Clinical trial NCT02768402: Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study
Official title: Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Valve Regurgitation
Keywords: Mitral Valve Regurgitation
Primary MR
Secondary MR
MR
Heart Failure
Structural Heart
Secondary Mitral Valve Regurgitation
Primary Mitral Valve Regurgitation
Transseptal
Transcatheter
Lead sponsor: Caisson Interventional LLC
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 20
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 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.

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; transischemic 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: Intraoperative
measure: Number of living, stroke-free patients with prosthetic valve in place (device success)
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
city: Nashville
country: United States
facility: Saint Thomas Heart
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: NYU Langone Medical Center
name: Mathew Williams, MD
role: STUDY_DIRECTOR
References: