Caisson Transcatheter Mitral Valve Replacement (TMVR) (INTERLUDE)

Caisson Interventional

Status: Active, not recruiting

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

Treatments: Device: Transcatheter Mitral Valve Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT03661398

INT-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Transcatheter Mitral Valve Replacement

Experimental group

Description:

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

Treatment:

Device: Transcatheter Mitral Valve Replacement