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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.
 
ClinicalTrials.gov Identifier: NCT02276547
Recruitment Status : Active, not recruiting
First Posted : October 28, 2014
Last Update Posted : September 29, 2020
Sponsor:
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)
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
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 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) ]

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 ]
  3. Number and percentage of subjects with progression of heart failure [ Time Frame: One year ]
  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 ]
  5. 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 ]
  6. Days alive and out of hospital [ Time Frame: At one year ]


Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT02276547


Locations
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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
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
Sponsors and Collaborators
Neovasc Inc.
Investigators
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Study Chair: Anson Cheung, MD University of British Columbia
Additional Information:
Publications:
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.
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
Keywords provided by Neovasc Inc.:
Mitral
Regurgitation
Heart valve
Transcatheter
Transapical
Functional
Degenerative
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