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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT00431834
First received: February 2, 2007
Last updated: November 3, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Device: Cardioblate System Surgical Ablation System
Procedure: Surgical RF Ablation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Permanent Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Subject's heart rhythm was evaulated 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 ] [ Designated as safety issue: Yes ]
    Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.


Secondary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.


Enrollment: 75
Study Start Date: May 2007
Study Completion Date: August 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 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.
    Procedure: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431834

Locations
United States, Arizona
Southwest Heart and Lung
Phoenix, Arizona, United States, 85260
United States, California
East Bay Cardiovascular & Thoracic Associates
Concord, California, United States, 94520
University of Southern California
Los Angeles, California, United States, 90033
Eisenhower Medical Center
Palm Springs, California, United States, 92270
United States, Florida
Cardiac Surgical Associates of Florida
St. Petersburg, Florida, United States, 33701
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Minnesota
Mayo/St. Mary's Hospital
Rochester, Minnesota, United States, 55902
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
United States, New Mexico
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87102
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10075
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Inova Fairfax
Falls Church, Virginia, United States, 22042
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53515
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Principal Investigator: Thoralf Sundt, MD The Mayo Clinic- Rochester
  More Information

No publications provided by Medtronic Cardiovascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT00431834     History of Changes
Other Study ID Numbers: CURE-AF/Permanent
Study First Received: February 2, 2007
Results First Received: August 9, 2013
Last Updated: November 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiovascular:
Permanent Atrial Fibrillation Surgical RF Ablation
Permanent Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014