Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study
This study has been completed.
Sponsor:
Medtronic Cardiovascular
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT00431834
First received: February 2, 2007
Last updated: October 1, 2012
Last verified: October 2012
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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 or III antiarrhythmic drugs and out of AF as determined by 24 hour Holter recording at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 ]
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 ]
| 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:
- 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)
Exclusion Criteria:
- 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
Contacts and Locations
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
| Responsible Party: | Medtronic Cardiovascular |
| ClinicalTrials.gov Identifier: | NCT00431834 History of Changes |
| Other Study ID Numbers: | CURE-AF/Permanent |
| Study First Received: | February 2, 2007 |
| Last Updated: | October 1, 2012 |
| 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 May 23, 2013