Heart Failure, Mitral Regurgitation, Valvular Heart Disease
Conditions
Keywords
Mitral Regurgitation, TEER, MitraClip, PASCAL
Brief 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.
Detailed description
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.
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.
Sponsors
LMU Klinikum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprocedural residual MR measured by 3D EROA | During the index procedure | residual MR measured by 3D EROA as continuous parameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exertional dyspnea | At 30-day follow-up and at 1-year follow-up | NYHA functional class |
| Postprocedural MV opening area | During the index procedure | Postprocedural MV opening area (planimetric) |
| Postprocedural MV inflow gradient | During the index procedure | Mean pressure gradient and pressure halftime |
| SLDA | During the index procedure, at 30-day follow-up and at 1-year follow-up | Single Leaflet Device Attachment |
| Quality of Life | At 30-day follow-up and at 1-year follow-up | Measured using the KCCQ Score |
| Stratification by MR etiology | During the index procedure, at 30-day follow-up and at 1-year follow-up | Primary vs. Secondary MR |
| Combined endpoint of mortality, repeat MV intervention or HHF | During the index procedure, at 30-day follow-up and at 1-year follow-up | Assessed at 30-days and 1-year |
| Reduction in MR EROA | During the index procedure | Reduction in MR EROA from baseline to postprocedural (relative and absolut value) |
| Comparing EROA in complex vs. non-complex patients | During the index procedure | Evaluation according to EROA reduction |
| Conversion to surgery or re-imaging of the MV | During the index procedure, at 30-day follow-up and at 1-year follow-up | Conversion to surgery (urgently or elective) or re-imaging of the MV |
Countries
Germany
Contacts
Primary ContactJörg Hausleiter, Prof. Dr.
Backup ContactLudwig Weckbach, PD Dr.
Outcome results
None listed