Clinical trial NCT03864848: Epicardial Mitral Repair Trial - ENRAPT-MR
Official title: ENRAPT-MR Trial: Epicardial Mitral Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Mitre Medical Corp.
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
name: Medical Metrics Diagnostics, Inc
First posted: 2019-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Registry
Primary purpose: TREATMENT

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.

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 \&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

Primary outcomes:
measure: Safety - 30 - Day Major Adverse Event Rate
timeFrame: 30-Days
Secondary outcomes:
measure: Technical Success - MR Reduction
timeFrame: 30-Days, 6 Months, 12 Months
measure: Technical Success - Coaptation Length Increase
timeFrame: 30-Days, 6 Months, 12 Months
measure: Technical Success - Septa-Lateral Reduction
timeFrame: Implantation, 6 Months, 12 Months
measure: Technical Success - Improvement in NYHA Classification
timeFrame: 6 & 12 Months
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
Study officials:
References:
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.
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.
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.