Epicardial Mitral Touch System for Mitral Insufficiency

Launched by MITRE MEDICAL CORP. · May 15, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Mitral Touch System, which aims to help patients with a heart condition known as mitral insufficiency. This condition occurs when the heart's mitral valve doesn't close properly, leading to blood leaking backward into the heart. The trial will assess how safe and effective this device is for patients who are scheduled to have heart surgery, specifically those with moderate to severe cases of mitral regurgitation caused by issues like heart attacks or other heart problems.

To participate in the trial, patients must be at least 22 years old and scheduled for cardiac surgery, such as coronary artery bypass grafting (CABG) or heart transplantation. They should also have been on stable heart failure treatment for at least 90 days. However, there are specific criteria that would exclude some patients, such as those with severe heart valve damage or certain other health conditions. Participants will receive the treatment during their surgery and will be closely monitored for safety and effectiveness. This trial is not yet recruiting participants, so there is still time to learn more and see if this might be a suitable option.

Gender

ALL

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
• • 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.)