Atrial Fibrillation
Conditions
Keywords
atrial fibrillation
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 FLEX® Microwave Surgical Ablation System in the treatment of permanent atrial fibrillation (AF).
Interventions
DEVICEFlex 4 and Generator
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from atrial fibrillation at six months | — |
| Composite major adverse event at one month | One month |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed