Long-term safety and effectiveness of the VARIPULSE catheter system for treating atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses the VARIPULSE pulsed‑field ablation catheter with the TRUPULSE generator to perform pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation. Participants are typically those who are candidates for catheter ablation and who are refractory to, intolerant of, or have contraindications to at least one Class I/III antiarrhythmic drug. The trial follows patients over the long term to document safety outcomes and durability of rhythm control after the procedure. Key exclusions include prior AF ablation, persistent or long‑standing persistent AF, significant contraindicating medical conditions, and limited life expectancy.

Why it matters

Who can join: the full rules

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

Where it's running

• Phoenix Cardiovascular Research Group
  Phoenix, Arizona, United States Recruiting
• Tucson Medical Center Pima Heart and Vascular
  Tucson, Arizona, United States Recruiting
• OC Memorial
  Fountain Valley, California, United States Recruiting
• Community Memorial Hospital
  Ventura, California, United States Recruiting
• Aurora Denver Cardiology Associates
  Aurora, Colorado, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Emily Purcell
• Email: EPurcel1@its.jnj.com
• Phone: +1 949 230 3701

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.