Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).

Detailed Description
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The treatment guidelines for valvular heart disease indicate that surgical correction of primary mitral valve regurgitation (MR) is a Class I recommendation. Further, recent evidence indicates that valve replacement is at least as effective as repair in both primary and secondary MR patients. However, many patients are not referred for surgery as they are considered to be too high of a risk to undergo on pump, open-heart procedures. Percutaneous aortic valve replacement has made treatment of stenosed aortic valves available to high-risk surgical patients who would have otherwise been medically managed. Percutaneous mitral valve (MV) replacement offers similar advantages. Currently, the only approved percutaneous treatment for MR is MitraClip. MitraClip is limited to a specific population of high risk surgical patients with valvular prolapses that are amenable to repair by the edge to edge technique. The feasibility of percutaneous MV replacement has been shown in animal studies, the implantation of aortic valves at the mitral position, and early evaluations of purpose made transcatheter MVs in humans. To meet this medical need, Caisson Interventional has developed a percutaneous delivery system for a bioprosthetic mitral valve. As with patients with aortic valve (AV) deficiencies, this device can be used to provide needed therapy to patients who might not otherwise receive treatment beyond medical therapy. This study will provide initial information on the safety and performance of this system.

Official Title
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Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: Caisson TMVR System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has severe mitral regurgitation New York Heart Association (NYHA) Class II, III, IVa or heart failure High risk for cardiovascular surgery Exclusion Criteria: Excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass Left ventricular end diastolic dimension > 7cm Left ventricular outflow tract obstruction Severe right ventricular dysfunction Stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index procedure

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 Arm<br>All eligible patients will be in the treatment arm for the 'Caisson TMVR System' (transcatheter mitral valve replacement) procedure. No control or comparator in this study. | Device: Caisson TMVR System<br>* Transcatheter mitral valve replacement is a percutaneous procedure used to treat mitral valve regurgitation with a prosthetic valve implantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients without Major Adverse Events (MAEs) | Freedom from major adverse events including death, stroke, myocardial infarction and surgical reintervention through 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with successful delivery and implantation of the prosthetic valve (technical success) | Successful delivery and retrieval of the transcatheter mitral valve delivery system; deployment and correct positioning (via intraoperative imaging) in the appropriate anatomic location of prosthetic valve with no requirement for additional surgery | Intraoperative | 
| Number of living, stroke-free patients with prosthetic valve in place (device success) | Patient is alive, stroke-free, original intended device in place (echo), no mitral valve surgical re-intervention required | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MR, Mitral Valve Regurgitation, Primary MR, Secondary MR, Heart Failure, Structural Heart, Secondary Mitral Valve Regurgitation, Primary Mitral Valve Regurgitation, Transseptal, Transcatheter