Medtronic Terminate AF 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 atrial fibrillation (AF).

Eligibility

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 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

Conditions3

Locations15 sites

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