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Recruiting NCT05629104

Prediction of Long-term Outcome in Aortic Stenosis After Valve Intervention

Observational Aortic 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
The protocol lists: There is no intervention since it is an observational study patients are treated according to clinical praxis.
Who it may be relevant to
Registry conditions: Aortic 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
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Biological Valve Prosthesis in Aortic Stenosis - Imaging, Biomarkers, Physical Performance and Patient Related Factors Predictive to Long-term Outcome (Bio-AS)

Overview

Patients with severe aortic stenosis accepted for transcatheter intervention or open surgery are included before the intervention, and then followed up with clinical visits during the first year after intervention. Imaging with echocardiography and computed tomography (CT) are performed together with additional imaging with magnetic resonance imaging (MRI) and Positron emissions tomography (PET)-CT in a subgroup of the study population. Blood samples, physical performance and questionnaires with focus on frailty and heart failure are also collected at each visit. A follow up with information of the outcomes after 2-5 years will be performed through national registries.

Interventions

  • Other There is no intervention since it is an observational study patients are treated according to clinical praxis
    No intervention

Primary outcome measures

  • Semiquantitative assessment of protein levels associated with myocardial performance [Time frame: One year after intervention.]
  • Imaging parameters associated with clinical outcome after intervention [Time frame: One year after intervention]
  • Semiquantitative assessment of protein levels associated with myocardial performance associated with clinical outcome after intervention [Time frame: Two years after intervention]
Secondary outcome measures (1)
  • Imaging parameters associated with clinical outcome after intervention [Time frame: Two years after intervention]

Eligibility criteria

Inclusion criteria

  • Accepted for aortic valve intervention

Exclusion criteria

  • No able to follow the study protocol

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

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Department of cardiology Uppsala University Hospital — Uppsala

Identifiers

NCT: NCT05629104 · Bio-AS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗