Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
Medtronic Cardiac Surgery
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).
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 United States (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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureSurgical Ablation
In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.
- DeviceCardioblate and Cryoflex hand held devices
The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.
Locations (15)
- Stanford Hospitals and ClinicPalo Alto, California
- Adventist Health St. HelenaSt. Helena, California
- Hartford HealthcareHartford, Connecticut
- St Vincent Heart Center of IndianaIndianapolis, Indiana
- Massachusetts General HospitalBoston, Massachusetts
- Corewell HealthGrand Rapids, Michigan