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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01500148
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : January 22, 2014
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment Phase
Mitral Valve Prolapse Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr) Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept
Study Start Date : December 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intevention-PMVr Procedure Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.

Primary Outcome Measures :
  1. Device and Procedural Success [ Time Frame: During the investigational procedure ]

    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.

Secondary Outcome Measures :
  1. Quantification of SAEs reported that are unique to the investigational procedure [ Time Frame: Through 6 weeks post-implantation ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01500148

United Kingdom
Papworth Hospital
Cambridge, United Kingdom
Sponsors and Collaborators
St. Jude Medical

Responsible Party: St. Jude Medical Identifier: NCT01500148     History of Changes
Other Study ID Numbers: 1101
First Posted: December 28, 2011    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by St. Jude Medical:
Mitral Valve Prolapse
Mitral Valve Disease
Mitral Valve Regurgitation
Mitral Valve Insufficiency
Mitral Valve Incompetence
Percutaneous Mitral Valve Repair
Posterior leaflet prolapse
Mitral valve degeneration

Additional relevant MeSH terms:
Mitral Valve Prolapse
Pathological Conditions, Anatomical
Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases