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Feasibility Study of the transShield Embolic Protection System

NCT06652841 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-08-14

No results posted yet for this study

Summary

The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).

Conditions

  • Aortic Stenosis

Interventions

DEVICE

transShield Embolic Protection System

Patient undergoing TAVR procedure will receive the transShield EPS with the intent to capture and remove debris dislodged during the interventional procedure.

Sponsors & Collaborators

  • TransAortic Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2025-08-05
Completion
2025-08-05
FDA Device
Yes

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06652841 on ClinicalTrials.gov