Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00111488
First received: May 20, 2005
Last updated: May 19, 2014
Last verified: May 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: May 19, 2014
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 August 19, 2014