baylor Scott and White Research Institute — Fort Worth, Texas, United States (enrolling)
• Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano — Plano, Texas, United States (enrolling)
• Winchester Medical Center — Winchester, Virginia, United States (enrolling)
• Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States (enrolling)
• Community Memorial Hospital — Ventura, California, United States (enrolling)
• Aurora Denver Cardiology Associates — Aurora, Colorado, United States (enrolling)
• HCA Florida Mercy Hospital — Miami, Florida, United States (enrolling)
• Orlando Health Heart and Vascular Institute — Orlando, Florida, United States (enrolling)
• The Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States (enrolling)
• Trinity Health — Ypsilanti, Michigan, United States (enrolling)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
• Albert Einstein College Of Medicine - Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Springfield Medical Center — Springfield, Ohio, United States (enrolling)
• San Diego Cardiac Center — San Diego, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Deaconess Gateway Hospital — Newburgh, Indiana, United States
• Norton Heart and Vascular Institute — Louisville, Kentucky, United States
• Colorado Heart and Vascular PC — Golden, Colorado, United States

Full record on ClinicalTrials.gov

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