Predicting long-term outcomes for patients with aortic stenosis after valve intervention
Biological Valve Prosthesis in Aortic Stenosis - Imaging, Biomarkers, Physical Performance and Patient Related Factors Predictive to Long-term Outcome (Bio-AS)
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Locations | 1 site (Uppsala) |
| Trial ID | NCT05629104 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with severe aortic stenosis who are accepted for valve intervention.
Not a fit: Patients unable to follow the study protocol may not benefit from this study.
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 performed: While similar observational studies have been conducted, this specific approach to long-term outcome prediction in aortic stenosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Accepted for aortic valve intervention Exclusion Criteria: * No able to follow the study protocol
Where this trial is running
Uppsala
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.