Clinical trial NCT04396379: Epicardial Mitral Touch System for Mitral Insufficiency
Official title: ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Mitral Regurgitation
Functional Mitral Regurgitation
Lead sponsor: Mitre Medical Corp.
Sponsor class: INDUSTRY
Collaborators: name: BSWRI Cardiac Imaging Core Lab (CICL)
First posted: 2020-05-20
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, single arm, un-blinded, multi-center early feasibility study
Primary purpose: DEVICE_FEASIBILITY

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.

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.)

Primary outcomes:
measure: Rate of Freedom from Major Adverse Events
timeFrame: Procedure through 30 days
Secondary outcomes:
measure: Rate of Technical Feasibility to implant the Mitral Touch Device
timeFrame: Procedure
measure: Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device
timeFrame: procedure
Other outcomes:
Locations:
city: Plano
country: United States
facility: Baylor Scott and White
state: Texas
Study officials:
affiliation: Baylor Scott and White Medical Center
name: Robert L Smith II, MD
role: PRINCIPAL_INVESTIGATOR
References: