Epicardial Mitral Repair Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2024-12-20

Brief Summary

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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)).

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Detailed Description

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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.

Conditions

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Mitral Regurgitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Registry

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Treatment with the Mitral Touch Implant for Epicardial Annuloplasty.

Group Type EXPERIMENTAL

Mitral Touch Implant

Intervention Type DEVICE

The study population for this study will be comprised of patients who are to undergo cardiac surgery with a sternotomy (e.g. CABG) and who present moderate to severe ischemic or functional MR. In order to be considered eligible for the study, each patient must meet the conditions listed in the inclusion and none of the exclusion criteria.

Interventions

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Mitral Touch Implant

The study population for this study will be comprised of patients who are to undergo cardiac surgery with a sternotomy (e.g. CABG) and who present moderate to severe ischemic or functional MR. In order to be considered eligible for the study, each patient must meet the conditions listed in the inclusion and none of the exclusion criteria.

Intervention Type DEVICE

Eligibility Criteria

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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 \< 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No