Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

Stopped early · Phase 3

Conditions studied: Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT00111488

Run by

Boston Scientific Corporation

People needed

200

Starts

2005-06-01

Expected to finish

2006-12-01

Last updated by the study team

2016-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Memorial/ Kaiser Permanente — La Jolla, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Mercy General Hospital — Sacramento, California, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Methodist Hospital — Indianapolis, Indiana, United States
• St. Francis Hospital and Health Center — Indianapolis, Indiana, United States
• Alegent Health — Omaha, Nebraska, United States
• St. Michael's Medical Center — Newark, New Jersey, United States
• Valley Hospital — Ridgewood, New Jersey, United States
• Lenox Hill Hospital — New York, New York, United States
• Univesity of Rochester Medical — Rochester, New York, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Cardiopulmonary Research Science and Technology Institute — Dallas, Texas, United States
• Baylor University — Dallas, Texas, United States
• Plaza Medical Center — Fort Worth, Texas, United States
• University of VIrginia Health System — Charlottesville, Virginia, United States
• Virginia Masonic Clinic — Seattle, Washington, United States
• Wisconsin Heart Hospital — Milwaukee, Wisconsin, United States
• Wausau Heart and Lung Surgeons — Wausau, Wisconsin, United States

Full record on ClinicalTrials.gov

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