Epicardial Mitral Touch System for Mitral Insufficiency (ENRAPTUS)

Mitre Medical

Status: Not yet enrolling

Conditions: Ischemic Mitral Regurgitation; Functional Mitral Regurgitation

Treatments: Device: Implant an epicardial device to reshape the mitral valve annulus

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04396379

TPL0002

Details and patient eligibility

About

To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.

Full description

The Mitral Touch Systems is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.

Enrollment: 10 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate or greater (2+) ischemic
• Functional Mitral regurgitation by 2D echocardiography using an integrative method
• Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation)
• Patient is 22 years of age or older
• Patient is willing and able to sign Informed Consent Form
• Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States

Exclusion criteria

• Any evidence of structural (chordal or leaflet) mitral valve disease
• Inability to derive ERO, LVESVI or LVEDVI by TTE
• Prior surgical or percutaneous mitral valve intervention
• Contraindication to cardiopulmonary bypass (CPB)
• Clinical signs of cardiogenic shock
• Treatment with chronic intravenous inotropic therapy
• Severe, irreversible pulmonary hypertension in the judgement of the investigator
• ST segment elevation requiring intervention within 7 days prior to randomization
• Congenital heart disease (except PFO or ASD)
• Evidence of cirrhosis or hepatic synthetic failure
• Renal insufficiency (eGFR < 30 ml/min)
• History of endocarditis or current endocarditis
• Ejection fraction <25%
• NY heart class IV
• MV diameters > 7cm
• Any coronary artery calcification at site of placement as determined by angiogram
• Myxomatous mitral regurgitation
• Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)
• Abnormal cardiac anatomy discovered prior to surgery or during procedure
• Pericardial adhesions
• Insufficient clinical signature reduction of mitral regurgitation during device sizing and placement. (No device remains, patient moved to only 30-Day follow-up.)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Device Implantation

Experimental group

Description:

To epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy) using an epicardial implant.

Treatment:

Device: Implant an epicardial device to reshape the mitral valve annulus