St. Jude Medical Percutaneous Mitral Valve Repair Study

NCT ID: NCT01500148

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-08-31

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.

Conditions

Mitral Valve Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intevention-PMVr Procedure

Group Type: EXPERIMENTAL

PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)

Intervention Type: DEVICE

A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.

Interventions

PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)

A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Papworth Hospital

Cambridge, , United Kingdom

Countries

United Kingdom

Other Identifiers

1101

Identifier Type: -

Identifier Source: org_study_id