TriGUARD 3 TransCranial Doppler (TCD) Ultrasound Study: A prospective, randomized, real-time evaluation of blood filtration with the TriGUARD 3 Embolic Protection Device Using TCD During Transcatheter Aortic Valve Implantation (TAVI).

Phase 2

Withdrawn

• Conditions: paralysis; Stroke; 10046973

• Registration Number: NL-OMON49111
• Lead Sponsor: Keystone Heart

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

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

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 who have closed temporal window(s).
8. Patients with scheduled valve-in-valve procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>* High-intensity transient signals detected by transcranial Doppler (TCD),<br /><br>during the procedure.</p><br>