paralysis Stroke
Conditions
Interventions
Sponsors
Keystone Heart
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The patient must be * 18 years of age. 2. The patient meets indications for TAVI procedure. 3. The patient has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) 4. The patient is willing to comply with specified follow-up evaluations.
Exclusion criteria
Exclusion criteria: 1.Patients undergoing TAVI via the trans-axillary, transapical, subclavian, or direct aortic route 2 Patients with impaired renal function (estimated Glomerular Filtration Rate [eGFR]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: * High-intensity transient signals detected by transcranial Doppler (TCD), during the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Performance Endpoints: * Successful device deployment, defined as ability to access the aortic arch with the TriGUARD* 3 delivery catheter and deploy the device from the delivery catheter into the aortic arch. * Successful Device positioning, defined as ability to position the TriGUARD* 3 device in the aortic arch to cover all major cerebral arteries * Successful device retrieval, defined as ability to retrieve the TriGUARD* 3 device and remove the intact delivery system * Device success, defined as successful device deployment, successful device positioning, complete 3-vessel coverage throughout the procedure, and successful device retrieval. Secondary Safety Endpoints * Cardiovascular mortality * Ischemic stroke o Disabling o Non-disabling * Life threatening (or disabling) bleeding * Acute kidney injury (Stage 3) * Major vascular complications (excluding TAVI access site-related complications) Mortality: * All-cause mortality o Cardiovascular mortality o Non-cardiovascular mortality Stroke (VARC-2 defined), sub-classified as ischemic and hemorrhagic * All stroke * Transient ischemic attack (TIA) Bleeding Complications: * Life-threatening bleeding (VARC-2) * Major bleeding related to TriGUARD 3 Acute Kidney Injury (AKI Classification): Vascular Complications: * Major vascular complications related to TriGUARD 3 * Major vascular complications related to TAVI | — |
Countries
Netherlands
Outcome results
None listed