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
Contact:
Grace Ha
GHA2@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Boston Scientific Corporation

Study Contact

Monika Bushko
+ 1 617 218 3963
monika.bushko@bsci.com

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.