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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01500148
First received: December 6, 2011
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Mitral Valve Prolapse
Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Device and Procedural Success [ Time Frame: During the investigational procedure ] [ Designated as safety issue: No ]

    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:
  • Quantification of SAEs reported that are unique to the investigational procedure [ Time Frame: Through 6 weeks post-implantation ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 2
Study Start Date: December 2011
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500148

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01500148     History of Changes
Other Study ID Numbers: 1101
Study First Received: December 6, 2011
Last Updated: January 20, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Neurocirculatory Asthenia
Orthostatic Intolerance
Prolapse
Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Anxiety Disorders
Mental Disorders
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 25, 2014