Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation
This study has been terminated.
(Slow enrollment)
Sponsor:
Guidant Corporation
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00111488
First received: May 20, 2005
Last updated: August 31, 2012
Last verified: August 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Device: Flex 4 and Generator |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Randomized Study of Surgical Ablation With Microwave Energy for the Treatment of Atrial Fibrillation |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Guidant Corporation:
Primary Outcome Measures:
- Freedom from atrial fibrillation at six months
- Composite major adverse event at one month [ Time Frame: One month ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Composite Majour Adverse Events at three and 6 months [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: Yes ]
- Restoration of normal sinus rhythm at discharge [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
- Change in cardiac function at six month [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- Change in Quality of Life at six months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2005 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111488
Locations
| United States, California | |
| Scripps Memorial/ Kaiser Permanente | |
| La Jolla, California, United States, 92037 | |
| Long Beach Memorial Medical Center | |
| Long Beach, California, United States, 90806 | |
| Kaiser Permanente Los Angeles Medical Center | |
| Los Angeles, California, United States, 90027 | |
| Mercy General Hospital | |
| Sacramento, California, United States, 95819 | |
| United States, Georgia | |
| Piedmont Hospital | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Indiana | |
| Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| St. Francis Hospital and Health Center | |
| Indianapolis, Indiana, United States, 46237 | |
| United States, Nebraska | |
| Alegent Health | |
| Omaha, Nebraska, United States, 48910 | |
| United States, New Jersey | |
| St. Michael's Medical Center | |
| Newark, New Jersey, United States, 07102 | |
| Valley Hospital | |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New York | |
| Lenox Hill Hospital | |
| New York, New York, United States, 10021 | |
| Univesity of Rochester Medical | |
| Rochester, New York, United States, 14642 | |
| United States, Oregon | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Baylor University | |
| Dallas, Texas, United States, 75246 | |
| Cardiopulmonary Research Science and Technology Institute | |
| Dallas, Texas, United States, 75230 | |
| Plaza Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| United States, Virginia | |
| University of VIrginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| Virginia Masonic Clinic | |
| Seattle, Washington, United States, 98111 | |
| United States, Wisconsin | |
| Wisconsin Heart Hospital | |
| Milwaukee, Wisconsin, United States, 53210 | |
| Wausau Heart and Lung Surgeons | |
| Wausau, Wisconsin, United States, 54401 | |
Sponsors and Collaborators
Guidant Corporation
Investigators
| Principal Investigator: | Michael Mack, MD | Cardiopulmonary Research Science and Technology Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Guidant Corporation |
| ClinicalTrials.gov Identifier: | NCT00111488 History of Changes |
| Other Study ID Numbers: | VR2045885 |
| Study First Received: | May 20, 2005 |
| Last Updated: | August 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Guidant Corporation:
|
atrial fibrillation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013