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

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT00431834

Run by

Medtronic Cardiovascular

People needed

75

Starts

2007-05-01

Expected to finish

2011-08-01

Last updated by the study team

2013-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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