RecruitingNot ApplicableNCT06634121

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

Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population


Sponsor

LMU Klinikum

Enrollment

180 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two different types of devices — MitraClip and PASCAL — used in a procedure to repair a leaky heart valve (mitral regurgitation) without open-heart surgery. This is called transcatheter edge-to-edge repair (M-TEER). Both devices clip the two leaflets of the valve together to reduce leakage. The study aims to see which works better in a broad, real-world population of patients. **You may be eligible if...** - You are 18 or older - Your heart care team has recommended M-TEER for your leaky mitral valve - You can provide written informed consent **You may NOT be eligible if...** - You have mitral stenosis (a narrowed, stiff valve, rather than a leaky one) - You are in cardiogenic shock or hemodynamically unstable at the time of the procedure - You have active infection of the heart valves (endocarditis) - You are participating in another interventional heart study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

LMU Klinikum

Munich, Bavaria, Germany

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NCT06634121


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