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 ]
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