Health Trials

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Surgical Ablation
  • Cardioblate and Cryoflex hand held devices

Treatment groups

160 Participants
are divided into 1 treatment group

Locations

15
California
Stanford Hospitals and Clinic94304, Palo Alto United States
Adventist Health St. Helena94574, St. Helena United States
Connecticut
Hartford Healthcare06102, Hartford United States
Indiana
St Vincent Heart Center of Indiana46290, Indianapolis United States

Sponsors and collaborators

Medtronic Cardiac Surgery

Lead sponsor

Source ClinicalTrials.gov