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Recruiting NCT06168123

Future Optimal Research and Care Evaluation - Aortic Stenosis

— Observational Severe Aortic Valve Stenosis Moderate 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
The protocol lists: Quality of life questionnaires will be assessed in addition to standard care.
Who it may be relevant to
Registry conditions: Severe Aortic Valve Stenosis, Moderate Aortic Valve Stenosis. Basic parameters: 18 years — 110 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
Netherlands
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 →

Overview

In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Nowadays, it more and more becomes an alternative to surgical aortic valve replacement (SAVR) - also in younger and lower risk patients. This poses important questions to clinical practise regarding the optimal life-time management of each individual patient. Which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment. Objective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in AoS patients.

Interventions

  • Behavioral Quality of life questionnaires will be assessed in addition to standard care
    Quality of life questionnaires will be assessed in addition to standard care

Primary outcome measures

  • Quality of life as assessed by the EQ-5D-5L [Time frame: Until completion of the study (August 1, 2027)]
  • Quality of life as assessed by the KCCQ [Time frame: Until completion of the study (August 1, 2027)]
  • Quality of life as assessed by the SF-12 [Time frame: Until completion of the study (August 1, 2027)]
Secondary outcome measures (12)
  • Mortality according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • Neurological events according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • Hospitalisation according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • Bleeding and transfusions according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • Vascular and access-related complications according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • Cardiac structural complications according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • Other procedural or valve-related complications according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • New conduction disturbances and arrhythmias according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • Acute kidney injury according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • Myocardial infarction according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • Bioprosthetic valve dysfunction according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]
  • Leaflet thickening and reduced motion according the VARC-3 criteria [Time frame: Until completion of the study (August 1, 2027)]

Eligibility criteria

Inclusion criteria

  • Older than 18 years of age
  • Severe or moderate aortic stenosis

No exclusion criteria are applicable to this registry

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

Netherlands · 1 center
  • St. Antonius Hospital — Nieuwegein

Identifiers

NCT: NCT06168123 · Z23.069

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗