search
Back to results

Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Flex 4 and Generator
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Memorial/ Kaiser Permanente
  • Long Beach Memorial Medical Center
  • Kaiser Permanente Los Angeles Medical Center
  • Mercy General Hospital
  • Piedmont Hospital
  • Methodist Hospital
  • St. Francis Hospital and Health Center
  • Alegent Health
  • St. Michael's Medical Center
  • Valley Hospital
  • Lenox Hill Hospital
  • Univesity of Rochester Medical
  • Providence St. Vincent Medical Center
  • Vanderbilt University Medical Center
  • Cardiopulmonary Research Science and Technology Institute
  • Baylor University
  • Plaza Medical Center
  • University of VIrginia Health System
  • Virginia Masonic Clinic
  • Wisconsin Heart Hospital
  • Wausau Heart and Lung Surgeons

Outcomes

Primary Outcome Measures

Freedom from atrial fibrillation at six months
Composite major adverse event at one month

Secondary Outcome Measures

Composite Majour Adverse Events at three and 6 months
Restoration of normal sinus rhythm at discharge
Change in cardiac function at six month
Change in Quality of Life at six months

Full Information

First Posted
May 20, 2005
Last Updated
January 5, 2016
Sponsor
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00111488
Brief Title
Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation
Official Title
Randomized Study of Surgical Ablation With Microwave Energy for the Treatment of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Flex 4 and Generator
Primary Outcome Measure Information:
Title
Freedom from atrial fibrillation at six months
Title
Composite major adverse event at one month
Time Frame
One month
Secondary Outcome Measure Information:
Title
Composite Majour Adverse Events at three and 6 months
Time Frame
3 months and 6 months
Title
Restoration of normal sinus rhythm at discharge
Time Frame
Hospital discharge
Title
Change in cardiac function at six month
Time Frame
6 month
Title
Change in Quality of Life at six months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Mack, MD
Organizational Affiliation
Cardiopulmonary Research Science and Technology Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Memorial/ Kaiser Permanente
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Francis Hospital and Health Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Alegent Health
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
48910
Country
United States
Facility Name
St. Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Univesity of Rochester Medical
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Cardiopulmonary Research Science and Technology Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Baylor University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Plaza Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of VIrginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Masonic Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
Facility Name
Wisconsin Heart Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53210
Country
United States
Facility Name
Wausau Heart and Lung Surgeons
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

We'll reach out to this number within 24 hrs