Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study
- Conditions
- Mitral Valve Regurgitation
- Interventions
- Device: Caisson TMVR System
- Registration Number
- NCT02768402
- Lead Sponsor
- Caisson Interventional LLC
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Has severe mitral regurgitation
- New York Heart Association (NYHA) Class II, III, IVa or heart failure
- High risk for cardiovascular surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm Caisson TMVR System 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of patients with successful delivery and implantation of the prosthetic valve (technical success) Intraoperative 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
Trial Locations
- Locations (13)
University of Washington
🇺🇸Seattle, Washington, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Delray Medical Center
🇺🇸Delray Beach, Florida, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
OhioHealth
🇺🇸Columbus, Ohio, United States
Saint Thomas Heart
🇺🇸Nashville, Tennessee, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Swedish Health Services
🇺🇸Seattle, Washington, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States