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NCT Number: NCT06634121

Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population

To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Mitral Valve Insufficiency Valvular Heart Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In the context of M-TEER, two different systems (MitraClip vs. PASCAL) are CE certified and clinically available. In the case of non-complex anatomy, both systems are comparable in terms of effectiveness. Whether this holds true in cases of complex or highly complex anatomy in an "Allcomer patient population" is currently unclear.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age equal or above 18 years
  • Written consent
  • Heart Team recommends M-TEER

Exclusion criteria

  • Mitral Stenosis (MV mean PG > 5 mmHg)
  • Cardiogenic shock or hemodynamic instability at the time of intervention
  • Active endocarditis
  • Participant in another interventional cardiology study

Treatment and study plan

Transcatheter mitral valve edge-to-edge repair (M-TEER)

Device

M-TEER is performed via a transfemoral venous approach. After puncture of the interatrial septum the mitral valve is repaired using either the PASCAL or MitraClip device.

Primary outcomes

  1. Postprocedural residual MR measured by 3D EROA

    Time frame: During the index procedure

    residual MR measured by 3D EROA as continuous parameter

Secondary outcomes

  1. Reduction in MR EROA

    Time frame: During the index procedure

    Reduction in MR EROA from baseline to postprocedural (relative and absolut value)

  2. Comparing EROA in complex vs. non-complex patients

    Time frame: During the index procedure

    Evaluation according to EROA reduction

  3. Postprocedural MV opening area

    Time frame: During the index procedure

    Postprocedural MV opening area (planimetric)

  4. Postprocedural MV inflow gradient

    Time frame: During the index procedure

    Mean pressure gradient and pressure halftime

  5. SLDA

    Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up

    Single Leaflet Device Attachment

  6. Conversion to surgery or re-imaging of the MV

    Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up

    Conversion to surgery (urgently or elective) or re-imaging of the MV

  7. Stratification by MR etiology

    Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up

    Primary vs. Secondary MR

  8. Combined endpoint of mortality, repeat MV intervention or HHF

    Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up

    Assessed at 30-days and 1-year

  9. Quality of Life

    Time frame: At 30-day follow-up and at 1-year follow-up

    Measured using the KCCQ Score

  10. Exertional dyspnea

    Time frame: At 30-day follow-up and at 1-year follow-up

    NYHA functional class

Study contacts

Contact information is provided by the study sponsor or research team.

Jörg Hausleiter, Prof. Dr.

CONTACT

[email protected]

+4989440072361

Ludwig Weckbach, PD Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Acronym: LEAFLET I

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

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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