Brief Title
Hamburg AoRtic Valve cOhoRt
Official Title
Clinical Cohort Study - Hamburg AoRtic Valve cOhoRt
Brief Summary
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.
Detailed Description
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.
Study Type
Observational [Patient Registry]
Primary Outcome
All cause mortality
Secondary Outcome
Myocardial Infarction
Condition
Aortic Valve Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
15000
Start Date
September 1, 2019
Completion Date
September 1, 2049
Primary Completion Date
September 1, 2039
Eligibility Criteria
Inclusion Criteria: - Patients with clinically relevant aortic valve disease (aortic valve stenosis, aortic regurgitation, degenerated aortic valve prosthesis) - Written informed consent Exclusion Criteria: - Insufficient knowledge of the German language (able to understand and write the German language) - Physical or psychological incapability to take part in the investigation
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Moritz Seiffert, MD, +49407410, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04227002
Organization ID
HARbOR
Responsible Party
Sponsor
Study Sponsor
Universitätsklinikum Hamburg-Eppendorf
Study Sponsor
Moritz Seiffert, MD, Principal Investigator, University Heart Center Hamburg
Verification Date
January 2020