Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: Mitral valve replacement


Participation Criteria
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Eligibility Criteria
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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

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: Mitral valve replacement<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 and Major Adverse Events | Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention | From the time of implant procedure to 30 days or hospital discharge (whichever is later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 30 days, 90 days, 180 days and annually to five years | 
| Individual 30 Day Rates of Device and Procedure Related Major Adverse Events | All mortality All stroke Residual MR > mild (1+) Life threatening bleeding Acute kidney injury Grade 3 New pacemaker/LBBB Coronary occlusion/myocardial infarction Urgent/emergent surgery or reintervention | 30 days | 
| Number and Percentage of Subjects With Progression of Heart Failure | Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation | One year | 
| Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter | 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 | Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years | 
| Performance | 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 | 30 days, 90 days, 180 days and annually for five years | 
| Days Alive and Out of Hospital | Number of days alive and not hospitalized | At one 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, Symptomatic, severe mitral valve regurgitation, high risk for open mitral valve surgery