Epicardial Mitral Repair Trial - ENRAPT-MR (ENRAPT-MR)

ENRAPT-MR Trial: Epicardial Mitral Repair

Mitral Touch System

This device is designed to epicardially reshape the mitral valve annulus without the need for cardiopulmonary bypass (CPB) and open heart access (atriotomy), in patients with left ventricular dilation and ischemic or functional MR (mitral regurgitation (MR)).

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: Mitral Touch Implant

Detailed Description

Mitre Medical has developed an epicardial mitral annuloplasty device that can be implanted concomitant during planned coronary artery bypass surgery to help treat the MR patients. The Mitral Touch is designed to restore the S-L dimension and has the advantage of being placed without stopping the heart and placing the patient on a bypass pump.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania
    • Recruiting
    • Vilnius University Hospital Santariskiu Klinikos
    • Contact: Vilus Janusauskas, MD, PhD; Phone Number: +37061685712; Email: vilius.janusauskas@santa.lt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient has moderate (2+), moderate-to-severe (3+) or severe (4+) ischemic or functional Mitral regurgitation per 2D or 3D echocardiography, symptomatic or asymptomatic
• Patient is 18 years of age or older
• Patient is willing and able to sign informed consent form

Exclusion Criteria:

• History of endocarditis or current endocarditis
• Structural abnormalities of the leaflets and papillary muscles*
• Dysfunctional chordae*
• Any prior cardiac surgery including but not limited to CABG, Mitral Valve repair surgery, mechanical prosthetic Valve, or ventricular assist device, prior sternotomy*
• Ejection fraction <25%
• New York Hheart Association (NYHA) class IV
• MV diameters > 7cm
• Myxomatous Mitral regurgitation
• Renal insufficiency (eGFR < 30 ml/min)
• Severely calcified (posterior) Mitral Valve annulus
• Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)
• Any coronary artery calcification at site of placement as determined by angiogram.
• Abnormal cardiac anatomy discovered prior to surgery or during procedure.

• Pericardial adhesions

  • NOTE: Patients with prior or concurrent mitral chordae repair (example: PTFE or Neochord) are potential candidates for the MitralTouch

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Treatment; Treatment with the Mitral Touch Implant for Epicardial Annuloplasty.	Device: Mitral Touch Implant; The study population for this study will be comprised of patients who are to undergo cardiac surgery with a sternotomy (e.g. CABG) and who present moderate to severe ischemic or functional MR. In order to be considered eligible for the study, each patient must meet the conditions listed in the inclusion and none of the exclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - 30 - Day Major Adverse Event Rate	30 - Day Major Adverse Event Rate All-cause mortality Stroke Life-threatening bleeding (MVARC scale) Major vascular complications Major cardiac structural complications Stage 2 or 3 acute kidney injury (includes new dialysis) Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for >48 h Emergency surgery or re-intervention related to the device or access procedure	30-Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success - MR Reduction	MR assessment of MR Grade by TTE compared to baseline	30-Days, 6 Months, 12 Months
Technical Success - Coaptation Length Increase	An increase of coaptation length compared to baseline	30-Days, 6 Months, 12 Months
Technical Success - Septa-Lateral Reduction	Target of 15%-30% Reduction when compared to baseline	Implantation, 6 Months, 12 Months
Technical Success - Improvement in NYHA Classification	Reduction in NYHA Classification compared to baseline	6 & 12 Months

Collaborators and Investigators

• Sponsor: Mitre Medical Corp.
• Collaborators: Meditrial Europe Ltd.; Medical Metrics Diagnostics, Inc

Publications and helpful links

General Publications

• Takaseya T, Shiose A, Saraiva RM, Fumoto H, Arakawa Y, Juravic M, Lombardi P, Fukamachi K. Novel epicardial off-pump device for mitral regurgitation: acute evaluation. Eur J Cardiothorac Surg. 2010 Jun;37(6):1291-6. doi: 10.1016/j.ejcts.2009.11.054.
• Takaseya T, Fumoto H, Saraiva RM, Shiose A, Arakawa Y, Park M, Rao S, Dessoffy R, Kramer LD Jr, Juravic M, Lombardi P, Fukamachi K. Acute feasibility study of a novel device for the treatment of mitral regurgitation in a normal canine model. Innovations (Phila). 2010 Jan;5(1):28-32. doi: 10.1097/IMI.0b013e3181cdf735.
• Thourani VH, George I, Rucinskas K, Kalinauskas G, Janusauskas V, Zakarkaite D, Ailawadi G, Smith R, Mack MJ. First in human experience with an epicardial beating heart device for secondary mitral regurgitation. J Thorac Cardiovasc Surg. 2021 Mar;161(3):949-958.e4. doi: 10.1016/j.jtcvs.2020.11.169. Epub 2020 Dec 14.

Helpful Links

• RESULTS: First in human experience with an epicardial beating heart device for secondary mitral regurgitation

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Anticipated): December 20, 2024
• Study Completion (Anticipated): December 20, 2024

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 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: TPL-0001

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.: Yes