Functional Mitral Regurgitation, Ischemic Mitral Regurgitation
Conditions
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.
Interventions
DEVICEImplant an epicardial device to reshape the mitral valve annulus
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.
Sponsors
BSWRI Cardiac Imaging Core Lab (CICL)
Mitre Medical Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
prospective, single arm, un-blinded, multi-center early feasibility study
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Freedom from Major Adverse Events | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Technical Feasibility to implant the Mitral Touch Device | Procedure | Septal lateral diameter reduction of the mitral valve at implantation, Reduction in MR Grade by at least 1 grade from baseline |
| Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device | procedure | Implantation of the Mitral Touch Device without Serious Adverse Events |
Countries
United States
Contacts
Primary ContactJohn MacMahon
Backup ContactLaura A Minarsch
Outcome results
None listed