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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitraClip | Active Comparator |
| |
| PASCAL | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter mitral valve edge-to-edge repair (M-TEER) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprocedural residual MR measured by 3D EROA | residual MR measured by 3D EROA as continuous parameter | During the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in MR EROA | Reduction in MR EROA from baseline to postprocedural (relative and absolut value) | During the index procedure |
| Comparing EROA in complex vs. non-complex patients | Evaluation according to EROA reduction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jörg Hausleiter, Prof. Dr. | Contact | +4989440072361 | Joerg.Hausleiter@med.uni-muenchen.de | |
| Ludwig Weckbach, PD Dr. | Contact | Ludwig.Weckbach@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Jörg Hausleiter, Prof. Dr. | LMU Klinikum | Principal Investigator |
| Ludwig Weckbach, PD Dr. | LMU Klinikum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMU Klinikum | Recruiting | Munich | Bavaria | 81377 | Germany |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| During the index procedure |
| Postprocedural MV opening area | Postprocedural MV opening area (planimetric) | During the index procedure |
| Postprocedural MV inflow gradient | Mean pressure gradient and pressure halftime | During the index procedure |
| SLDA | Single Leaflet Device Attachment | 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 | During the index procedure, at 30-day follow-up and at 1-year follow-up |
| Stratification by MR etiology | Primary vs. Secondary MR | During the index procedure, at 30-day follow-up and at 1-year follow-up |
| Combined endpoint of mortality, repeat MV intervention or HHF | Assessed at 30-days and 1-year | During the index procedure, at 30-day follow-up and at 1-year follow-up |
| Quality of Life | Measured using the KCCQ Score | At 30-day follow-up and at 1-year follow-up |
| Exertional dyspnea | NYHA functional class | At 30-day follow-up and at 1-year follow-up |