Medtronic Terminate AF Study

Last updated: October 30, 2024
Sponsor: Medtronic Cardiac Surgery
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Atrial Fibrillation

Arrhythmia

Treatment

Surgical Ablation

Cardioblate and Cryoflex hand held devices

Clinical Study ID

NCT03546374
MDT17066ECT001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal AF.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of non-paroxysmal AF (persistent or longstanding persistent)

  • Concomitant indication for non-emergent open-heart surgery, eg,

  1. Coronary artery bypass grafting

  2. Valve repair or replacement

  • Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)

Exclusion

Exclusion Criteria:

  • Wolff-Parkinson-White syndrome

  • NYHA Class = IV

  • Left Ventricular Ejection Fraction ≤ 30%

  • Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery

  • Previous AF ablation, AV-nodal ablation, or surgical Maze procedure

  • Contraindication for anticoagulation therapy

  • Left atrial diameter > 6.0 cm

  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes

  • Renal failure requiring dialysis or hepatic failure

  • Life expectancy of less than 1 year

  • Predicted risk of operative mortality >10% as assessed by STS Risk Calculator

  • Pregnancy or desire to be pregnant within 12 months of the study treatment

  • Current diagnosis of active systemic infection

  • Active endocarditis

  • Documented MI 30 days prior to study enrollment

  • Current or planned participation in an investigational or observational drug ordevice trial related to the treatment of atrial arrhythmias

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Surgical Ablation
Phase:
Study Start date:
November 15, 2018
Estimated Completion Date:
December 31, 2026

Study Description

This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the US. The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months.

The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.

Connect with a study center

  • Stanford Hospitals and Clinic

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Adventist Health St. Helena

    Saint Helena, California 94574
    United States

    Active - Recruiting

  • Hartford Healthcare

    Hartford, Connecticut 06102
    United States

    Active - Recruiting

  • St Vincent Heart Center of Indiana

    Indianapolis, Indiana 46290
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Spectrum Health Hospitals

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • ProMedica Toledo

    Toledo, Ohio 43606
    United States

    Active - Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Lankenau Medical Center

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Completed

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Active - Recruiting

  • Virginia Mason Heart Institute

    Seattle, Washington 98101
    United States

    Active - Recruiting

  • St. Joseph Medical Center

    Tacoma, Washington 98405
    United States

    Site Not Available

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