A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
Overview
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).
Interventions
- Device Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.
Primary outcome measures
- Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure [Time frame: Within 7 days post index procedure]
- Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes [Time frame: Day 61-1095 post-index procedure]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 23 centers
- Phoenix Cardiovascular Research Group — Phoenix
- Tucson Medical Center Pima Heart and Vascular — Tucson
- OC Memorial — Fountain Valley
- San Diego Cardiac Center — San Diego
- Stanford Hospital and Clinics — Stanford
- Community Memorial Hospital — Ventura
- Aurora Denver Cardiology Associates — Aurora
- Colorado Heart and Vascular PC — Golden
- … and 15 more centers
Identifiers
NCT: NCT07227532 · BWI202405 · BWI202405