cardiac valve disorders cerebral and non-cerebral embolism
Conditions
Interventions
Screening, procedure, in-hospital safety assessment, 30-day telephone follow-up.
Interim analysis for in-hospital device-related adverse events by the review
committee after 10patients.
-Screening p
Sponsors
Emboline Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The patient must be 18 years and older. 2. The patient must meet the indications for the TAVR procedure. 3. The patient is willing to comply with protocol-specified follow-up evaluations. 4. The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC)
Exclusion criteria
Exclusion criteria: 1. Patients with an ascending aortic diameter >40 mm, or a descending aorta >27 mm. 2. Patients with the linear distance from the femoral access site to the aortic valve root greater than 85 cm. 3. Patients not undergoing TAVR via the trans-femoral route. 4. Patients that are contraindicated for anticoagulant and/or antiplatelet therapy. 5. Patients with uncorrected bleeding disorders. 6. Pregnant or nursing subjects, or subjects who intend to become pregnant during the term of the study. 7. Patients with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure (according to definition) or AMI >30 days preceding the index procedure, in whom either troponin levels, or CK (creatine kinase) and CK-MB (creatine kinase-Muscle Brain) have not returned to within normal limits at the time of procedure. 8. Patients with known other mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year. 9. Patients with severe allergy to heparin or known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, and/or contrast sensitivity that cannot be adequately pre- medicated. 10. Patients with a history of a stroke or transient ischemic attack(TIA) within the prior 6 months. 11. Patients with an active peptic ulcer or history of upper gastrointestinal(GI) bleeding within the prior 3 months. 12. Patients with renal failure (estimated Glomerular Filtration Rate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of 30-day MACCE, defined as the composite of death, stroke, or Stage 3 acute kidney injury (AKI) Performance: Technical performance (technical success) is defined as the ability to successfully (without device malfunction): * Ability to access the aortic arch with the delivery catheter; * Ability to position the Emboliner across the aortic arch * Ability to retrieve and remove the Emboliner without damage (as reported by the Investigator) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Incidence of in-hospital investigational device-related serious adverse events * Incidence of investigational device-related serious adverse events at 30 days * Incidence of adverse procedure (non-device) related events at 30 days * Minimal interference to the TAVR procedure as determined by the investigator * User feedback on ease of preparation, delivery, placement, and control of the device during the procedure * Presence of captured debris in the Emboliner filter after retrieval * Histopathological characterization of captured debris size, volume, morphology and composition | — |
Countries
Netherlands
Outcome results
None listed