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| Name | Class |
|---|---|
| University Hopsital Schleswig Holstein Campus Lübeck | OTHER |
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Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transaxillary (TAX) transcatheter aortic valve replacement | Other | Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR). |
| Measure | Description | Time Frame |
|---|---|---|
| Time until first occurrence |
| 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who were treated with Myval TAVR via TAX access are included in the registry.
The participating centers also provide a retrospective cohort of TAX-TAVR implantations with other TAVR prothesis (e.g. Edwards Sapien XT/3/Ultra, Medtronic Evolut R/Pro, Accurate Neo, Allegra, Portico) to compare the results and outcomes of the MYVAL-TAX-TAVR registry using the Myval THV with other TAVR bioprothesis used for TAX-TAVR. To further improve comparability between groups propensity score matching between the groups will be performed using the following parameters (age, sex, STS score, peripheral artery disease, atrial fibrillation, minimum axillary diameter, moderate/severe axillary tortuosity and moderate/severe axillary, calcification).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingo Eitel, Prof. Dr. | Contact | +49451500444501 | ingo.eitel@uksh.de | |
| Roza Saraei, Dr. | Contact | +4945150044542 | roza.saraei@uksh.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität zu Lübeck | Recruiting | Lübeck | Schleswig-Holstein | 23538 | Germany |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013660 | Taxes |
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
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| D014694 |
| Ventricular Outflow Obstruction |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |