Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

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

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).

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Flex 4 and Generator

• Study Type: Interventional
• Enrollment: 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Memorial/ Kaiser Permanente
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Medical Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Methodist Hospital
    • Indianapolis, Indiana, United States, 46237
      • St. Francis Hospital and Health Center
  • Nebraska
    • Omaha, Nebraska, United States, 48910
      • Alegent Health
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • St. Michael's Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
  • New York
    • New York, New York, United States, 10021
      • Lenox Hill Hospital
    • Rochester, New York, United States, 14642
      • Univesity of Rochester Medical
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Cardiopulmonary Research Science and Technology Institute
    • Dallas, Texas, United States, 75246
      • Baylor University
    • Fort Worth, Texas, United States, 76104
      • Plaza Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
  • Washington
    • Seattle, Washington, United States, 98111
      • Virginia Masonic Clinic
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53210
      • Wisconsin Heart Hospital
    • Wausau, Wisconsin, United States, 54401
      • Wausau Heart and Lung Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom from atrial fibrillation at six months
Composite major adverse event at one month	One month

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Michael Mack, MD, Cardiopulmonary Research Science and Technology Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: May 20, 2005
• First Submitted That Met QC Criteria: May 20, 2005
• First Posted (Estimate): May 23, 2005

Study Record Updates

• Last Update Posted (Estimate): January 6, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: VR2045885