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ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study

NCT ID: NCT06526546

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

356 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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

Conditions

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Paroxysmal Atrial Fibrillation

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vivek Reddy

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Grandview Medical Center

Birmingham, Alabama, United States

Site Status

Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Site Status

Mills Peninsula Health Services

Burlingame, California, United States

Site Status

Scripps Memorial Hospital

La Jolla, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

St. Lukes Idaho Cardiology Associates

Boise, Idaho, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Mount Sinai, Icahn School of Medicine

New York, New York, United States

Site Status

Northwell Health

New York, New York, United States

Site Status

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status

Doylestown Hospital

Doylestown, Pennsylvania, United States

Site Status

Presbyterian University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Pinnacle Health at Harrisburg Hospital

Wormleysburg, Pennsylvania, United States

Site Status

Trident Medical Center

Charleston, South Carolina, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

St. Thomas Research Institute, LLC

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Texas Cardiac Arrhythmia Research

Austin, Texas, United States

Site Status

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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PF116

Identifier Type: -

Identifier Source: org_study_id