NCT04659538

The CAPTIS® Study - Embolic Protection in TAVR

A Prospective, Single Arm, FIH Study to Evaluate the Safety and Feasibility of the CAPTIS Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Filterlex Medical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	CAPTIS Embolic Protection device	The CAPTIS Embolic Protection device will be deployed during standard of care TAVR procedure. The device's safety will be assessed up to one month post procedure. The device's technical performance and feasibility to capture and remove debris during the procedure will be evaluated.

Timeline

• Start date: 2020-11-24
• Primary completion: 2022-05-03
• Completion: 2022-05-03
• First posted: 2020-12-09
• Last updated: 2022-05-25

Locations

3 sites across 1 country: Israel