NL-OMON40150
Completed
Phase 2
A prospective, single arm feasibility pilot study to evaluate the safety and performance of the TriGuard*-HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR) - DEFLECT II
Keystone Heart0 sites15 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- brain infarction
- Sponsor
- Keystone Heart
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The patient must be \>\= 18 years of age.
- •2\. The patient meets indications for TAVI procedure.
- •3\. The patient is willing to comply with specified follow\-up evaluations.
Exclusion Criteria
- •1\. Patients undergoing TAVI via the trans\-axillary, subclavian, or direct aortic route
- •2\. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child\-bearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
- •3\. Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI \> 72 hours preceding the index procedure and CK and CK\-MB have not returned to normal limits at the time of procedure.
- •4\. Patients who are currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate\-unresponsive prolonged chest pain.
- •5\. Patients with impaired renal function (estimated Glomerular Filtration Rate \[eGFR] \<30, calculated from serum creatinine by the Cockcroft\-Gault formula).
- •6\. Patients with torturous/unsuitable anatomy as related to major cerebral arteries in the aortic arch that may interfere with device deployment or remain deployed.
- •7\. Patients with a platelet count \<100\.000 cells/mm³ or \>700\.000 cells/mm³ or a WBC \<3000 cells/mm³ within 7 days prior to index procedure.
- •8\. Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti\-platelet and/or anticoagulant therapy is contraindicated, or will refuse transfusion.
- •9\. Patients who have received any organ transplant or are on a waiting list for any organ transplant.
- •10\. Poor anticipetid fluoroscopic visualization due to obesity or other medical reason
Outcomes
Primary Outcomes
Not specified
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