Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population
NCT06634121 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2024-10-09
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.
Conditions
- Mitral Regurgitation
- Valvular Heart Disease
- Heart Failure
Interventions
- DEVICE
-
Transcatheter 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.
Sponsors & Collaborators
-
LMU Klinikum
lead OTHER
Principal Investigators
-
Jörg Hausleiter, Prof. Dr. · LMU Klinikum
-
Ludwig Weckbach, PD Dr. · LMU Klinikum
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-01
- Primary Completion
- 2027-04-01
- Completion
- 2028-04-01
Countries
- Germany
Study Locations
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