RecruitingNot ApplicableNCT07227532

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

Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System

Sponsor

Biosense Webster, Inc.

Enrollment

276 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

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

Min Age: 22 Years

Inclusion Criteria4

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 Criteria6

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