Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00111488
• Other study ID #: VR2045885
• Status: Terminated
• Phase: Phase 3
• First received: May 20, 2005
• Last updated: January 5, 2016
• Start date: June 2005
• Est. completion date: December 2006

Study information

• Verified date: May 2014
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Flex 4 and Generator

Locations

Country	Name	City	State
United States	Piedmont Hospital	Atlanta	Georgia
United States	University of VIrginia Health System	Charlottesville	Virginia
United States	Baylor University	Dallas	Texas
United States	Cardiopulmonary Research Science and Technology Institute	Dallas	Texas
United States	Plaza Medical Center	Fort Worth	Texas
United States	Methodist Hospital	Indianapolis	Indiana
United States	St. Francis Hospital and Health Center	Indianapolis	Indiana
United States	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	Wisconsin Heart Hospital	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Lenox Hill Hospital	New York	New York
United States	St. Michael's Medical Center	Newark	New Jersey
United States	Alegent Health	Omaha	Nebraska
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Valley Hospital	Ridgewood	New Jersey
United States	Univesity of Rochester Medical	Rochester	New York
United States	Mercy General Hospital	Sacramento	California
United States	Virginia Masonic Clinic	Seattle	Washington
United States	Wausau Heart and Lung Surgeons	Wausau	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation at six months
Primary	Composite major adverse event at one month		One month	Yes
Secondary	Composite Majour Adverse Events at three and 6 months		3 months and 6 months	Yes
Secondary	Restoration of normal sinus rhythm at discharge		Hospital discharge	No
Secondary	Change in cardiac function at six month		6 month	No
Secondary	Change in Quality of Life at six months		6 months	No