Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent (CURE-AF/Perst)

• ClinicalTrials.gov Identifier: NCT00506493
• Recruitment Status: Completed
• First Posted: July 25, 2007
• Results First Posted: October 16, 2013
• Last Update Posted: January 13, 2014
• Sponsor: Medtronic Cardiovascular
• Information provided by (Responsible Party): Medtronic Cardiovascular

Study Description

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 persistent AF patients.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation	Device: Cardioblate Surgical Ablation System; Procedure: Surgical RF Ablation	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Persistent Study
• Study Start Date: September 2007
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: October 2011

Arms and Interventions

Intervention Details:

• Device: Cardioblate 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.

Outcome Measures

Primary Outcome Measures :

1. Efficacy Endpoint: The Percent of Patients Off Class I or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months [ Time Frame: 9 months ]
   Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours
2. 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 were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.

Secondary Outcome Measures :

1. Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 9 Months [ Time Frame: 9 months ]
2. Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure [ Time Frame: 9 months ]
   Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patients must have a documented history of persistent AF as defined by the ACC/AHA/ESC Guidelines: Characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days.

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 atrial ablation for AF, 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

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, 63310

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

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT00506493
• Other Study ID Numbers: CURE-AF/Persistent
• First Posted: July 25, 2007
• Results First Posted: October 16, 2013
• Last Update Posted: January 13, 2014
• Last Verified: December 2013

Keywords provided by Medtronic Cardiovascular:

Persistent Atrial Fibrillation Surgical RF Ablation; Perisistent Atrial Fibrillation; Surgical Ablation

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes