Caisson Transcatheter Mitral Valve Replacement (TMVR)

NCT ID: NCT03661398

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-20
• Study Completion Date: 2025-08-31

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.

Conditions

Mitral Regurgitation; Mitral Valve Disease; Mitral Valve Failure; Mitral Disease; Valve Heart Disease; Valve Disease, Heart

Study Design

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

Study Groups

Transcatheter Mitral Valve Replacement

Patients with symptomatic mitral regurgitation (garde 3 or 4), determined to be a high risk for cardiovascular surgery, will be treated with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System

Group Type: EXPERIMENTAL

Transcatheter Mitral Valve Replacement

Intervention Type: DEVICE

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.

Interventions

Transcatheter Mitral Valve Replacement

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.

Intervention Type: DEVICE

Other Intervention Names

Caisson Transcatheter Mitral Valve Replacement (TMVR) 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

• 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

Mat Williams, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

Pennsylvania State University

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

INT-001

Identifier Type: -

Identifier Source: org_study_id