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

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

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.

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation; Functional Mitral Regurgitation; Degenerative Mitral Valve Regurgitation
• Intervention / Treatment: Device: PASCAL vs. MitraClip

Detailed 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)

• Study Type: Observational
• Enrollment (Actual): 214

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with severe symptomatic mitral regurgitation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PASCAL-Group; M-TEER using MitraClip	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.
MitraClip-Group; M-TEER using PASCAL	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	as defined by the Mitral Valve Academy Research Consortium (MVARC)	one month after implantation
Composite endpoint of all-cause death and heart failure hospitalization		one year after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade of Mitral Regurgitation	measured by echocardiography	one month and one year after implantation
Functional status	according to New York Heart Association (NYHA) functional class	one month and one year after implantation

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Malte Kelm, Prof., Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf; Principal Investigator: Patrick Horn, MD, Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf; Principal Investigator: Jafer Haschemi, MD, Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Mitral Regurgitation; Functional Mitral Regurgitation; Degenerative Mitral Valve Regurgitation; M-TEER; TEER
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: PASCAL vs. MitralClip

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No