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Medtronic Terminate AF Study

Medtronic Cardiac Surgery · NCT03546374

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
160
US sites recruiting
7
Study start
November 15, 2018
Record last updated
May 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 atrial fibrillation (AF).

Being studied: Surgical Ablation; Cardioblate and Cryoflex hand held devices

Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • History of non-paroxysmal AF (persistent or longstanding persistent)
  • Concomitant indication for non-emergent open-heart surgery, eg,
  • Coronary artery bypass grafting
  • Valve repair or replacement
  • Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)

Exclusion Criteria

  • Wolff-Parkinson-White syndrome
  • New York Heart Association (NYHA) Class = IV
  • Left Ventricular Ejection Fraction ≤ 30%
  • Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
  • Previous AF ablation, atrioventricular (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 or device trial related to the treatment of atrial arrhythmias

Recruiting US locations

  • St Vincent Heart Center of Indiana

    Indianapolis, IN 46290

    Site contact: David Heimansohn, MD · heimansohn@mac.com

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Serguei Melnitchouk, MD · smelnitchouk@mgh.harvard.edu

  • Corewell Health

    Grand Rapids, MI 49503

    Site contact: Edward Murphy, MD · edward.murphy@spectrumhealth.org

  • Washington University School of Medicine

    St Louis, MO 63110

    Site contact: Ralph J Damiano, MD · damianor@wustl.edu

  • Allegheny General Hospital

    Pittsburgh, PA 15212

    Site contact: Stephen Bailey, MD · stephen.bailey@ahn.org

  • Virginia Mason Heart Institute

    Seattle, WA 98101

    Site contact: Robert Moraca, MD · Bob.Moraca@Virginiamason.org

  • Swedish Medical Center

    Seattle, WA 98122

    Site contact: Eric Lehr, MD · Eric.Lehr@swedish.org

Study contacts (from the official record)

  • Stephanie Yong · 763-526-2032 · stephanie.yong@medtronic.com
  • Jessica Halverson · 763-514-9765 · Jessica.halverson@medtronic.com
All heart & blood pressure studies in Indiana →
Medtronic Terminate AF Study (NCT03546374) | Bored Studies