Prediction of Long-term Outcome in Aortic Stenosis After Valve Intervention
Key facts
- Who runs it
- Uppsala University
- Where
- Sweden1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 300 people, planned
- Started
- 15 May 2019
- Expected to end
- Dec 2027
- Type of study
- Observational, 2 groups
- Treatments tested
- There is no intervention since it is an observational study patients are treated according to clinical praxis
- Record updated
- 29 November 2022
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Accepted for aortic valve intervention
Who cannot take part
- No able to follow the study protocol
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Preserved heart function
The group will be defined as preserved left ventricular ejection fraction (LVEF) with and without hypertrophy and with and without reduced global longitudinal strain (GLS).
Treatment: There is no intervention since it is an observational study patients are treated according to clinical praxis
- Reduced heart function
The group will be defined as reduced LVEF
Treatment: There is no intervention since it is an observational study patients are treated according to clinical praxis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Biological Valve Prosthesis in Aortic Stenosis - Imaging, Biomarkers, Physical Performance and Patient Related Factors Predictive to Long-term Outcome (Bio-AS)
- Record updated
- 29 November 2022