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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 20, 2005

Last Updated Date

August 31, 2012

Start Date ^ICMJE

June 2005

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Freedom from atrial fibrillation at six months
Composite major adverse event at one month [ Time Frame: One month ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00111488 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Device: Flex 4 and Generator

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

200

Completion Date

December 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00111488

Other Study ID Numbers ^ICMJE

VR2045885

Has Data Monitoring Committee

Not Provided

Responsible Party

Guidant Corporation

Study Sponsor ^ICMJE

Guidant Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael Mack, MD

Cardiopulmonary Research Science and Technology Institute

Information Provided By

Guidant Corporation

Verification Date

August 2012

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

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