Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage

Phase 2

Terminated

• Conditions: Left Atrial Appendage Occlusion

• Registration Number: NCT00841529
• Lead Sponsor: Medtronic Cardiovascular

Brief Summary

The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Study Start: 2009-03
• Primary Completion: 2009-11
• Study Completion: 2010-06
• Status Verified: 2012-10
• Disposition First Submitted: 2012-10-01
• Disposition First Submitted QC: 2012-10-18
• Last Update Submitted: 2012-10-18
• Disposition First Posted: 2012-10-23
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subject is greater than or equal to 18 years of age and less than or equal to 80 years of age
• Concomitant indication for cardiac surgery for one or more of the following:mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, CABG (>=60 years of age), CABG (< 60 years of age with a history of atrial fibrillation), surgical ablation or Maze procedure
• The subject is willing and able to provide written informed consent and comply with study requirements
• The subject is not contra-indicated for intra-operative transesophageal echocardiogram (TEE)

Exclusion Criteria

• Thrombus in the LAA and/or left atrium
• Prior LAA isolation attempts
• Subject is unable to take an anticoagulant during the study follow-up period
• Subject is undergoing an emergency cardiac procedure
• Life expectancy of less than 12 months
• Pregnancy or desire to be pregnant within the 12 months of the study procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complete occlusion of the left atrial appendage	3 Months

Secondary Outcome Measures

Name	Time	Method
To evaluate the composite incidence rate of device-related adverse events	Discharge/30 days

Trial Locations

Locations (5)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Eisenhower Medical Center; 🇺🇸 Rancho Mirage, California, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Oklahoma Heart Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States

Aurora St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States