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Completed

NCT Number: NCT05865938

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

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Degenerative Mitral Valve Regurgitation Functional Mitral Regurgitation Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PASCAL vs. MitraClip

Device

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.

Primary outcomes

  1. Procedural success

    Time frame: one month after implantation

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

  2. Composite endpoint of all-cause death and heart failure hospitalization

    Time frame: one year after implantation

Secondary outcomes

  1. Grade of Mitral Regurgitation

    Time frame: one month and one year after implantation

    measured by echocardiography

  2. Functional status

    Time frame: one month and one year after implantation

    according to New York Heart Association (NYHA) functional class

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 19, 2023
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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