ADVENT Post Approval Study

Last updated: April 22, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Arrhythmia

Treatment

FARAPULSE™ Pulsed Field Ablation System

Clinical Study ID

NCT06431815
PF304
  • Ages > 18
  • All Genders

Study Summary

The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System*; (Subjects refractory, or intolerant or contraindicated to at leastone class I or III antiarrhythmic medication or contraindicated to any class I orIII medications.)

  • Subjects who are willing and capable of providing informed consent;

  • Subjects who are willing and capable of participating in all testing and follow-upassociated with this clinical study at an approved clinical investigational site;

  • Subjects who are of legal age to give informed consent specific to the national law.

  • For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable CardiacMonitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICMinserted per the investigator's standard of care, up to 7 days after the ablationprocedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.

Exclusion

Exclusion Criteria:

  • Subjects with any known contraindication to an AF ablation or anticoagulation,including those listed in the Instructions For Use (IFU);

  • Subjects with any prior left atrium (LA) ablation;

  • Subjects who may need an ablation in the left atrium besides PVI, such as forleft-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrialtachycardia (AT) or atypical left-sided atrial flutter (AFL);

  • Women of childbearing potential who are or plan to become pregnant during the timeof the study (assessment per investigator's discretion);

  • Life expectancy of < 1 year, per investigator's medical judgement.

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: FARAPULSE™ Pulsed Field Ablation System
Phase:
Study Start date:
September 25, 2024
Estimated Completion Date:
October 31, 2029

Study Description

The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).

Connect with a study center

  • Sos Cardio Servicoshospitalares Ltda

    Florianópolis, Santa Catarina 88030-000
    Brazil

    Site Not Available

  • Instituto do Coração do HCFMUSP

    São Paulo, Sao Paulo 05403-900
    Brazil

    Site Not Available

  • Southlake Regional General Hospital

    Newmarket, Ontario L3Y8C3
    Canada

    Site Not Available

  • Institut de Cardiologie de Montreal-Hospital

    Montréal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Institut universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, Quebec G1V 4G5
    Canada

    Active - Recruiting

  • Hospital Regional de Concepcion

    Concepción, Biobio 4070022
    Chile

    Site Not Available

  • Mobile Infirmary Medical Center

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • Scottsdale Healthcare - Shea

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Alta Bates Summit Medical Center

    Oakland, California 94609
    United States

    Active - Recruiting

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Florida Heart Rhythm Specialists, PLLC

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • Baptist Medical Center

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Mount Sinai Medical Center

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Tallahassee Memorial Hospital

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

  • AdventHealth Tampa

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Active - Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4504
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • New York Hospital Queens

    Flushing, New York 11355
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10019
    United States

    Active - Recruiting

  • Northwell Health

    New York, New York 10075
    United States

    Active - Recruiting

  • East Carolina University Medical Center

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Hillcrest Medical Center

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Pinnacle Health at Harrisburg Hospital

    Harrisburg, Pennsylvania 17104
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Prisma Health Richland Hospital

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555-0737
    United States

    Active - Recruiting

  • Orion Medical

    Houston, Texas 77034
    United States

    Active - Recruiting

  • University of Texas Houston Health Science Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

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