Clinical trial NCT04227002: Hamburg AoRtic Valve cOhoRt
Official title: Clinical Cohort Study - Hamburg AoRtic Valve cOhoRt
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The medical condition being studied is aortic valve disease

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.

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

Primary outcomes:
measure: All cause mortality
timeFrame: one year
Secondary outcomes:
measure: Myocardial Infarction
timeFrame: 30 days after index procedure
measure: Stroke
timeFrame: 30 days after procedure
measure: Vascular complications and bleeding
timeFrame: 30 days after procedure
measure: Durability of the implanted aortic valve prosthesis
timeFrame: 10 years
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum
Study officials:
affiliation: University Heart Center Hamburg
name: Moritz Seiffert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.