CONVERGE Post-Approval Study (PAS)

Last updated: April 29, 2025
Sponsor: AtriCure, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Arrhythmia

Dysrhythmia

Treatment

Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF

Clinical Study ID

NCT05393180
CP2021-1
  • Ages 18-80
  • All Genders

Study Summary

The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years and < 80 years at time of enrollment consent;

  2. Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography [TTE] withparasternal 4 chamber view or equivalent imaging modality;

  3. Refractory or intolerant to at least one AAD (class I and/or III);

  4. Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue)longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECASGuidelines (> 12 months of continuous AF);

  5. Life expectancy > 12 months; and

  6. Provides written informed consent.

Exclusion

Exclusion Criteria:

  1. Patients requiring concomitant surgery such as valvular repair or replacement,coronary artery bypass graft (CABG) surgery and atrial septal defect closure;

  2. Left ventricular ejection fraction < 35%;

  3. Pregnant or planning to become pregnant during study;

  4. Co-morbid medical conditions that limit one-year life expectancy;

  5. Previous cardiac surgery;

  6. History of pericarditis;

  7. Previous cerebrovascular accident (CVA), excluding fully resolved TIA;

  8. Patients who have active infection or sepsis

  9. Patients with esophageal ulcers strictures and varices;

  10. Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40);

  11. Patients who are contraindicated for anticoagulants such as heparin and coumadin;

  12. Patients who are being treated for ventricular arrhythmias;

  13. Patients who have had more than 2 prior left atrial catheter ablations for AF. NOTE:Note: Prior ablations should be limited to failed Pulmonary Vein Isolation (PVI) andno other left atrial lesions;

  14. Current participation in another clinical investigation of a medical device or adrug, or recent participation in such a study within 30 days prior to studyenrollment;

  15. Not competent to legally represent him or herself (e.g., requires a guardian orcaretaker as a legal representative);

  16. Patient has presence of thrombus in the left atrium determined by intraoperativeTEE;

  17. Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins >50 %stenosis;

  18. Planned Left Atrial Appendage Management (LAAM) with an endocardial implantabledevice during the course of the study;

  19. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results

  20. Presence of Barretts esophagitis

Study Design

Total Participants: 325
Treatment Group(s): 1
Primary Treatment: Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF
Phase:
Study Start date:
April 13, 2022
Estimated Completion Date:
December 31, 2028

Study Description

In accordance with FDA's Guidance on Balancing Premarket and Post Market Data Collection for Devices Subject to Premarket Approval AtriCure proposes to conduct a post-approval study following the Agency's PMA approval of the CONVERGE pivotal trial.

Currently there are no FDA-approved treatment options available for patients diagnosed with drug refractory, long-standing persistent AF, which is known to increase the risk of stroke by five-fold.

The CONVERGE trial was conducted to address the treatment need in patients with advanced forms of AF, using a hybrid epicardial plus endocardial ablation approach. The Hybrid Convergent procedure and the EPi-Sense device have evolved over the past decade and now has a robust history of clinical use in approximately 10,000 patients.

The totality of evidence generated from the CONVERGE trial and published literature provides reasonable assurance of the safety and effectiveness of the Hybrid Convergent procedure for the treatment of longstanding-persistent AF, which AtriCure believes will facilitate evidence-based decision-making between physicians and patients in addressing this disease for which there are no treatment options.

A post-approval study synopsis is proposed herein to bolster the results of the CONVERGE pre-market pivotal study. Specifically, the aim of this study is to:

  1. Further confirm the effectiveness of the EPi-sense device in a larger sample size by narrowing confidence intervals.

  2. Demonstrate the proposed standard of care patient guidelines and mitigations for inflammatory pericardial effusions further reduce the observed safety event rates.

  3. Demonstrate that the CONVERGE pre-market pivotal study results are generalizable across operators with varying levels of experience.

Collect and report on long term outcomes of the Hybrid Convergent procedure.

Connect with a study center

  • St Thomas

    London, Se1 7EH
    United Kingdom

    Active - Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92663
    United States

    Site Not Available

  • Sutter Bay Hospitals

    San Francisco, California 94107
    United States

    Active - Recruiting

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Active - Recruiting

  • Baycare Health Systems

    Clearwater, Florida 33759
    United States

    Active - Recruiting

  • Emory Saint Joseph Hopsital

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Ascension St. Vincent

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • MedStar Union Memorial Hospital

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • Southcoast Hospitals Group

    New Bedford, Massachusetts 02740
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Bon Secours

    Midlothian, Virginia 23114
    United States

    Active - Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Active - Recruiting

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