Other Clinical Trial - The CAPTIS® Study - Embolic Protection in TAVR

Status Completed

Clinical Trial Summary

This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR)

Clinical Trial Description

This is a prospective, multi center, single arm, FIH safety and feasibility study enrolling up to 20 patients. Patients undergoing clinically indicated TAVR who comply with the study inclusion/exclusion criteria will be enrolled to have embolic protection with the CAPTIS® Device during the TAVR procedure. Screening activities will include initial screening by the site, analysis of patient CT scan by the sponsor and core-lab, and review of the clinical and imaging data by an eligibility committee to confirm that all inclusion/exclusion criteria are met. Final eligibility for study enrollment is then determined by the investigator in the cardiac catheterization laboratory. Enrolled patients will undergo safety assessment during the procedure, post-procedure, and at 30 days post-procedure; Feasibility evaluation will be assessed during procedure. ;

Study Design

Related Conditions & MeSH terms

Transcatheter Aortic Valve Replacement

Clinical Trial Details

NCT number	NCT04659538
Study type	Interventional
Source	Filterlex Medical Ltd.
Contact
Status	Completed
Phase	N/A
Start date	November 24, 2020
Completion date	May 3, 2022

View Details

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