Epicardial Mitral Touch System for Mitral Insufficiency

NCT04396379 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: TPL0002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Mitral Regurgitation; Functional Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of Technical Feasibility to implant the Mitral Touch Device

  Procedure

• Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device

  procedure

Study Arms (1)

Device Implantation

EXPERIMENTAL

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

Interventions

Implant an epicardial device to reshape the mitral valve annulus DEVICE

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.

Device Implantation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mitre Medical Corp.: lead
• BSWRI Cardiac Imaging Core Lab (CICL): collaborator

Study Sites (1)

Baylor Scott and White

Plano, Texas, 75093, United States

Location

Study Officials

• Robert L Smith II, MD

  Baylor Scott and White Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John MacMahon

CONTACT

(408)-940-5587; jmacmahon@mitremedical.com

Laura A Minarsch

CONTACT

(949)2805700; laura22@mmc-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, single arm, un-blinded, multi-center early feasibility study

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: September 10, 2023
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)