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

Phase 3

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT00431834
• Lead Sponsor: Medtronic Cardiovascular

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 permanent AF patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-02
• Study First Submitted QC: 2007-02-05
• Study First Posted: 2007-02-06
• Study Start: 2007-05
• Primary Completion: 2010-08
• Study Completion: 2011-08
• Disposition First Submitted: 2012-05-17
• Disposition First Submitted QC: 2012-05-17
• Disposition First Posted: 2012-10-05
• Status Verified: 2013-08
• Results First Submitted: 2013-08-09
• Results First Submitted QC: 2013-08-09
• Results First Posted: 2013-10-16
• Last Update Submitted: 2013-11-03
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines.

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

1. Wolff-Parkinson-White syndrome
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge	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.
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.	6 months	Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.

Secondary Outcome Measures

Name	Time	Method
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	6 months	Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.

Trial Locations

Locations (15)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Englewood Hospital and Medical Center; 🇺🇸 Englewood, New Jersey, United States

New Mexico Heart Institute; 🇺🇸 Albuquerque, New Mexico, United States

Southwest Heart and Lung; 🇺🇸 Phoenix, Arizona, United States

East Bay Cardiovascular & Thoracic Associates; 🇺🇸 Concord, California, United States

Cardiac Surgical Associates of Florida; 🇺🇸 St. Petersburg, Florida, United States

Inova Fairfax; 🇺🇸 Falls Church, Virginia, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Eisenhower Medical Center; 🇺🇸 Palm Springs, California, United States

Mayo/St. Mary's Hospital; 🇺🇸 Rochester, Minnesota, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Hospital of University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Aurora St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States