Future Optimal Research and Care Evaluation - Aortic Stenosis

Study Overview
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Brief Summary
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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.

Official Title
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Future Optimal Research and Care Evaluation - Aortic Stenosis

Conditions
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Severe Aortic Valve Stenosis, Moderate Aortic Valve Stenosis

Intervention / Treatment
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* Behavioral: Quality of life questionnaires will be assessed in addition to standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years of age Severe or moderate aortic stenosis No exclusion criteria are applicable to this registry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Until completion of the study (August 1, 2027) | 
| 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. | Until completion of the study (August 1, 2027) | 
| 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. | Until completion of the study (August 1, 2027) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Neurological events according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Hospitalisation according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Bleeding and transfusions according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Vascular and access-related complications according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Cardiac structural complications according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Other procedural or valve-related complications according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| New conduction disturbances and arrhythmias according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Acute kidney injury according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Myocardial infarction according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Bioprosthetic valve dysfunction according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Leaflet thickening and reduced motion according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) | 
| Clinically significant valve thrombosis according the VARC-3 criteria | The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria. | Until completion of the study (August 1, 2027) |