Epicardial Mitral Repair Trial - ENRAPT-MR
Study Details
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)).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Treatment with the Mitral Touch Implant for Epicardial Annuloplasty. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Technical Success - MR Reduction [30-Days, 6 Months, 12 Months]
MR assessment of MR Grade by TTE compared to baseline
- Technical Success - Coaptation Length Increase [30-Days, 6 Months, 12 Months]
An increase of coaptation length compared to baseline
- Technical Success - Septa-Lateral Reduction [Implantation, 6 Months, 12 Months]
Target of 15%-30% Reduction when compared to baseline
- Technical Success - Improvement in NYHA Classification [6 & 12 Months]
Reduction in NYHA Classification compared to baseline
Eligibility Criteria
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
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Patient is willing and able to sign informed consent form
Exclusion Criteria:
-
History of endocarditis or current endocarditis
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Structural abnormalities of the leaflets and papillary muscles*
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Dysfunctional chordae*
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Any prior cardiac surgery including but not limited to CABG, Mitral Valve repair surgery, mechanical prosthetic Valve, or ventricular assist device, prior sternotomy*
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Ejection fraction <25%
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New York Hheart Association (NYHA) class IV
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MV diameters > 7cm
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Myxomatous Mitral regurgitation
-
Renal insufficiency (eGFR < 30 ml/min)
-
Severely calcified (posterior) Mitral Valve annulus
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Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)
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Any coronary artery calcification at site of placement as determined by angiogram.
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Abnormal cardiac anatomy discovered prior to surgery or during procedure.
-
Pericardial adhesions
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NOTE: Patients with prior or concurrent mitral chordae repair (example: PTFE or Neochord) are potential candidates for the MitralTouch
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vilnius University Hospital Santariskiu Klinikos | Vilnius | Lithuania |
Sponsors and Collaborators
- Mitre Medical Corp.
- Meditrial Europe Ltd.
- Medical Metrics Diagnostics, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- TPL-0001