Left Atrial Appendage Occlusion
Conditions
Keywords
left atrial appendage, LAA, atrial fibrillation, AF
Brief summary
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA
Interventions
DEVICEMedtronic LAA Occlusion Device
Placement of the occlusion band on the LAA
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete occlusion of the left atrial appendage | 3 Months |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the composite incidence rate of device-related adverse events | Discharge/30 days |
Countries
United States
Outcome results
None listed