Epicardial Mitral Touch System for Mitral Insufficiency

Functional Mitral Regurgitation Clinical Trial

— ENRAPTUS  

Official title:

ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04396379
• Other study ID #: TPL0002
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2023
• Source: Mitre Medical Corp.
• Contact: John MacMahon
• Phone: (408)-940-5587
• Email: jmacmahon[@]mitremedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2027
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Functional Mitral Regurgitation
• Ischemic Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• Implant 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.

Locations

Country	Name	City	State
United States	Baylor Scott and White	Plano	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Mitre Medical Corp.	BSWRI Cardiac Imaging Core Lab (CICL)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Freedom from Major Adverse Events	Freedom from Major Adverse Events such as death, stroke, Increase of NYHA >1, Re-Hospitalization or reoperation of the Mitral Valve	Procedure through 30 days
Secondary	Rate of Technical Feasibility to implant the Mitral Touch Device	Septal lateral diameter reduction of the mitral valve at implantation, Reduction in MR Grade by at least 1 grade from baseline	Procedure
Secondary	Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device	Implantation of the Mitral Touch Device without Serious Adverse Events	procedure