Clinical trial NCT03661398: Caisson Transcatheter Mitral Valve Replacement (TMVR)
Official title: Clinical Investigation of the Caisson Transcatheter Mitral Valve Replacement (TMVR) System for Percutaneous Mitral Valve Replacement in Patients With Symptomatic Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Mitral Valve Disease
Mitral Valve Failure
Mitral Disease
Valve Heart Disease
Valve Disease, Heart
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
Lead sponsor: Caisson Interventional LLC
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients without Major Adverse Events (MAEs)
timeFrame: 30 days
Secondary outcomes:
measure: Number of patients with successful delivery and implantation of the prosthetic valve (technical success)
timeFrame: Intra-operative
measure: Number of living, stroke-free patients with prosthetic valve in place (device success)
timeFrame: 30 days
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: NYU Langone Medical Center
name: Mat Williams, M.D.
role: PRINCIPAL_INVESTIGATOR
References: