Status:
ACTIVE_NOT_RECRUITING
ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
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 Abl...
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.
Eligibility Criteria
Inclusion
- 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
- There are no exclusion criteria for this study.
Key Trial Info
Start Date :
October 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT06526546
Start Date
October 31 2024
End Date
February 1 2026
Last Update
December 29 2025
Active Locations (25)
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1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
2
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
3
Mills Peninsula Health Services
Burlingame, California, United States, 94010
4
Scripps Memorial Hospital
La Jolla, California, United States, 92037