Predicting long-term outcomes for patients with aortic stenosis after valve intervention
Official title: Biological Valve Prosthesis in Aortic Stenosis - Imaging, Biomarkers, Physical Performance and Patient Related Factors Predictive to Long-term Outcome (Bio-AS)
Run by Uppsala University · NCT05629104 · Data updated 2026-11-12
This study is trying to see how well patients with severe aortic stenosis do after they have heart valve surgery or a procedure, by following their health over a few years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Uppsala University Academic / other |
| Locations | 1 site (Uppsala) |
| Status | Recruiting |
| Started | May 15, 2019 |
| Main results expected | December 2024 |
| Study ends | December 2027 |
| Registry record updated | November 29, 2022 |
| Trial ID | NCT05629104 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with severe aortic stenosis who are accepted for valve intervention.
✕Probably not a fit
Patients unable to follow the study protocol may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study includes patients with severe aortic stenosis who are scheduled for transcatheter intervention or open surgery. Participants are monitored through clinical visits during the first year post-intervention, with imaging assessments using echocardiography, CT, MRI, and PET-CT for a subgroup. Blood samples, physical performance metrics, and questionnaires focusing on frailty and heart failure are collected at each visit. Long-term outcomes will be tracked through national registries over a follow-up period of 2-5 years.
Why it matters
Potential benefit: If successful, this study could enhance understanding of long-term outcomes in patients undergoing valve interventions, potentially leading to improved patient management.
How similar studies have gone: While similar observational studies have been conducted, this specific approach to long-term outcome prediction in aortic stenosis is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Accepted for aortic valve intervention Exclusion Criteria: * No able to follow the study protocol
Where it's running
-
Department of cardiology Uppsala University Hospital
Uppsala, Sweden Recruiting
Study contacts
- Principal investigator: Christina Christersson, MD PhD — VO hjärt-lungmedicin och klinisk fysiologi Akademiska Sjukhuset
- Study coordinator: Christina Christersson, MD PhD
- Email: christina.christersson@medsci.uu.se
- Phone: +46186119068
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
-
Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
-
Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
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Echo-AVCS: Drawing AI-powered clues from heart scans to confirm severe aortic stenosis
This study tests an AI-based echocardiography score to help confirm severe aortic stenosis in adults who are also getting CT calcium scoring.
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TAVI without on-site heart surgery: can selected centers do it safely?
This trial tests whether transcatheter aortic valve implantation can be done safely in certain hospitals that don’t have on-site cardiac surgery, for patients with severe aortic stenosis who are appropriately selected.
-
Willem AI for early detection of aortic stenosis from a 12‑lead ECG
This project will test whether the Willem AI can detect aortic stenosis from routine 12‑lead ECGs in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.