ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study
Purpose
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.
Condition
- Paroxysmal Atrial Fibrillation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- There are no exclusion criteria for this study.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Massachusetts General Hospital (MGH)
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
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.