PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair

Mitral Regurgitation Clinical Trial

Official title:

PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair: A Prospective, Single-center, Open-label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05865938
• Other study ID #: PASCAL vs. MitralClip
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2023
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.

Description:

A prospective single-center, open-label study to evaluate the safety and effectiveness of transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System compared to using the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of our mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device. Treating physicians had no influence on scheduling or system selection. Follow-up examinations will be performed one month and one year after the procedure with assessment of echocardiographic and functional status based on the New York Heart Association (NYHA) grade. Patient characteristics, baseline data, and data related to the procedure were assessed using a registry, medical records and the procedure protocols. This study is a subproject of the MitraClip® Registry (NCT02033811)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years
• Severe Mitral Regurgitation (3+ to 4+)
• Symptom status: NYHA functional class = II
• Patients with FMR or DMR, who were referred for M-TEER by the heart team decision due to a high

Exclusion Criteria:

• Life expectancy < 1 year
• Anatomy of the mitral valve that may not be suitable for the MitraClip or PASCAL device
• Contraindication for transoesophageal echocardiography
• Active endocarditis
• Pregnant or planning pregnancy within next 12 months

Related Conditions & MeSH terms

• Functional Mitral Regurgitation
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• PASCAL vs. MitraClip
transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device.

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success	as defined by the Mitral Valve Academy Research Consortium (MVARC)	one month after implantation
Primary	Composite endpoint of all-cause death and heart failure hospitalization		one year after implantation
Secondary	Grade of Mitral Regurgitation	measured by echocardiography	one month and one year after implantation
Secondary	Functional status	according to New York Heart Association (NYHA) functional class	one month and one year after implantation