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

Primary Purpose

Mitral Regurgitation

Status

Recruiting

Phase

Not Applicable

Locations

Lithuania

Study Type

Interventional

Intervention

Mitral Touch Implant

About this trial

This is an interventional treatment trial for Mitral Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vilnius University Hospital Santariskiu KlinikosRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment with the Mitral Touch Implant for Epicardial Annuloplasty.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Technical Success - MR Reduction

MR assessment of MR Grade by TTE compared to baseline

Technical Success - Coaptation Length Increase

An increase of coaptation length compared to baseline

Technical Success - Septa-Lateral Reduction

Target of 15%-30% Reduction when compared to baseline

Technical Success - Improvement in NYHA Classification

Reduction in NYHA Classification compared to baseline

Full Information

NCT ID

NCT03864848

First Posted

November 1, 2018

Last Updated

January 17, 2023

Sponsor

Mitre Medical Corp.

Collaborators

Meditrial Europe Ltd., Medical Metrics Diagnostics, Inc

1. Study Identification

Unique Protocol Identification Number

NCT03864848

Brief Title

Epicardial Mitral Repair Trial - ENRAPT-MR

Acronym

ENRAPT-MR

Official Title

ENRAPT-MR Trial: Epicardial Mitral Repair

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 18, 2017 (Actual)

Primary Completion Date

December 20, 2024 (Anticipated)

Study Completion Date

December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitre Medical Corp.

Collaborators

Meditrial Europe Ltd., Medical Metrics Diagnostics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Regurgitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Registry

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Treatment with the Mitral Touch Implant for Epicardial Annuloplasty.

Intervention Type

Device

Intervention Name(s)

Mitral Touch Implant

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety - 30 - Day Major Adverse Event Rate

Description

Time Frame

30-Days

Secondary Outcome Measure Information:

Title

Technical Success - MR Reduction

Description

MR assessment of MR Grade by TTE compared to baseline

Time Frame

30-Days, 6 Months, 12 Months

Title

Technical Success - Coaptation Length Increase

Description

An increase of coaptation length compared to baseline

Time Frame

30-Days, 6 Months, 12 Months

Title

Technical Success - Septa-Lateral Reduction

Description

Target of 15%-30% Reduction when compared to baseline

Time Frame

Implantation, 6 Months, 12 Months

Title

Technical Success - Improvement in NYHA Classification

Description

Reduction in NYHA Classification compared to baseline

Time Frame

6 & 12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Vilnius University Hospital Santariskiu Klinikos

City

Vilnius

Country

Lithuania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vilus Janusauskas, MD, PhD

Phone

+37061685712

vilius.janusauskas@santa.lt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20137971

Citation

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.

Results Reference

background

PubMed Identifier

22437273

Citation

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.

Results Reference

background

PubMed Identifier

33436291

Citation

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.

Results Reference

result

Links:

URL

https://www.jtcvs.org/article/S0022-5223(20)33362-6/fulltext

Description

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

Learn more about this trial

Epicardial Mitral Repair Trial - ENRAPT-MR

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