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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorBiosense Webster, Inc.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Treatment groups

276 Participants
are divided into 1 treatment group

Sponsors and collaborators