Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System (TIARA-I)
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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. |
ClinicalTrials.gov Identifier: NCT02276547 |
Recruitment Status :
Active, not recruiting
First Posted : October 28, 2014
Last Update Posted : September 29, 2020
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Condition or disease | Intervention/treatment | Phase |
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Mitral Valve Regurgitation | Device: Mitral valve replacement | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 30 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
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Device: Mitral valve replacement
Transcatheter mitral valve replacement
Other Name: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System |
- Freedom from all-cause mortality and major adverse events defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention [ Time Frame: 30 days from the implant procedure or hospital discharge (whichever is later) ]
- 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 ]
- Individual 30 day rates of device and procedure related major adverse events [ Time Frame: 30 days ]
- Number and percentage of subjects with progression of heart failure [ Time Frame: 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 ]
- Performance measured by NYHA Functional Class, 6 Minute Walk Test and the Kansas City Cardiomyopathy Questionnaire comparing baseline to each time period [ Time Frame: 30 days, 90 days, 180 days and annually for five years ]
- Days alive and out of hospital [ Time Frame: At one year ]

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.
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

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 ClinicalTrials.gov identifier (NCT number): NCT02276547
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 | |
Belgium | |
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 |
Study Chair: | Anson Cheung, MD | University of British Columbia |
Publications:
Responsible Party: | Neovasc Inc. |
ClinicalTrials.gov Identifier: | NCT02276547 |
Other Study ID Numbers: |
047-CPT-001 |
First Posted: | October 28, 2014 Key Record Dates |
Last Update Posted: | September 29, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Mitral Regurgitation Heart valve Transcatheter |
Transapical Functional Degenerative Symptomatic, severe mitral valve regurgitation, high risk for open mitral valve surgery |
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |