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

Heinrich-Heine University, Duesseldorf214 enrolled

Overview

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.

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)

Study Type

OBSERVATIONAL

Enrollment

214

Conditions

Mitral Regurgitation Functional Mitral Regurgitation Degenerative Mitral Valve Regurgitation

Interventions

PASCAL vs. MitraClipDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, Germany

Outcomes

Primary Outcomes

Procedural success

as defined by the Mitral Valve Academy Research Consortium (MVARC)

Time frame: one month after implantation

Composite endpoint of all-cause death and heart failure hospitalization

Time frame: one year after implantation

Secondary Outcomes

Grade of Mitral Regurgitation

measured by echocardiography

Time frame: one month and one year after implantation

Functional status

according to New York Heart Association (NYHA) functional class

Time frame: one month and one year after implantation

Data from ClinicalTrials.gov

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