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

Biosense Webster, Inc. · NCT07227532

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
276
US sites recruiting
23
Study start
October 21, 2025
Record last updated
September 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Conditions: Atrial Fibrillation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Emily Purcell · +1 949 230 3701 · EPurcel1@its.jnj.com
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