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

This study is currently recruiting participants.
Verified December 2011 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01500148
First received: December 6, 2011
Last updated: December 28, 2011
Last verified: December 2011
History of Changes

December 6, 2011
December 28, 2011
December 2011
June 2012   (final data collection date for primary outcome measure)
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.
Device and Procedural Success [ Time Frame: During 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.
Complete list of historical versions of study NCT01500148 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
St. Jude Medical Percutaneous Mitral Valve Repair Study
Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept

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.

Subjects will be followed-up through 6 weeks post implantation.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mitral Valve Prolapse
Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.
Experimental: Intevention-PMVr Procedure
Intervention: Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
August 2012
June 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Elizabeth Schultz (651) 756-4067 eschultz@sjm.com
United Kingdom
 
NCT01500148
1101
No
St. Jude Medical
St. Jude Medical
Not Provided
Not Provided
St. Jude Medical
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP