Status:
COMPLETED
St. Jude Medical Percutaneous Mitral Valve Repair Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Mitral Valve Prolapse
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
Detailed Description
Subjects will be followed-up through 6 weeks post implantation.
Eligibility Criteria
Inclusion
- Subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation.
- Subject has an ejection fraction (EF) ≥ 30%.
- Subject is of legal age (≥18 years old).
- Subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse.
Exclusion
- Subject requires a complex mitral valve repair or has isolated anterior prolapse.
- Subject has mitral valve stenosis in which the annulus opening is \<10mm. Subject has valve disease other than mitral which requires surgical intervention.
- Subject requires a concomitant procedure.
- Subject has a pre-existing prosthetic valve in any position.
- Subject had stenting or PCI within 6 months before the planned procedure, or is anticipated to require stenting or PCI within 6 months post-procedure.
- Subject has calcification of the mitral leaflets or annulus which in the medical opinion of the surgical investigator would limit repair and /or implantation of the investigational device.
- Subject has renal insufficiency or is on chronic dialysis.
- Subject has had a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
- Subject has a history of endocarditis or has active endocarditis.
- Subject has a history of autoimmune disease.
- Subject has significant known carotid artery disease.
- Subject has an aorto-mitral angle of \<110 degrees.
- Subject has hypertrophic obstructive cardiomyopathy (HOCM's Disease).
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01500148
Start Date
December 1 2011
End Date
August 1 2012
Last Update
February 4 2019
Active Locations (1)
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1
Papworth Hospital
Cambridge, United Kingdom