Severe aortic valve stenosis
Conditions
Interventions
Group 1: Cohort 1:
Analysis of the pre-procedural care pathway:
Assessment of time intervals along the diagnostic and therapeutic pathway in patients presenting to our center for TAVI with known aorti
expected patient recruitment: n=1000). Prospective recruitment of patients at the DHZC presenting with known severe aortic valve stenosis for an elective TAVI procedure. Data collection will be perfor
Sponsors
Deutsches Herzzentrum der Charité
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Cohort 1: Minimum age of 18 years Ability to provide informed consent Planned transcatheter aortic valve implantation (TAVI) Severe aortic valve stenosis No valve-in-valve procedures Cohort 2: Age >70 years Asymptomatic Residence in Berlin Ability to provide informed consent No previously diagnosed aortic valve stenosis
Exclusion criteria
Exclusion criteria: Cohort 1: Age <18 years Unable to provide informed consent Valve-in-valve procedures Cohort 2: Age <70 years Presence of cardiac symptoms Residence outside Berlin Unable to provide informed consent Previously diagnosed aortic valve stenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: Descriptive assessment of the experiences of patients presenting to our center (DHZC) for TAVI treatment due to known aortic valve stenosis over a 12-month period (01 July 2026 to 30 June 2027). Collected variables: Age, sex, comorbidities, living situation, referral source, transportation barriers, educational level, residential district, pre-existing medical conditions, previous healthcare contacts, etc. Primary endpoints: Time intervals between: Symptom onset First contact with a healthcare provider (HCP) First consultation with a cardiologist Date of echocardiography Date of coronary angiography Date of TAVI-CT Date of Heart Team discussion TAVI or surgical valve replacement (SAVR/AVR) Proportion of patients exceeding predefined time thresholds: 3 months between first HCP contact and echocardiography 6 weeks between Heart Team discussion and TAVI 4 months overall between diagnosis and valve replacement Data will be collected using the hospital information system (HIS) and questionnaires. Cohort 2: With a planned sample size of n = 2,000 asymptomatic Berlin residents and an expected prevalence of severe aortic stenosis of 3%, approximately 60 cases are anticipated. With this sample size, the prevalence estimate would be associated with a 95% confidence interval of approximately ±0.75%. Endpoints: Prevalence of previously undetected moderate-to-severe aortic valve stenosis (regardless of symptoms). Number needed to screen per newly diagnosed case. Proportion of patients successfully referred to specialized care pathways. Data will be collected through echocardiographic examinations and questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: Proportion of patients exceeding predefined time thresholds: 3 months between first contact with a healthcare provider (HCP) and echocardiography 6 weeks between Heart Team discussion and TAVI 4 months overall between diagnosis and valve replacement Cohort 2: Number needed to screen per newly diagnosed case Proportion of patients successfully referred to specialized care pathways | — |
Countries
Germany
Contacts
Public ContactHenryk Dreger
Deutsches Herzzentrum der Charité
Outcome results
None listed