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Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System

NCT02276547 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-05-20

Study results available
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Summary

The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

Conditions

  • Mitral Valve Regurgitation

Interventions

DEVICE

Mitral valve replacement

Transcatheter mitral valve replacement

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Anson Cheung, MD · University of British Columbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2020-01-06
Completion
2025-08-31

Countries

  • United States
  • Belgium
  • Canada

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 NCT02276547 on ClinicalTrials.gov