NCT04473092

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	TMVR	Patients who undergo TMVR for MR at the PI´s site

Timeline

• Start date: 2020-07-20
• Primary completion: 2022-09-20
• Completion: 2022-09-30
• First posted: 2020-07-16
• Last updated: 2022-11-03

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study