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
Inclusion Criteria3
- Age equal or above 18 years
- Written consent
- Heart Team recommends M-TEER
Exclusion Criteria4
- 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
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)
View Full Details on ClinicalTrials.gov
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NCT06634121
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