Tests a catheter device for treating irregular heartbeat from atrial fibrillation
Studies long-term safety of the VARIPULSE catheter for paroxysmal atrial fibrillation in adults.
Plain-language title generated from the registry record
Registry title: A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
Key facts
- Where
- Aurora, Austin, Cincinnati, Detroit, Fort Worth, Fountain Valley, Iowa City, Jacksonville, Janesville, Kansas City, Lake Success, Miami, Naperville, Orlando, Overland Park, Phoenix, Plano, Rochester, Springfield, The Bronx, Trenton, Tucson, Ventura, Winchester, and Ypsilanti, United StatesSee the 25 sites
Where in United States
- Aurora Denver Cardiology AssociatesAurora, United StatesTaking people
- Texas Cardiac Arrhythmia Research FoundationAustin, United StatesTaking people
- The Christ HospitalCincinnati, United StatesTaking people
- Henry Ford Health SystemDetroit, United StatesTaking people
- Baylor Scott and White Research InstituteFort Worth, United StatesTaking people
- OC MemorialFountain Valley, United StatesTaking people
- University of Iowa Hospitals and ClinicsIowa City, United StatesTaking people
- Mayo Clinic in FloridaJacksonville, United StatesTaking people
- Mercy HospitalJanesville, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Northwell Health Physician Partners CardiologyLake Success, United StatesTaking people
- HCA Florida Mercy HospitalMiami, United StatesTaking people
- Edward Hospital Midwest Cardiovascular InstituteNaperville, United StatesTaking people
- Orlando Health Heart and Vascular InstituteOrlando, United StatesTaking people
- The Kansas City Heart Rhythm InstituteOverland Park, United StatesTaking people
- Phoenix Cardiovascular Research GroupPhoenix, United StatesTaking people
- Baylor Scott & White Research Institute at The Heart Hospital Baylor PlanoPlano, United StatesTaking people
- Mayo Clinic - RochesterRochester, United StatesTaking people
- Springfield Medical CenterSpringfield, United StatesTaking people
- Albert Einstein College of Medicine - Montefiore Medical CenterThe Bronx, United StatesTaking people
- Capital Health Regional Medical CenterTrenton, United StatesTaking people
- Tucson Medical Center Pima Heart and VascularTucson, United StatesTaking people
- Community Memorial HospitalVentura, United StatesTaking people
- Winchester Medical CenterWinchester, United StatesTaking people
- Trinity HealthYpsilanti, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biosense Webster, Inc.
- Trial code
- NCT07227532
- Record updated
- 4 November 2026
- Original description
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).Read full original descriptionShow less
BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
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).
Inclusion: 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: Previously diagnosed with persistent or long-standing persistent AF (more than [>] 7 days in duration); Previous surgical or catheter ablation for AF; Current enrollment in an investigational study evaluating another device or drug; Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF; Life expectancy less than 12 months; Any contraindications as defined in the Protocol.