MedTrace Logo

transShield Embolic Protection System Feasibility Study

NCT04585308 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-11-22

No results posted yet for this study

Summary

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

Conditions

  • Aortic Stenosis

Interventions

DEVICE

transShield Embolic Protection System

Used for embolic protection during TAVR.

Sponsors & Collaborators

  • TransAortic Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Webster, MD · Auckland City Hospital

  • Carlos Calderas, MD · Policlinica Metropolitana - Venezuela

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2023-03-13
Completion
2023-03-13

Countries

  • New Zealand
  • Venezuela

Study Locations

More Related Trials

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 NCT04585308 on ClinicalTrials.gov