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.|
|ClinicalTrials.gov Identifier: NCT01500148|
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : January 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Mitral Valve Prolapse||Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01500148
|Cambridge, United Kingdom|