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The primary aim of the study is to identify the optimal treatment modality for patients with aortic valve disease, incorporating the individual patient's risk profile and anticipated clinical outcomes. This includes the association of demographic factors, procedural data and biomarkers with clinical outcome in a prospective fashion.
Patients with severe aortic valve disease have a poor prognosis under medical therapy, making replacement of the failing valve the preferred option. In addition to surgical aortic valve replacement (SAVR), transcatheter aortic valve implantation (TAVI) has evolved as an alternative treatment option for patients at intermediate and high operative risk. Before expansion of TAVI to low-risk and younger patients can be recommended, several questions remain to be investigated, e.g. optimal patient selection, periprocedural complications and long-term durability. Therefore every patient with a relevant aortic valve disease (aortic stenosis, aortic regurgitation or degenerative aortic valve prosthesis) who meets the inclusion/exclusion criterias is planned to be involved in the study.
Predictors of outcome are yet to be defined in patients with aortic valve disease in order to improve risk prediction for the different treatment modalities (medical, SAVR, TAVI).
The primary aim of the study is to identify the optimal treatment modality for the individual patient, incorporating the individual patient's risk profile and anticipated clinical outcomes. This includes the association of demographic factors, procedural data and biomarkers with clinical outcome in a prospective fashion.
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| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | The primary aim of the study is to investigate all cause mortality after surgical aortic valve replacement or transcatheter aortic valve replacement. Events of death will be registered either from in-house information or telephone follow-up of the patient or the referring physician as part of clinical routine. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Infarction | Myocardial infarction based on a combination of clinical criteria, ecg changes indicative of new ischemia and a significant rise in cardiac biomarkers (peak value exceeding 15 x as the upper reference limit for troponin or 5 x for CK-MB) within the first 72 hours (periprocedural myocardial infarction) or 30 days (spontaneous myocardial infarction) after index procedure | 30 days after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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The medical condition being studied is aortic valve disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moriz Seiffert, MD | Contact | +49407410 | 58206 | m.seiffert@uke.de |
| Niklas Schofer, MD | Contact | +49407410 | 58206 | n.schofer@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Moritz Seiffert, MD | University Heart Center Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäres Herz- und Gefäßzentrum | Recruiting | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39537128 | Derived | Demal TJ, Arndt N, Bhadra OD, Ludwig S, Grundmann D, Voigtlaender-Buschmann L, Waldschmidt L, Hannen L, Blankenberg S, Kirchhof P, Conradi L, Reichenspurner H, Schofer N, Schaefer A. Predictors for Length of Stay after Surgical Aortic Valve Replacement. Thorac Cardiovasc Surg. 2026 Mar;74(2):106-113. doi: 10.1055/a-2466-7245. Epub 2024 Nov 13. | |
| 34156524 |
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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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| Stroke | Assessment of clinical disability using a modified Rankin Scale (mRS) within the first 30 days after index procedure | 30 days after procedure |
| Vascular complications and bleeding | Evaluation of overt bleeding or vascular complications after index procedure by drop in haemoglobin and transfusion of packed red blood cells | 30 days after procedure |
| Durability of the implanted aortic valve prosthesis | Evaluation of long time durability of the implanted aortic valve prosthesis by echocardiography in the yearly follow up. | 10 years |
| Westermann D, Ludwig S, Kalbacher D, Spink C, Linder M, Bhadra OD, Nikorowitsch J, Waldschmidt L, Demal T, Voigtlander L, Schaefer A, Seiffert M, Pecha S, Schofer N, Greenbaum AB, Reichenspurner H, Blankenberg S, Conradi L, Schirmer J. Prevention of coronary obstruction in patients at risk undergoing transcatheter aortic valve implantation: the Hamburg BASILICA experience. Clin Res Cardiol. 2021 Dec;110(12):1900-1911. doi: 10.1007/s00392-021-01881-4. Epub 2021 Jun 22. |
| D014694 |
| Ventricular Outflow Obstruction |