Long-term safety and effectiveness of the VARIPULSE catheter system for treating atrial fibrillation
Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
NA · Biosense Webster, Inc. · NCT07227532
This will test whether the VARIPULSE pulsed‑field ablation catheter is safe and effective long‑term for people with symptomatic paroxysmal atrial fibrillation who need pulmonary vein isolation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Biosense Webster, Inc. (industry) |
| Locations | 12 sites (Phoenix, Arizona and 11 other locations) |
| Trial ID | NCT07227532 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic paroxysmal atrial fibrillation who are considered appropriate for catheter ablation and who are refractory to, intolerant of, or have contraindications to at least one Class I/III antiarrhythmic medication.
Not a fit: Patients with persistent or long‑standing persistent AF, prior surgical or catheter AF ablation, significant contraindicating medical problems, or life expectancy under 12 months are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide a durable, long‑term treatment option that reduces AF recurrence while maintaining a favorable safety profile for people with paroxysmal AF.
How similar studies have performed: Pulsed‑field ablation techniques, including the VARIPULSE system, have shown promising acute safety and pulmonary vein isolation results in prior studies and the device is FDA‑approved, but robust long‑term effectiveness data are still being gathered.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 11 other locations
- 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)
- Orlando Health Heart and Vascular Institute — Orlando, Florida, United States (RECRUITING)
- The Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States (RECRUITING)
- Trinity Health — Ypsilanti, Michigan, United States (RECRUITING)
- Albert Einstein College Of Medicine - Montefiore Medical Center — The Bronx, New York, United States (RECRUITING)
- Springfield Medical Center — Springfield, Ohio, United States (RECRUITING)
- Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States (RECRUITING)
- Winchester Medical Center — Winchester, Virginia, United States (RECRUITING)
- Mercy Hospital — Janesville, Wisconsin, United States (RECRUITING)
Study contacts
- Study coordinator: Emily Purcell
- Email: EPurcel1@its.jnj.com
- Phone: +1 949 230 3701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation