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

NCT ID: NCT02768402

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2023-12-31

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.

Conditions

Mitral Valve Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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.

Group Type: EXPERIMENTAL

Caisson TMVR System

Intervention Type: DEVICE

Transcatheter mitral valve replacement is a percutaneous procedure used to treat mitral valve regurgitation with a prosthetic valve implantation.

Interventions

Caisson TMVR System

Transcatheter mitral valve replacement is a percutaneous procedure used to treat mitral valve regurgitation with a prosthetic valve implantation.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Caisson Interventional LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathew Williams, MD

Role: STUDY_DIRECTOR

NYU Langone Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Delray Medical Center

Delray Beach, Florida, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, 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

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id