Status:
TERMINATED
Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 F...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00111488
Start Date
June 1 2005
End Date
December 1 2006
Last Update
January 6 2016
Active Locations (21)
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1
Scripps Memorial/ Kaiser Permanente
La Jolla, California, United States, 92037
2
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
3
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
4
Mercy General Hospital
Sacramento, California, United States, 95819