Future Optimal Research and Care Evaluation - Aortic Stenosis
- Conditions
- Severe Aortic Valve StenosisModerate Aortic Valve Stenosis
- Registration Number
- NCT06168123
- Lead Sponsor
- St. Antonius Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Older than 18 years of age
- Severe or moderate aortic stenosis
No exclusion criteria are applicable to this registry
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life as assessed by the EQ-5D-5L Until completion of the study (August 1, 2027) 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.
Quality of life as assessed by the SF-12 Until completion of the study (August 1, 2027) 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.
Quality of life as assessed by the KCCQ Until completion of the study (August 1, 2027) 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.
- Secondary Outcome Measures
Name Time Method Other procedural or valve-related complications according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Bioprosthetic valve dysfunction according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Mortality according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Bleeding and transfusions according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Vascular and access-related complications according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
New conduction disturbances and arrhythmias according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Neurological events according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Hospitalisation according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Cardiac structural complications according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Acute kidney injury according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Myocardial infarction according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Clinically significant valve thrombosis according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Leaflet thickening and reduced motion according the VARC-3 criteria Until completion of the study (August 1, 2027) The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Trial Locations
- Locations (1)
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands