Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT00111488
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The purpose of the Randomized Study of Surgical Ablation with Microwave Energy for the Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and effectiveness of the Guidant FLEXยฎ Microwave Surgical Ablation System in the treatment of permanent atrial fibrillation (AF).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 200
- Patient age >= 18 years
- Documented permanent AF (for at least three months)
- Scheduled for an open chest cardiac surgery for the primary indication of mitral valve repair or replacement
- Has been informed of the nature of the study, agrees to its provisions, and provided written informed consent, which was approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site
- Cerebral vascular accident (CVA, stroke) or transient ischemic attack (TIA) within the previous 6 months
- Myocardial infarction within the previous 6 weeks
- Documented history of pulmonary vein stenosis
- Previous ablation attempt for AF
- Previous thoracic procedures
- Left atrial size > 7.0 cm
- Left ventricular ejection fraction < 30%
- Presence of left atrial or left atrial appendage thrombi
- Esophageal fistula or other stricture, untreated esophagitis, varices, dysphagia or odynophagia contraindicating transesophageal echocardiography
- Known allergy or contraindication to warfarin therapy
- Known allergy or contraindication to antiarrhythmic (Classes IA, IC, III) therapy
- Other comorbidity with reduced life expectancy of less than 1 year or protocol noncompliance that would limit follow-up
- Geographically remote or unable to return for follow-up examinations
- Pregnant or planning to become pregnant during the study
- Enrolled in any concurrent study, without Guidant written approval, that may confound the results of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Freedom from atrial fibrillation at six months Composite major adverse event at one month One month
- Secondary Outcome Measures
Name Time Method Change in Quality of Life at six months 6 months Composite Majour Adverse Events at three and 6 months 3 months and 6 months Change in cardiac function at six month 6 month Restoration of normal sinus rhythm at discharge Hospital discharge
Trial Locations
- Locations (21)
St. Michael's Medical Center
๐บ๐ธNewark, New Jersey, United States
Baylor University
๐บ๐ธDallas, Texas, United States
Virginia Masonic Clinic
๐บ๐ธSeattle, Washington, United States
Piedmont Hospital
๐บ๐ธAtlanta, Georgia, United States
Scripps Memorial/ Kaiser Permanente
๐บ๐ธLa Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
๐บ๐ธLos Angeles, California, United States
Mercy General Hospital
๐บ๐ธSacramento, California, United States
Valley Hospital
๐บ๐ธRidgewood, New Jersey, United States
Lenox Hill Hospital
๐บ๐ธNew York, New York, United States
Providence St. Vincent Medical Center
๐บ๐ธPortland, Oregon, United States
Univesity of Rochester Medical
๐บ๐ธRochester, New York, United States
Cardiopulmonary Research Science and Technology Institute
๐บ๐ธDallas, Texas, United States
Plaza Medical Center
๐บ๐ธFort Worth, Texas, United States
University of VIrginia Health System
๐บ๐ธCharlottesville, Virginia, United States
Wisconsin Heart Hospital
๐บ๐ธMilwaukee, Wisconsin, United States
Wausau Heart and Lung Surgeons
๐บ๐ธWausau, Wisconsin, United States
Alegent Health
๐บ๐ธOmaha, Nebraska, United States
Methodist Hospital
๐บ๐ธIndianapolis, Indiana, United States
St. Francis Hospital and Health Center
๐บ๐ธIndianapolis, Indiana, United States
Vanderbilt University Medical Center
๐บ๐ธNashville, Tennessee, United States
Long Beach Memorial Medical Center
๐บ๐ธLong Beach, California, United States