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

Covidien

Status and phase: Terminated; Phase 2

Conditions: Left Atrial Appendage Occlusion

Treatments: Device: Medtronic LAA Occlusion Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00841529

D02940

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)