A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
Recruiting · NCT07227532 · Interventional (participants receive a specific treatment) · Lead sponsor: Biosense Webster, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
What this trial 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).
Who can take part
Age range
22 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
22 locations listed across 13 US states.
- Phoenix Cardiovascular Research Group - Phoenix, Arizona, United States
- Tucson Medical Center Pima Heart and Vascular - Tucson, Arizona, United States
- OC Memorial - Fountain Valley, California, United States
- Community Memorial Hospital - Ventura, California, United States
- Aurora Denver Cardiology Associates - Aurora, Colorado, United States
- Mayo Clinic in Florida - Jacksonville, Florida, United States
- HCA Florida Mercy Hospital - Miami, Florida, United States
- Orlando Health Heart and Vascular Institute - Orlando, Florida, United States
- Edward Hospital Midwest Cardiovascular Institute - Naperville, Illinois, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- The Kansas City Heart Rhythm Institute - Overland Park, Kansas, United States
- Trinity Health - Ypsilanti, Michigan, United States
- Mayo Clinic Rochester - Rochester, Minnesota, United States
- Northwell Health Physician Partners Cardiology - Lake Success, New York, United States
- Albert Einstein College Of Medicine - Montefiore Medical Center - The Bronx, New York, United States
- The Christ Hospital - Cincinnati, Ohio, United States
- Springfield Medical Center - Springfield, Ohio, United States
- Texas Cardiac Arrhythmia Research Foundation - Austin, Texas, United States
- Baylor Scott and White Research Institute - Fort Worth, Texas, United States
- Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano - Plano, Texas, United States
- Winchester Medical Center - Winchester, Virginia, United States
- Mercy Hospital - Janesville, Wisconsin, United States