Epicardial Mitral Repair Trial - ENRAPT-MR

Not Applicable

Recruiting

• Conditions: Mitral Regurgitation
• Interventions: Device: Mitral Touch Implant

• Registration Number: NCT03864848
• Lead Sponsor: Mitre Medical Corp.

Brief Summary

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)).

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 Timeline

• Study Start: 2017-12-18
• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 &lt; 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Mitral Touch Implant	Treatment with the Mitral Touch Implant for Epicardial Annuloplasty.

Primary Outcome Measures

Name	Time	Method
Safety - 30 - Day Major Adverse Event Rate	30-Days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vilnius University Hospital Santariskiu Klinikos; 🇱🇹 Vilnius, Lithuania