Aortic stenosis prognosis and outcomes after TAVI
Official title: Measuring Outcomes in Aortic STenosis Patients Undergoing AVR - Evaluation of Prognosis Regarding Short- and Long-term Results (MASTER)
Run by Vastra Gotaland Region · NCT06863883 · Data updated 2026-11-12
This study tests how patients undergoing TAVI for aortic stenosis fare over time and how heart remodeling and brain imaging relate to outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 2 sites (Gothenburg and 1 other locations) |
| Status | Recruiting |
| Started | March 4, 2025 |
| Main results expected | December 2030 |
| Study ends | June 2031 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT06863883 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with an indication for TAVI and willing to undergo the scheduled imaging and follow-up assessments.
✕Probably not a fit
Patients unable to complete the imaging protocols or with contraindications to MRI/CT beyond allowed exclusions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study will enroll 300 patients planned for TAVI at Sahlgrenska University Hospital. It will collect clinical data, imaging (UCG, ECG, brain MRI, cardiac MRI, and CT), and blood tests before and after TAVI at specified intervals, plus quality-of-life measures. The goal is to describe prognosis, risk factors, and outcomes, including imaging markers of remodeling and microembolism. Follow-up includes visits up to one year and annually thereafter to track events and status.
Why it matters
Potential benefit: Participants may gain closer monitoring and contribute to knowledge that could improve future care for people undergoing TAVI.
How similar studies have gone: Prior studies using imaging biomarkers have shown associations with outcomes after TAVI, but this study’s comprehensive imaging approach is relatively novel in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with clinical indication for aortic valve replacement and scheduled for TAVI * Patient willing and able to provide signed informed consent Exclusion Criteria: * Inability to provide informed consent Additional exclusion criteria for MRI * Estimated glomerular filtration rate \<30 ml/kg/min (MRI without contrast can be performed ) * Claustrophobia or inability to tolerate confined spaces. * Non-compatible metal device present in body * Any other contra-indications for MRI as per local guidelines Additional exclusion criteria for the CT substudy * Estimated glomerular filtration rate \<30 ml/kg/min (CT without contrast can be performed)
Where it's running
-
Departement of Cardiology,
Gothenburg, Sweden Recruiting -
Departement of Cardiology
Gothenburg, Sweden Recruiting
Study contacts
- Study coordinator: Oskar Angerås, MD, PhD
- Email: oskar.angeras@vgregion.se
- Phone: +46 313421000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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TAVI and PCI vs SAVR and CABG in low- and intermediate-risk patients with severe aortic stenosis and CAD
This observational study compares TAVI plus PCI to SAVR plus CABG for patients who have both severe aortic stenosis and coronary artery disease.
-
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.
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This project will collect wearable physiologic data from adults with cardiovascular conditions to see how their heart disease changes over time.
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Finger photoacoustic arterial waveform monitoring for aortic valve disease and healthy adults
This project will test whether a finger-based photoacoustic device can capture arterial pulse waveforms and help identify aortic stenosis, aortic regurgitation, or normal heart function in adults.
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Optimized expansion of implanted transcatheter aortic valves to reduce leaflet thickening
This trial will test whether using systematic extra balloon dilatation before and after TAVI reduces leaflet thickening on CT in people with severe symptomatic aortic stenosis who are not on long‑term blood thinners.
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Which clinical and exercise-test measures predict better fitness after transcatheter aortic valve implantation (TAVI)
This study tries to see if clinical measures and cardiopulmonary exercise testing can predict which adults with severe aortic stenosis will have improved physical fitness after transfemoral TAVI.
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.