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Recruiting NCT04227002

Hamburg AoRtic Valve cOhoRt

— Observational Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Cohort Study - Hamburg AoRtic Valve cOhoRt

Overview

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.

Primary outcome measures

  • All cause mortality [Time frame: one year]
Secondary outcome measures (4)
  • Myocardial Infarction [Time frame: 30 days after index procedure]
  • Stroke [Time frame: 30 days after procedure]
  • Vascular complications and bleeding [Time frame: 30 days after procedure]
  • Durability of the implanted aortic valve prosthesis [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Universitäres Herz- und Gefäßzentrum — Hamburg

Publications

  • 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. PMID 39537128
  • 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 D PMID 34156524

Identifiers

NCT: NCT04227002 · HARbOR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗