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Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)

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: NCT03039855
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Neovasc Inc.

Brief Summary:
To evaluate the safety and 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: TIARA valve and transapical delivery system Not Applicable

Detailed Description:
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)
Study Start Date : January 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2026

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




Primary Outcome Measures :
  1. Freedom from all-cause mortality [ Time Frame: 30 days ]
  2. Freedom from major adverse events [ Time Frame: 30 Days ]
  3. Reduction of Mitral Regurgitation to optimal or acceptable [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Freedom from all-cause mortality [ Time Frame: 90 days, 180 days, one year and annually to five years ]
  2. Freedom from major adverse events [ Time Frame: 90 days, 180 days, one year and annually to five years ]
  3. Technical success [ Time Frame: Day 0 ]
    Per MVARC criteria

  4. Procedural success [ Time Frame: 30 days ]
    Per MVARC criteria

  5. Device success [ Time Frame: Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years ]
    Per MVARC criteria

  6. NYHA Functional Class [ Time Frame: 30 days, 90 days, 180 days and once annually for five years ]
    Number of subjects with improved NYHA class

  7. 6 Minute Walk Test [ Time Frame: 30 days, 90 days, 180 days and once annually for five years ]
    Increase in distance (m) from baseline

  8. Kansas City Cardiomyopathy Questionnaire [ Time Frame: 30 days, 90 days, 180 days and once annually for five years ]
    Improvement in quality of life

  9. Hemodynamic performance [ Time Frame: 30 days, 90 days, 180 days and once annually for five years ]
    Assessed by echocardiography

  10. Patient success [ Time Frame: 1 year ]
    Per MVARC Criteria



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 mitral regurgitation
  • High surgical risk for open mitral valve surgery
  • Subject meets anatomical eligibility criteria

Exclusion Criteria:

  • Deemed too frail by objective frailty assessments
  • Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant
  • Unsuitable cardiac structure
  • Clinically significant untreated Coronary Artery Disease (CAD)
  • Subjects on chronic dialysis
  • Pregnant or planning pregnancy within next 12 months
  • Documented bleeding or coagulation disorders
  • Active infections requiring antibiotic therapy
  • Subjects with a life expectancy less than 12 months

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): NCT03039855


Locations
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Sponsors and Collaborators
Neovasc Inc.
Additional Information:
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Responsible Party: Neovasc Inc.
ClinicalTrials.gov Identifier: NCT03039855    
Other Study ID Numbers: 047-CPT-003
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Keywords provided by Neovasc Inc.:
Mitral
Regurgitation
Heart valve
Transcatheter
Transapical
Functional
Degenerative
TMVR
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases