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

NCT ID: NCT04473092

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2022-09-30

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.

Conditions

Mitral Regurgitation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

TMVR

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Peter Lüdike

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Lüdike, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Essen, Westgerman Heart- and Vascular Center, Department of Cardiology and Vascular Medicine

Locations

University Hospital Essen, Westgerman Heart and Vascular Center, Department of Cardiology and Vascular Medicine

Essen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

20-9223-BO

Identifier Type: -

Identifier Source: org_study_id