Clinical Trial: St. Jude Medical Percutaneous Mitral Valve Repair Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: Subjects will be followed-up through 6 weeks post implantation.
Sponsor: St. Jude Medical

Current Primary Outcome: 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.


Original Primary Outcome: Device and Procedural Success [ Time Frame: During 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.


Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: St. Jude Medical

Dates:
Date Received: December 6, 2011
Date Started: December 2011
Date Completion:
Last Updated: January 20, 2014
Last Verified: January 2014