cardiac rhythm disorders heart failure
Conditions
Interventions
In the participating patients, the left atrial appendage (LAA) will be occluded
using the Cardioblate® Closure* Device, during minimally invasive cardiac
surgery. The occlusion of the LAA will be co
Sponsors
Cardiovascular Department SHD/RST
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects who meet the following criteria should be considered for the study: 1) >18 and 60 years of age e. CABG for subjects
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria should not be considered for the study: 1) Thrombus in LAA and/or LA 2) Prior LAA isolation attempt(s) 3) Patient is contraindicated for an intra-operative transesophageal echocardiogram (TEE) 4) Unable to take an anticoagulant during the study follow-up period 5) Subject is undergoing an emergency cardiac procedure 6) Life expectancy of less than 12 months 7) Pregnancy or desire to be pregnant within 12 months of the study procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint The primary efficacy endpoint will be effective occlusion of the LAA at 3-months follow-up using a computed tomography (CT) scan for those devices placed successfully. A contrast enhanced CT-scan provides a better spatial resolution and a higher sensitivity for blood communication than the classic echocardiography. The criteria for successful device placement and occlusion are the following: Successful device placement Placement of the Closure device is considered successful if the band is placed 4-6 mm in diameter detection of blood/contrast communication in all views into the LAA Severe: > 6 mm in diameter detection of blood/contrast communication in all views into the LAA Primary safety endpoint The primary safety endpoint is the combined incidence of device-related adverse events that occur during device placement, or in the early post-operative period (30 days post-surgery or hospital discharge, whichever is longer). The device-related adverse events that could be expected to occur and are the primary safety endpoints are: • LAA tears requiring surgical repair • Bleeding requiring surgical intervention • Unintentional tissue damage requiring surgical intervention • Re-operation due to band displacement • Incomplete occlusion of the LAA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint The secondary objective is to evaluate successful placement of the band. The secondary endpoint is the successful placement of the band, defined as 95% of the devices being properly placed onto the base of LAA ( | — |
Countries
Netherlands
Outcome results
None listed