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: August 31, 2012
Last verified: August 2012

May 20, 2005
August 31, 2012
June 2005
December 2006   (final data collection date for primary outcome measure)
  • Freedom from atrial fibrillation at six months
  • Composite major adverse event at one month [ Time Frame: One month ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00111488 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Atrial Fibrillation
Device: Flex 4 and Generator
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00111488
VR2045885
Not Provided
Guidant Corporation
Guidant Corporation
Not Provided
Principal Investigator: Michael Mack, MD Cardiopulmonary Research Science and Technology Institute
Guidant Corporation
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP