Study Stopped
Slow enrollment
Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation
Randomized Study of Surgical Ablation With Microwave Energy for the Treatment of Atrial Fibrillation
1 other identifier
interventional
200
1 country
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 atrial-fibrillation
Started Jun 2005
Shorter than P25 for phase_3 atrial-fibrillation
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2005
CompletedFirst Posted
Study publicly available on registry
May 23, 2005
CompletedStudy Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 6, 2016
May 1, 2014
1.5 years
May 20, 2005
January 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Freedom from atrial fibrillation at six months
Composite major adverse event at one month
One month
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Scripps Memorial/ Kaiser Permanente
La Jolla, California, 92037, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Methodist Hospital
Indianapolis, Indiana, 46202, United States
St. Francis Hospital and Health Center
Indianapolis, Indiana, 46237, United States
Alegent Health
Omaha, Nebraska, 48910, United States
St. Michael's Medical Center
Newark, New Jersey, 07102, United States
Valley Hospital
Ridgewood, New Jersey, 07450, United States
Lenox Hill Hospital
New York, New York, 10021, United States
Univesity of Rochester Medical
Rochester, New York, 14642, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, 75230, United States
Baylor University
Dallas, Texas, 75246, United States
Plaza Medical Center
Fort Worth, Texas, 76104, United States
University of VIrginia Health System
Charlottesville, Virginia, 22908, United States
Virginia Masonic Clinic
Seattle, Washington, 98111, United States
Wisconsin Heart Hospital
Milwaukee, Wisconsin, 53210, United States
Wausau Heart and Lung Surgeons
Wausau, Wisconsin, 54401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Mack, MD
Cardiopulmonary Research Science and Technology Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2005
First Posted
May 23, 2005
Study Start
June 1, 2005
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
January 6, 2016
Record last verified: 2014-05