ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grandview Medical Center, Birmingham, Alabama, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Chronic success in ADVENT Trial treated subjects compared between treatment groups.

Time frame: 90 day-3 years
Occurrence of any of the following between the end of the Blanking Period (Day 90) in the ADVENT Trial through completion of follow-up in the ADVENT LTO study:

Detectable AF, AFL+, or AT
- ≥ 30 seconds in duration as adjudicated within the ADVENT Trial
- Investigator assessed ≥ 30 seconds in duration from any approved clinical recording devices considered standard of care* at the study center post-ADVENT Trial completion
- ≥ 30 seconds in duration recorded on the Holter monitor collected during the ADVENT Trial and the 3-4 Year Holter Monitor.
- ≥ 10-second of continuous AF, AFL or AT documented on any 12-lead ECG
Any Cardioversion for AF, AFL, or AT

Re-ablation for AF, AFL, or AT

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: ADVENT LTO

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 30, 2024
Registry last updated: Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed