ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study
ADVENT LTO
1 other identifier
observational
364
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 30, 2024
CompletedStudy Start
First participant enrolled
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2025
CompletedMarch 2, 2026
February 1, 2026
1.1 years
July 25, 2024
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chronic success in ADVENT Trial treated subjects compared between treatment groups.
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
Eligibility Criteria
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.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Grandview Medical Center
Birmingham, Alabama, 35243, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
Mills Peninsula Health Services
Burlingame, California, 94010, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
University of California, San Francisco
San Francisco, California, 94143-0628, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010-2975, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
St. Lukes Idaho Cardiology Associates
Boise, Idaho, 83702, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Mount Sinai, Icahn School of Medicine
New York, New York, 10029, United States
Northwell Health
New York, New York, 10075, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
Presbyterian University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Pinnacle Health at Harrisburg Hospital
Wormleysburg, Pennsylvania, 17043, United States
Trident Medical Center
Charleston, South Carolina, 29406, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
St. Thomas Research Institute, LLC
Nashville, Tennessee, 37205, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705, United States
Virginia Commonwealth University Health System
Richmond, Virginia, 23219, United States
Related Publications (1)
Reddy VY, Gerstenfeld EP, Mountantonakis SE, Patel C, Ellenbogen KA, Harding JD, Gibson DN, Natale A, Waks JW, Calkins H, Gupta SK, Woods CE, Whang W, Daccarett M, Cuoco FA, Delurgio DB, Richards E, Martens MD, Sutton B, Mansour M; ADVENT-LTO Study Investigators. Pulsed field ablation versus conventional thermal ablation for paroxysmal atrial fibrillation: 4-year outcomes in the ADVENT-LTO study. Nat Med. 2026 Feb 6. doi: 10.1038/s41591-026-04246-4. Online ahead of print.
PMID: 41652117DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vivek Reddy
MOUNT SINAI HOSPITAL
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2024
First Posted
July 30, 2024
Study Start
October 31, 2024
Primary Completion
December 8, 2025
Study Completion
December 8, 2025
Last Updated
March 2, 2026
Record last verified: 2026-02