Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study
NCT ID: NCT00431834
Last Updated: 2013-11-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2007-05-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Greater than or equal to 18 years of age
4. Able and willing to comply with study requirements by signing a consent form
5. Must be able to take the anticoagulant warfarin (Coumadin)
Exclusion Criteria
2. NYHA Class = IV
3. Left ventricular ejection fraction ≤ 30%
4. Need for emergent cardiac surgery (i.e. cardiogenic shock)
5. Previous ablation for atrial fibrillation, AV-nodal ablation, or surgical Maze procedure
6. Contraindication for anticoagulation therapy
7. Left atrial diameter \> 7.0 cm
8. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
9. Renal failure requiring dialysis or hepatic failure
10. Life expectancy of less than one year
11. Pregnancy or desire to be pregnant within 12 months of the study treatment.
12. Current diagnosis of active systemic infection
13. Documented MI 6 weeks prior to study enrollment
18 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Thoralf Sundt, MD
Role: PRINCIPAL_INVESTIGATOR
The Mayo Clinic- Rochester
Locations
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Southwest Heart and Lung
Phoenix, Arizona, United States
East Bay Cardiovascular & Thoracic Associates
Concord, California, United States
University of Southern California
Los Angeles, California, United States
Eisenhower Medical Center
Palm Springs, California, United States
Cardiac Surgical Associates of Florida
St. Petersburg, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Mayo/St. Mary's Hospital
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
Lenox Hill Hospital
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States
Inova Fairfax
Falls Church, Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Damiano RJ Jr, Badhwar V, Acker MA, Veeragandham RS, Kress DC, Robertson JO, Sundt TM. The CURE-AF trial: a prospective, multicenter trial of irrigated radiofrequency ablation for the treatment of persistent atrial fibrillation during concomitant cardiac surgery. Heart Rhythm. 2014 Jan;11(1):39-45. doi: 10.1016/j.hrthm.2013.10.004. Epub 2013 Oct 31.
Other Identifiers
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CURE-AF/Permanent
Identifier Type: -
Identifier Source: org_study_id