Status:
UNKNOWN
Epicardial Mitral Repair Trial - ENRAPT-MR
Lead Sponsor:
Mitre Medical Corp.
Collaborating Sponsors:
Meditrial Europe Ltd.
Medical Metrics Diagnostics, Inc
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03864848
Start Date
December 18 2017
End Date
December 20 2024
Last Update
January 18 2023
Active Locations (1)
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1
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania