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

Launched by LMU KLINIKUM · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different devices, MitraClip and PASCAL, used to repair a heart valve problem called mitral regurgitation. This condition means that the heart's mitral valve doesn't close properly, causing blood to flow backward and leading to symptoms like shortness of breath and fatigue. The goal of the study is to see if one device works better than the other in helping patients feel better and improving their heart function.

To participate in this trial, you need to be at least 18 years old and have a recommendation from a specialized heart care team for this type of valve repair. However, if you have a different heart problem like mitral stenosis, are in shock, or have a serious infection in your heart, you won't be eligible. If you join the study, you'll help researchers understand which device might be more effective, and you'll be closely monitored to ensure your safety and health throughout the process.

Gender

ALL

Eligibility criteria

• 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