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

February 26, 2026 updated by: Boston Scientific Corporation

ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression (ADVENT LTO 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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Grandview Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center Phoenix
    • California
      • Burlingame, California, United States, 94010
        • Mills Peninsula Health Services
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital
      • San Francisco, California, United States, 94143-0628
        • University of California, San Francisco
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010-2975
        • Washington Hospital Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Idaho
      • Boise, Idaho, United States, 83702
        • St. Lukes Idaho Cardiology Associates
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital (MGH)
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital of Kansas City
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • New York
      • New York, New York, United States, 10075
        • Northwell Health
      • New York, New York, United States, 10029
        • Mount Sinai, Icahn School of Medicine
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Presbyterian University of Pennsylvania Medical Center
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health at Harrisburg Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29406
        • Trident Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Research Institute, LLC
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study eligibility criteria are defined below. Subjects who became deceased after completion of the ADVENT Trial will remain eligible for chart review data upon consent of a legally authorized representative (LAR). Subjects unable to complete the 7-day Holter monitor may consent to participate in the chart review portion only.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 day-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Vivek Reddy, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Actual)

December 8, 2025

Study Completion (Actual)

December 8, 2025

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PF116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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