Future Optimal Research and Care Evaluation - Aortic Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorSt. Antonius Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older than 18 years of age
Severe or moderate aortic stenosis
Disqualifiers
None
Trial population
Severe or moderate aortic stenosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Quality of life questionnaires will be assessed in addition to standard care
BehavioralQuality of life questionnaires will be assessed in addition to standard care
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Quality of life as assessed by the EQ-5D-5L
The EQ-5D-5L is a standardized health-related quality of life instrument that assesses individuals across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It generates a health profile that can be converted into a single index value, commonly ranging from -0.594 to 1, where 1 represents full health, 0 indicates a state equivalent to death, and negative values reflect health states perceived as worse than death.
Time frame
Until completion of the study (August 1, 2027)2
Quality of life as assessed by the KCCQ
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific instrument assessing heart failure patients across domains such as Total Symptoms, Physical Limitation, and Quality of Life, with scores ranging from 0 to 100. Higher scores indicate better health-related quality of life, while lower scores suggest increased symptomatology and functional limitations in heart failure patients.
Time frame
Until completion of the study (August 1, 2027)3
Quality of life as assessed by the SF-12
The Short Form 12 (SF-12) is a widely used health survey that measures health-related quality of life across physical and mental domains. It generates two summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), both ranging from 0 to 100, where higher scores indicate better health status, and these summaries provide a concise assessment of an individual's overall physical and mental well-being.
Time frame
Until completion of the study (August 1, 2027)Secondary outcomes
1
Mortality according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame
Until completion of the study (August 1, 2027)2
Neurological events according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame
Until completion of the study (August 1, 2027)3
Hospitalisation according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame
Until completion of the study (August 1, 2027)4
Bleeding and transfusions according the VARC-3 criteria
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame
Until completion of the study (August 1, 2027)Sponsors and contacts
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Source ClinicalTrials.gov