Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Persistent Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Medtronic Cardiac Surgery
- Enrollment
- 75
- Locations
- 15
- Primary Endpoint
- Efficacy Endpoint: The Percent of Patients Off Class I or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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 persistent AF patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have a documented history of persistent AF as defined by the ACC/AHA/ESC Guidelines: Characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days.
- •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
Exclusion Criteria
- •Wolff-Parkinson-White syndrome
- •NYHA Class = IV
- •Left ventricular ejection fraction ≤ 30%
- •Need for emergent cardiac surgery (i.e. cardiogenic shock)
- •Previous atrial ablation for AF, 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
Outcomes
Primary Outcomes
Efficacy Endpoint: The Percent of Patients Off Class I or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months
Time Frame: 9 months
Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours
Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
Time Frame: 30 days post procedure or hospital discharge
Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.
Secondary Outcomes
- Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 9 Months(9 months)
- Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure(9 months)