Status:
COMPLETED
Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Cardiob...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00431834
Start Date
May 1 2007
End Date
August 1 2011
Last Update
November 27 2013
Active Locations (15)
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1
Southwest Heart and Lung
Phoenix, Arizona, United States, 85260
2
East Bay Cardiovascular & Thoracic Associates
Concord, California, United States, 94520
3
University of Southern California
Los Angeles, California, United States, 90033
4
Eisenhower Medical Center
Palm Springs, California, United States, 92270