Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System (TIARA-I)

January 7, 2022 updated by: Neovasc Inc.

Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who are at high risk for open chest surgery.

A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum of 15 subjects will be implanted in the United States.

Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a transcatheter mitral valve replacement (TMVR) procedure.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, B 2060
        • ZNA Middelheim
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Michigan
      • Detroit, Michigan, United States, 48188
        • Henry Ford Health System
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe symptomatic mitral regurgitation (Stage D)
  • High surgical risk for open mitral valve surgery
  • Subject meets the anatomical eligibility criteria for available size(s)
  • NYHA Class III or IV heart failure

Exclusion Criteria:

  • DMR deemed by the heart team to be operable.
  • Prohibitive risk, deemed too frail or listed for cardiac transplant.
  • Unsuitable cardiac structure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Device: Mitral valve replacement
Transcatheter mitral valve replacement
Other Names:
  • TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From All-cause Mortality and Major Adverse Events
Time Frame: From the time of implant procedure to 30 days or hospital discharge (whichever is later)
Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention
From the time of implant procedure to 30 days or hospital discharge (whichever is later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
Time Frame: 30 days, 90 days, 180 days and annually to five years
30 days, 90 days, 180 days and annually to five years
Individual 30 Day Rates of Device and Procedure Related Major Adverse Events
Time Frame: 30 days
  1. All mortality
  2. All stroke
  3. Residual MR > mild (1+)
  4. Life threatening bleeding
  5. Acute kidney injury Grade 3
  6. New pacemaker/LBBB
  7. Coronary occlusion/myocardial infarction
  8. Urgent/emergent surgery or reintervention
30 days
Number and Percentage of Subjects With Progression of Heart Failure
Time Frame: One year
Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation
One year
Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter
Time Frame: Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years
Mitral regurgitation < moderate (2+) Effective valve orifice area ≥ 1.5 cm2 as assessed by post-procedural echocardiogram Mitral Valve gradient < 5 mmHg No migration No fracture No endocarditis Stroke free No additional valve/access related interventional or surgical procedures
Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years
Performance
Time Frame: 30 days, 90 days, 180 days and annually for five years
Clinical performance as measured by NYHA Functional Class, 6MWT, and the KCCQ Hemodynamic performance as assessed by echocardiography: mean MV gradient, mitral regurgitation, effective orifice area of the MV, LV systolic and diastolic dimensions as well as volume Stroke free survival Original intended device in place No additional valve/access-related interventional or surgical procedures
30 days, 90 days, 180 days and annually for five years
Days Alive and Out of Hospital
Time Frame: At one year
Number of days alive and not hospitalized
At one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neovasc Inc.

Investigators

  • Study Chair: Anson Cheung, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

January 6, 2020

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimate)

October 28, 2014

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 047-CPT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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