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

NCT00506493 | Completed Phase 3 Results DMC

• 1 other identifier: CURE-AF/Persistent
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 15

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.

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours

  9 months

• Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 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.

  30 days post procedure or hospital discharge

Secondary Outcomes (2)

• 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

  9 months

• Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure

  9 months

Interventions

Cardioblate Surgical Ablation System DEVICE

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.

Surgical RF Ablation PROCEDURE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 atrial ablation for AF, 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

Sponsors & Collaborators

• Medtronic Cardiac Surgery: lead

Study Sites (15)

Southwest Heart and Lung

Phoenix, Arizona, 85260, United States

Location

East Bay Cardiovascular & Thoracic Associates

Concord, California, 94520, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Eisenhower Medical Center

Palm Springs, California, 92270, United States

Location

Cardiac Surgical Associates of Florida

St. Petersburg, Florida, 33701, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Mayo/St. Mary's Hospital

Rochester, Minnesota, 55902, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63310, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Inova Fairfax

Falls Church, Virginia, 22042, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53515, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

* Slow/delayed enrollment * Medical management of subjects by non-investigators leading to medication washout protocol deviations * Missing endpoint data (attrition) due to cohort demographics (old age, dementia, relocation, etc.)

Results Point of Contact

• Title: Kristin Lawman
• Organization: Medtronic, Inc.

kristin.j.lawman@medtronic.com

763-514-9809

Study Officials

• Thoralf Sundt, MD

  The Mayo Clinic- Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2007
• First Posted: July 25, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 29, 2023
• Results First Posted: October 16, 2013

Record last verified: 2023-11

Locations

US (15)