Health TrialsbyHealthPanel

Epicardial Mitral Touch System for Mitral Insufficiency

ConditionsIschemic Mitral RegurgitationFunctional Mitral Regurgitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorMitre Medical Corp.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Implant an epicardial device to reshape the mitral valve annulus

    Device

    The implant 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Device ImplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Freedom from Major Adverse Events

Freedom from Major Adverse Events such as death, stroke, Increase of NYHA \>1, Re-Hospitalization or reoperation of the Mitral Valve

Time frame
Procedure through 30 days

Secondary outcomes

1

Rate of Technical Feasibility to implant the Mitral Touch Device

Septal lateral diameter reduction of the mitral valve at implantation, Reduction in MR Grade by at least 1 grade from baseline

Time frame
Procedure
2

Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device

Implantation of the Mitral Touch Device without Serious Adverse Events

Time frame
procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mitre Medical Corp.

Lead sponsor

BSWRI Cardiac Imaging Core Lab (CICL)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: