Epicardial Mitral Touch System for Mitral Insufficiency

This study is testing a new device called the Mitral Touch System for people with moderate to severe mitral insufficiency (a leaky heart valve) due to ischemic or functional mitral regurgitation. This device is designed to reshape the mitral valve and the left side of the heart without needing open-heart surgery. Researchers want to see how safe and effective the Mitral Touch System is when implanted during other planned heart surgeries. To join, you must be at least 22 years old, have moderate or greater mitral regurgitation, and be scheduled for heart surgery. The main goal is to track any major problems within 30 days after the procedure. The study plans to enroll 10 participants, but its current status is unclear.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 30 days after the procedure to check for major adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Epicardial Mitral Touch System for Mitral Insufficiency

Not Yet Recruiting

NAAges 22+InterventionalDevice feasibility

Mitre Medical Corp.

~10 participants

Updated 2023-01-04 on ClinicalTrials.gov

What's tested:Implant an epicardial device to reshape the mitral valve annulus

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Rate of Freedom from Major Adverse Events

Measured over Procedure through 30 days

Conditions

Ischemic Mitral Regurgitation

Functional Mitral Regurgitation

Where it's being run

1 sites across 1 states

Texas1

Study leadership

Robert L Smith II, MD · PRINCIPAL_INVESTIGATOR · Baylor Scott and White Medical Center

Who to contact

John MacMahon

[email protected]

(408)-940-5587

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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

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.)

What this trial measures

Rate of Freedom from Major Adverse EventsProcedure through 30 days
Freedom from Major Adverse Events such as death, stroke, Increase of NYHA \>1, Re-Hospitalization or reoperation of the Mitral Valve

Trialytics