ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study
- Conditions
- Paroxysmal Atrial Fibrillation
- Registration Number
- NCT06526546
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.
- Detailed Description
This study is an observational, non-significant risk study. Subjects who participated in the FARAPULSE ADVENT Trial (NCT04612244) will be approached for participation.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 583
- Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical investigation.
- Subjects who were enrolled, randomized and treated for paroxysmal atrial fibrillation, classified as Modified Intention-to-Treat subjects, and completed the 12-Month Follow-Up in the FARAPULSE ADVENT Trial (CIP CS0934; NCT04612244).
- Subjects or legally authorized representatives who are willing and capable of providing informed consent.
- Subjects who are willing to comply with the protocol requirements.
- There are no exclusion criteria for this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chronic success in ADVENT Trial treated subjects compared between treatment groups. 90 day-3 years Occurrence of any of the following between the end of the Blanking Period (Day 90) in the ADVENT Trial through completion of follow-up in the ADVENT LTO study:
Detectable AF, AFL+, or AT
* ≥ 30 seconds in duration as adjudicated within the ADVENT Trial
* Investigator assessed ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care\* at the study center post-ADVENT Trial completion
* ≥ 30 seconds in duration recorded on the Holter monitor collected during the ADVENT Trial and the 3-4 Year Holter Monitor.
* ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG
Any Cardioversion for AF, AFL, or AT
Re-ablation for AF, AFL, or AT
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Banner University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Mills Peninsula Health Services
🇺🇸Burlingame, California, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
St. Lukes Idaho Cardiology Associates
🇺🇸Boise, Idaho, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Scroll for more (16 remaining)Medical University of South Carolina🇺🇸Charleston, South Carolina, United States