Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study

Study Overview
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Brief Summary
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This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat permanent AF patients.

Official Title
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Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Permanent Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Cardioblate System Surgical Ablation System
* Procedure: Surgical RF Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines. Concomitant indication (other than AF) for open-heart surgery for one or more of the following: Mitral valve repair or replacement Aortic valve repair or replacement Tricuspid valve repair or replacement Atrial septal defect (ASD) repair Patent foramen ovale (PFO) closure Coronary artery bypass procedures Greater than or equal to 18 years of age Able and willing to comply with study requirements by signing a consent form Must be able to take the anticoagulant warfarin (Coumadin) Exclusion Criteria: Wolff-Parkinson-White syndrome NYHA Class = IV Left ventricular ejection fraction ≤ 30% Need for emergent cardiac surgery (i.e. cardiogenic shock) Previous ablation for atrial fibrillation, AV-nodal ablation, or surgical Maze procedure Contraindication for anticoagulation therapy Left atrial diameter > 7.0 cm Preoperative need for an intra-aortic balloon pump or intravenous inotropes Renal failure requiring dialysis or hepatic failure Life expectancy of less than one year Pregnancy or desire to be pregnant within 12 months of the study treatment. Current diagnosis of active systemic infection Documented MI 6 weeks prior to study enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardioblate System Surgical Ablation System|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.|
|Procedure: Surgical RF Ablation|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Endpoint: The Percent of Patients Off Class I and/or III Antiarrhythmic Drugs and Out of Atrial Fibrillation as Determined by 24 Hour Holter Recording Conducted at 6 Months Postoperatively. | Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours. | 6 months | 
| Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge | Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury. | 30 days post procedure or hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 6 Months |  | 6 months | 
| Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure | Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Permanent Atrial Fibrillation Surgical RF Ablation, Permanent Atrial Fibrillation