Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort
- Conditions
- Mitral Regurgitation
- Registration Number
- NCT04473092
- Lead Sponsor
- University Hospital, Essen
- Brief Summary
To identify changes on mitral valve morphology and functionality by the application of the PascalTM in MR.
- Detailed Description
Transcatheter mitral valve repair (TMVR) in mitral regurgitation (MR) is increasingly applied in patients on high surgical risk. Interventional mitral valve repair can be applied is routinely applied in primary and secondary mitral regurgitation. While the edge-to-edge technique has been the solely available technlology in the marked for the last years, the recently introduced PascalTM technology represents a novel concept and is characterized by a central spacer, wider paddles, and larger dimensions. Implications of implantation of the PascalTM device on the mitral valve morphology and functionality concerning potential changes on mitral regurgitation as well as changes on mitral valve orifice area are to date not fully understood. The current study will identify anatomical changes to optimize ideal patient selection and optimal treatment approaches of the PASCALTM device.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
• All patients who undergo TVMR for MR (age >18yrs) at the PI´s site
- <18yry
- Subject does not provide full consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Morphologic and functional changes of mitral valve anatomy 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Essen, Westgerman Heart and Vascular Center, Department of Cardiology and Vascular Medicine
🇩🇪Essen, NRW, Germany