St. Jude Medical Percutaneous Mitral Valve Repair Study (SJM PMVr)

Abbott

Status and phase

Completed

Phase 1

Conditions

Mitral Valve Prolapse

Treatments

Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01500148

1101

Details and patient eligibility

About

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.

Full description

Subjects will be followed-up through 6 weeks post implantation.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).