Epicardial Mitral Repair Trial - ENRAPT-MR

Mitral Regurgitation Clinical Trial

— ENRAPT-MR  

Official title:

ENRAPT-MR Trial: Epicardial Mitral Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03864848
• Other study ID #: TPL-0001
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: December 20, 2024

Study information

• Verified date: January 2023
• Source: Mitre Medical Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santariskiu Klinikos	Vilnius

Sponsors (3)

Lead Sponsor	Collaborator
Mitre Medical Corp.	Medical Metrics Diagnostics, Inc, Meditrial Europe Ltd.

Country where clinical trial is conducted

Lithuania, 

References & Publications (3)

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. — View 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. — View 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):9 — View Citation

Outcome

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

External Links

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