A prospective, single arm feasibility pilot study to evaluate the safety and performance of the TriGUARD*3 Embolic Protection Device in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) - TriGUARD3 First in man

Keystone Heart0 sites10 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 24, 2018

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Keystone Heart

•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.

•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] \<30, calculated from serum creatinine by the Cockcroft\-Gault formula).
•3\.Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months.
•4\.Patients with severe peripheral arterial disease that precludes the delivery sheath vascular access.
•5\.Patients who have a planned treatment with any other investigational device or procedure during the study period.
•6\.Patients planned to undergo any other cardiac surgical or interventional procedure during the TAVI procedure (e.g., concurrent coronary revascularization or within 10 days prior to the TAVI procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVI procedure.
•7\.Patients with contraindication to cerebral MRI