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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
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.
LMU Klinikum
Munich, Bavaria, Germany
RECRUITINGPostprocedural residual MR measured by 3D EROA
residual MR measured by 3D EROA as continuous parameter
Time frame: During the index procedure
Reduction in MR EROA
Reduction in MR EROA from baseline to postprocedural (relative and absolut value)
Time frame: During the index procedure
Comparing EROA in complex vs. non-complex patients
Evaluation according to EROA reduction
Time frame: During the index procedure
Postprocedural MV opening area
Postprocedural MV opening area (planimetric)
Time frame: During the index procedure
Postprocedural MV inflow gradient
Mean pressure gradient and pressure halftime
Time frame: During the index procedure
SLDA
Single Leaflet Device Attachment
Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up
Conversion to surgery or re-imaging of the MV
Conversion to surgery (urgently or elective) or re-imaging of the MV
Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up
Stratification by MR etiology
Primary vs. Secondary MR
Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up
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Combined endpoint of mortality, repeat MV intervention or HHF
Assessed at 30-days and 1-year
Time frame: During the index procedure, at 30-day follow-up and at 1-year follow-up
Quality of Life
Measured using the KCCQ Score
Time frame: At 30-day follow-up and at 1-year follow-up
Exertional dyspnea
NYHA functional class
Time frame: At 30-day follow-up and at 1-year follow-up