Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

Boston Scientific

Status and phase

Terminated

Phase 3

Conditions

Atrial Fibrillation

Treatments

Device: Flex 4 and Generator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00111488

VR2045885

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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