ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study

ID#: NCT06526546

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Enrolling by invitation

Start Date: October 31, 2024

End Date: October 01, 2025

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.
Eligibility:

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.