Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

Study Overview
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Brief Summary
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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 FLEX® Microwave Surgical Ablation System in the treatment of permanent atrial fibrillation (AF).

Official Title
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Randomized Study of Surgical Ablation With Microwave Energy for the Treatment of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Flex 4 and Generator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Flex 4 and Generator|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial fibrillation at six months |  |  | 
| Composite major adverse event at one month |  | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Majour Adverse Events at three and 6 months |  | 3 months and 6 months | 
| Restoration of normal sinus rhythm at discharge |  | Hospital discharge | 
| Change in cardiac function at six month |  | 6 month | 
| Change in Quality of Life at six months |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation