Mitral Disease, Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Failure, Valve Disease, Heart, Valve Heart Disease
Conditions
Keywords
Percutaneous mitral valve replacement, Trans-septal mitral valve replacement, Transcatheter mitral valve replacement, TMVR, Primary MR, Secondary MR, Structural Heart Disease, Heart Failure, Degenerative Mitral Valve Disease, Functional Mitral Valve Disease
Brief summary
The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).
Detailed description
The treatment guidelines for valvular heart disease indicate that surgical correction of primary mitral valve regurgitation (MR) is a Class I recommendation. 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. The feasibility of percutaneous MV replacement has been demonstrated in early feasibility studies. 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 information on the safety and performance of this system.
Interventions
All eligible patients will be in the treatment arm for treatment with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System. There is no control (comparator) arm for this study.
Sponsors
Caisson Interventional LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; transient ischemic attack or myocardial infarction within 30 days of the index procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients without Major Adverse Events (MAEs) | 30 days | Freedom from major adverse events including death, stroke, myocardial infarction and surgical reintervention through 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with successful delivery and implantation of the prosthetic valve (technical success) | Intra-operative | 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 |
| Number of living, stroke-free patients with prosthetic valve in place (device success) | 30 days | Patient is alive, stroke-free, original intended device in place (echo), no mitral valve surgical re-intervention required |
Countries
United States
Outcome results
None listed