Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study
Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Permanent Study
1 other identifier
interventional
75
1 country
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 permanent AF patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 atrial-fibrillation
Started May 2007
Typical duration for phase_3 atrial-fibrillation
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2007
CompletedFirst Posted
Study publicly available on registry
February 6, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
October 16, 2013
CompletedNovember 27, 2013
August 1, 2013
3.3 years
February 2, 2007
August 9, 2013
November 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
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 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 6 Months
6 months
Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure
6 months
Interventions
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.
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
You may qualify if:
- Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines.
- 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 ablation for atrial fibrillation, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Southwest Heart and Lung
Phoenix, Arizona, 85260, United States
East Bay Cardiovascular & Thoracic Associates
Concord, California, 94520, United States
University of Southern California
Los Angeles, California, 90033, United States
Eisenhower Medical Center
Palm Springs, California, 92270, United States
Cardiac Surgical Associates of Florida
St. Petersburg, Florida, 33701, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Mayo/St. Mary's Hospital
Rochester, Minnesota, 55902, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Inova Fairfax
Falls Church, Virginia, 22042, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53515, United States
Related Publications (1)
Damiano RJ Jr, Badhwar V, Acker MA, Veeragandham RS, Kress DC, Robertson JO, Sundt TM. The CURE-AF trial: a prospective, multicenter trial of irrigated radiofrequency ablation for the treatment of persistent atrial fibrillation during concomitant cardiac surgery. Heart Rhythm. 2014 Jan;11(1):39-45. doi: 10.1016/j.hrthm.2013.10.004. Epub 2013 Oct 31.
PMID: 24184028DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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.
Study Officials
- PRINCIPAL INVESTIGATOR
Thoralf Sundt, MD
The Mayo Clinic- Rochester
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
February 2, 2007
First Posted
February 6, 2007
Study Start
May 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2011
Last Updated
November 27, 2013
Results First Posted
October 16, 2013
Record last verified: 2013-08