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

November 3, 2013 updated by: Medtronic Cardiovascular

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.
6 months
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
Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.
30 days post procedure or hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure
Time Frame: 6 months
Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

  • Principal Investigator: Thoralf Sundt, MD, The Mayo Clinic- Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

February 2, 2007

First Submitted That Met QC Criteria

February 5, 2007

First Posted (Estimate)

February 6, 2007

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 3, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CURE-AF/Permanent

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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