Clinical trial NCT00111488: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-05-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Freedom from atrial fibrillation at six months
measure: Composite major adverse event at one month
timeFrame: One month
Secondary outcomes:
measure: Composite Majour Adverse Events at three and 6 months
timeFrame: 3 months and 6 months
measure: Restoration of normal sinus rhythm at discharge
timeFrame: Hospital discharge
measure: Change in cardiac function at six month
timeFrame: 6 month
measure: Change in Quality of Life at six months
timeFrame: 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Memorial/ Kaiser Permanente
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Francis Hospital and Health Center
state: Indiana
city: Omaha
country: United States
facility: Alegent Health
state: Nebraska
city: Newark
country: United States
facility: St. Michael's Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Rochester
country: United States
facility: Univesity of Rochester Medical
state: New York
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Cardiopulmonary Research Science and Technology Institute
state: Texas
city: Dallas
country: United States
facility: Baylor University
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of VIrginia Health System
state: Virginia
city: Seattle
country: United States
facility: Virginia Masonic Clinic
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Heart Hospital
state: Wisconsin
city: Wausau
country: United States
facility: Wausau Heart and Lung Surgeons
state: Wisconsin
Study officials:
affiliation: Cardiopulmonary Research Science and Technology Institute
name: Michael Mack, MD
role: PRINCIPAL_INVESTIGATOR
References: