Epicardial Mitral Touch System for Mitral Insufficiency (ENRAPTUS)

ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Mitral Regurgitation; Functional Mitral Regurgitation
• Intervention / Treatment: Device: Implant an epicardial device to reshape the mitral valve annulus

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John MacMahon; Phone Number: (408)-940-5587; Email: jmacmahon@mitremedical.com
• Study Contact Backup: Name: Laura A Minarsch; Phone Number: (949)2805700; Email: laura22@mmc-medical.com

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Scott and White
      • Principal Investigator: Robert L. Smith, MD
      • Contact: Robert L. Smith, MD; Phone Number: 469-814-3278; Email: robert.smith1@bswhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Implantation; To epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy) using an epicardial implant.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mitre Medical Corp.
• Collaborators: BSWRI Cardiac Imaging Core Lab (CICL)
• Investigators: Principal Investigator: Robert L Smith II, MD, Baylor Scott and White Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 10, 2023
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: TPL0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No