St. Jude Medical Percutaneous Mitral Valve Repair Study

Mitral Valve Prolapse Clinical Trial

— SJM PMVr  

Official title:

Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500148
• Other study ID #: 1101
• Status: Completed
• Phase: Phase 1
• Start date: December 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Mitral Valve Prolapse
• Prolapse

Intervention

Device:
• PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device and Procedural Success	The primary objective is to evaluate the technical feasibility and acute device deployment characteristics of the SJM PMVr Device.; Technical feasibility and deployment characteristics will be defined as: The ability of the delivery system to access the mitral valve; The ability of the device to capture mitral valve (MV) leaflet tissue; Ability to plicate MV leaflet tissue; The clip is able to be deployed in MV leaflet tissue; The delivery system is able to be removed.	During the investigational procedure
Secondary	Quantification of SAEs reported that are unique to the investigational procedure	The secondary objective is to evaluate safety of the SJM PMVr device by summarizing SAEs unique to accessing the valve, placing the clip, and removing the delivery system.	Through 6 weeks post-implantation