Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation - Full Text View

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 III

Genetics Home Reference related topics:

Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Randomized Study of Surgical Ablation With Microwave Energy for the Treatment of Atrial Fibrillation

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

Estimated Enrollment:	200
Study Start Date:	June 2005

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
	Long Beach Memorial Medical Center
	Long Beach, California, United States, 90806
	Scripps Memorial/ Kaiser Permanente
	La Jolla, California, United States, 92037
	Mercy General Hospital
	Sacramento, California, United States, 95819
	Kaiser Permanente Los Angeles Medical Center
	Los Angeles, California, United States, 90027

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
	Valley Hospital
	Ridgewood, New Jersey, United States, 07450
	St. Michael's Medical Center
	Newark, New Jersey, United States, 07102

United States, New York
	Univesity of Rochester Medical
	Rochester, New York, United States, 14642
	Lenox Hill Hospital
	New York, New York, United States, 10021

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
	Plaza Medical Center
	Fort Worth, Texas, United States, 76104
	Cardiopulmonary Research Science and Technology Institute
	Dallas, Texas, United States, 75230

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

Link to study website This link exits the ClinicalTrials.gov site

Study ID Numbers:	VR2045885
First Received:	May 20, 2005
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00111488
Health Authority:	United States: Food and Drug Administration

Keywords provided by Guidant Corporation:

atrial fibrillation

Study placed in the following topic categories:

Heart Diseases

Atrial Fibrillation

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2008

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00111488