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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02276547
Recruitment Status : Active, not recruiting
First Posted : October 28, 2014
Results First Posted : May 25, 2021
Last Update Posted : January 18, 2022
Information provided by (Responsible Party):
Neovasc Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: Mitral valve replacement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System
Study Start Date : December 2014
Actual Primary Completion Date : January 6, 2020
Estimated Study Completion Date : February 2025

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 Name: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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 ]
  2. 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

  3. 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

  4. 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

  5. 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

  6. Days Alive and Out of Hospital [ Time Frame: At one year ]
    Number of days alive and not hospitalized

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02276547

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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48188
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
ZNA Middelheim
Antwerpen, Belgium, B 2060
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Neovasc Inc.
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Study Chair: Anson Cheung, MD University of British Columbia
  Study Documents (Full-Text)

Documents provided by Neovasc Inc.:
Additional Information:
Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. Review. Erratum in: J Thorac Cardiovasc Surg. 2014 Oct 21;64(16):1763. Dosage error in article text.

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Responsible Party: Neovasc Inc. Identifier: NCT02276547    
Other Study ID Numbers: 047-CPT-001
First Posted: October 28, 2014    Key Record Dates
Results First Posted: May 25, 2021
Last Update Posted: January 18, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Neovasc Inc.:
Heart valve
Symptomatic, severe mitral valve regurgitation, high risk for open mitral valve surgery
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases