Epicardial Mitral Repair Trial - ENRAPT-MR

NCT03864848 | Unknown FDA Device

• 1 other identifier: TPL-0001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)).

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Technical Success - MR Reduction

  30-Days, 6 Months, 12 Months

• Technical Success - Coaptation Length Increase

  30-Days, 6 Months, 12 Months

• Technical Success - Septa-Lateral Reduction

  Implantation, 6 Months, 12 Months

• Technical Success - Improvement in NYHA Classification

  6 & 12 Months

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with the Mitral Touch Implant for Epicardial Annuloplasty.

Device: Mitral Touch Implant

Interventions

Mitral Touch Implant DEVICE

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.

Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mitre Medical Corp.: lead
• Meditrial Europe Ltd.: collaborator
• Medical Metrics Diagnostics, Inc: collaborator

Study Sites (1)

Vilnius University Hospital Santariskiu Klinikos

Vilnius, Lithuania

RECRUITING

Related Publications (3)

• 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.

  PMID: 20137971 BACKGROUND

• 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.

  PMID: 22437273 BACKGROUND

• 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.

  PMID: 33436291 RESULT

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

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

Model Details: Registry

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: March 6, 2019
• Study Start: December 18, 2017
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)