TVMR With the Innovalve System Trial - First In Human Israel

Study Overview
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Brief Summary
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Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Detailed Description
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The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Official Title
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TVMR With the Innovalve System Trial - First In Human Israel

Conditions
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Mitral Valve Regurgitation (Degenerative or Functional)

Intervention / Treatment
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* Device: Innovalve MR system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically significant, symptomatic mitral regurgitation High risk for open-heart surgery Meets anatomical criteria Exclusion Criteria: Unsuitable anatomy Patient is inoperable EF<25%

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: Innovalve TMVR System<br>MV replacement with Innovalve MR system | Device: Innovalve MR system<br>* Innovalve MR system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of implant or delivery related serious adverse events at 30 days | Absence of implant or delivery related serious adverse events | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | All of the below: i. Absence of procedural mortality; and ii. Successful access, delivery, and retrieval of the device delivery system; and iii. Successful deployment and correct positioning of the first intended device; and iv. Freedom from emergency surgery or reintervention related to the device or access procedure. | Procedure | 
| Procedural success | All of the following must be present: I. Deployment of the device II. Absence of major device or procedure related serious adverse events, including: Death Stroke Life-threatening bleeding (MVARC scale) Major vascular complications Major cardiac structural complications Stage 2 or 3 acute kidney injury (includes new dialysis) Myocardial infarction or coronary ischemia requiring PCI or CABG Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for 48 h. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention | 30 days | 
| NYHA functional class |  | 30 days, 6, 12 months and annually up to 5 years | 
| Six-minute walk test |  | 30 days, 6, 12 months and annually up to 5 years | 
| Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire |  | 30 days, 6, 12 months and annually up to 5 years | 
| Reduction in Mitral Regurgitation grade |  | 30 days, 6, 12 months and annually up to 5 years |