Clinical trial Recruiting at 2 sites Observational

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 typeObservational
SexAll
Enrollment300 (estimated)
SponsorVastra Gotaland Region
Government
Locations2 sites (Gothenburg and 1 other locations)
StatusRecruiting
StartedMarch 4, 2025
Main results expectedDecember 2030
Study endsJune 2031
Registry record updatedJune 2, 2026
Trial IDNCT06863883 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.