Universitäres Herz- und Gefäßzentrum
Hamburg, 20246, Germany
Location status: Recruiting
NCT Number: NCT04227002
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hamburg, 20246, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: one year
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.
Time frame: 30 days after index procedure
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
Time frame: 30 days after procedure
Assessment of clinical disability using a modified Rankin Scale (mRS) within the first 30 days after index procedure
Time frame: 30 days after procedure
Evaluation of overt bleeding or vascular complications after index procedure by drop in haemoglobin and transfusion of packed red blood cells
Time frame: 10 years
Evaluation of long time durability of the implanted aortic valve prosthesis by echocardiography in the yearly follow up.
Contact information is provided by the study sponsor or research team.
Universitätsklinikum Hamburg-Eppendorf
Other
Clinical Cohort Study - Hamburg AoRtic Valve cOhoRt
Acronym: HARbOR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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