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)
- Conditions
- Preventie CVA/TIA bij TAVIparalysisStroke10046973
- Registration Number
- NL-OMON46441
- Lead Sponsor
- Keystone Heart
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method