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Clinical Trials

Clinical Trial Number: Terminate AF
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Medtronic Terminate AF Study

Study ID: Terminate AF
Phase N/A
Physician Investigator(s)
Study Locations

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484.337.4363
[email protected]

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.

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Eligibility Criteria

Inclusion Criteria:

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

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 or device trial related to the treatment of atrial arrhythmias