Hamburg AoRtic Valve cOhoRt

  • STATUS
    Recruiting
  • End date
    Sep 1, 2049
  • participants needed
    15000
  • sponsor
    Universitätsklinikum Hamburg-Eppendorf
Updated on 19 February 2024
stenosis
regurgitation
aortic stenosis
aortic valve disease
disease, aortic

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.

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.

Details
Condition Aortic Stenosis, VALVULAR HEART DISEASE
Age 18years - 100years
Clinical Study IdentifierNCT04227002
SponsorUniversitätsklinikum Hamburg-Eppendorf
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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