Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression (ADVENT LTO Study)

Details

This study is an observational, non-significant risk study. Subjects who participated in the FARAPULSE ADVENT Trial (NCT04612244) will be approached for participation.

Keywords

Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Pulsed Field Ablation, Cardiovascular Heart Diseases, Antiarrhythmic Anticoagulation, Cardiac monitor, Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • There are no exclusion criteria for this study.

Locations

  • UCSF
    San Francisco California 94143-0628 United States
  • Mills Peninsula Health Services
    Burlingame California 94010 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT06526546
Study Type
Observational
Participants
Expecting 583 study participants
Last Updated