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NCT04473092 Clinical Trial

Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort

Mitral Regurgitation Clinical Trial

— OneForAll  

Official title:
Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04473092
Other study ID # 20-9223-BO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 20, 2020
Est. completion date September 30, 2022

Study information
Verified date November 2022
Source University Hospital, Essen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To identify changes on mitral valve morphology and functionality by the application of the PascalTM in MR.

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 information / eligibility
Status Completed
Enrollment 80
Est. completion date September 30, 2022
Est. primary completion date September 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: • All patients who undergo TVMR for MR (age >18yrs) at the PI´s site Exclusion Criteria: - <18yry - Subject does not provide full consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TMVR
Patients who undergo TMVR for MR at the PI´s site

Locations
Country Name City State
Germany University Hospital Essen, Westgerman Heart and Vascular Center, Department of Cardiology and Vascular Medicine Essen NRW

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Morphologic and functional changes of mitral valve anatomy 1 year
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