Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

Phase 3

Terminated

• Conditions: Atrial Fibrillation

• Registration Number: NCT00111488
• Lead Sponsor: Boston Scientific Corporation

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 available

Study Timeline

• Study First Submitted: 2005-05-20
• Study First Submitted QC: 2005-05-20
• Study First Posted: 2005-05-23
• Study Start: 2005-06
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2014-05
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation at six months
Composite major adverse event at one month	One month

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life at six months	6 months
Composite Majour Adverse Events at three and 6 months	3 months and 6 months
Change in cardiac function at six month	6 month
Restoration of normal sinus rhythm at discharge	Hospital discharge

Trial Locations

Locations (21)

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

Mercy General Hospital; 🇺🇸 Sacramento, California, United States

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

St. Francis Hospital and Health Center; 🇺🇸 Indianapolis, Indiana, United States

Alegent Health; 🇺🇸 Omaha, Nebraska, United States

St. Michael's Medical Center; 🇺🇸 Newark, New Jersey, United States

Valley Hospital; 🇺🇸 Ridgewood, New Jersey, United States

Scroll for more (11 remaining)