Tiara™ Transcatheter Mitral Valve Replacement Study

Study Overview
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Brief Summary
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To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

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

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

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: TIARA valve and transapical delivery system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system | Device: TIARA valve and transapical delivery system<br>* Transcatheter mitral valve replacement<br>* Other names: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from all-cause mortality |  | 30 days | 
| Freedom from major adverse events |  | 30 Days | 
| Reduction of Mitral Regurgitation to optimal or acceptable |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from all-cause mortality |  | 90 days, 180 days, one year and annually to five years | 
| Freedom from major adverse events |  | 90 days, 180 days, one year and annually to five years | 
| Technical success | Per MVARC criteria | Day 0 | 
| Procedural success | Per MVARC criteria | 30 days | 
| Device success | Per MVARC criteria | Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years | 
| NYHA Functional Class | Number of subjects with improved NYHA class | 30 days, 90 days, 180 days and once annually for five years | 
| 6 Minute Walk Test | Increase in distance (m) from baseline | 30 days, 90 days, 180 days and once annually for five years | 
| Kansas City Cardiomyopathy Questionnaire | Improvement in quality of life | 30 days, 90 days, 180 days and once annually for five years | 
| Hemodynamic performance | Assessed by echocardiography | 30 days, 90 days, 180 days and once annually for five years | 
| Patient success | Per MVARC Criteria | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral, Regurgitation, Heart valve, Transcatheter, Transapical, Functional, Degenerative, TMVR