ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Mitral Regurgitation
- Sponsor
- Mitre Medical Corp.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Rate of Freedom from Major Adverse Events
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of Freedom from Major Adverse Events
Time Frame: Procedure through 30 days
Freedom from Major Adverse Events such as death, stroke, Increase of NYHA \>1, Re-Hospitalization or reoperation of the Mitral Valve
Secondary Outcomes
- Rate of Technical Feasibility to implant the Mitral Touch Device(Procedure)
- Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device(procedure)