Epicardial Mitral Repair Trial - ENRAPT-MR

Mitre Medical

Status: Enrolling

Conditions: Mitral Regurgitation

Treatments: Device: Mitral Touch Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03864848

TPL-0001

Details and patient eligibility

About

Mitral Touch System

This device is designed to epicardially reshape the mitral valve annulus without the need for cardiopulmonary bypass (CPB) and open heart access (atriotomy), in patients with left ventricular dilation and ischemic or functional MR (mitral regurgitation (MR)).

Full description

Mitre Medical has developed an epicardial mitral annuloplasty device that can be implanted concomitant during planned coronary artery bypass surgery to help treat the MR patients. The Mitral Touch is designed to restore the S-L dimension and has the advantage of being placed without stopping the heart and placing the patient on a bypass pump.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has moderate (2+), moderate-to-severe (3+) or severe (4+) ischemic or functional Mitral regurgitation per 2D or 3D echocardiography, symptomatic or asymptomatic
• Patient is 18 years of age or older
• Patient is willing and able to sign informed consent form

Exclusion criteria

• History of endocarditis or current endocarditis

• Structural abnormalities of the leaflets and papillary muscles*

• Dysfunctional chordae*

• Any prior cardiac surgery including but not limited to CABG, Mitral Valve repair surgery, mechanical prosthetic Valve, or ventricular assist device, prior sternotomy*

• Ejection fraction <25%

• New York Hheart Association (NYHA) class IV

• MV diameters > 7cm

• Myxomatous Mitral regurgitation

• Renal insufficiency (eGFR &lt; 30 ml/min)

• Severely calcified (posterior) Mitral Valve annulus

• Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)

• Any coronary artery calcification at site of placement as determined by angiogram.

• Abnormal cardiac anatomy discovered prior to surgery or during procedure.

• Pericardial adhesions

  • NOTE: Patients with prior or concurrent mitral chordae repair (example: PTFE or Neochord) are potential candidates for the MitralTouch

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment

Experimental group

Description:

Treatment with the Mitral Touch Implant for Epicardial Annuloplasty.

Treatment:

Device: Mitral Touch Implant