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Study of Outcomes and Prognosis in Patients Undergoing Transcatheter Aortic Valve Implantation TAVI for Aortic Stenosis Including Heart Imaging and Blood Sample Analysis Before and After Treatment
Led by Vastra Gotaland Region · Updated on 2026-06-02
300
Participants Needed
2
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are enrolling 300 patients undergoing transcatheter aortic valve implantation TAVI at a major hospital to study outcomes related to aortic stenosis disease. The study focuses on evaluating the prognosis, risks, and short- and long-term results associated with aortic valve replacement using TAVI. Key clinical assessments include echocardiography, cardiac CT, and various imaging methods to monitor heart function and brain health. Patients will have standard clinical imaging studies including ultrasound cardiogram UCG, cardiac CT, and electrocardiogram ECG before the procedure. Additional cardiac MRI scans will be done before, 14 days after, and 180 days after TAVI to assess heart remodeling and blood flow. Brain MRI will be performed before and shortly after TAVI to detect possible micro-embolism or stroke. Blood samples are collected at multiple time points for future biomarker analysis. Participants will be monitored through clinical status checks, NYHA classification, and collection of outcome events at multiple times the day before TAVI, several times within 24 hours after the procedure, daily until discharge, and follow-ups at days 14, 30, 180, 365, and yearly thereafter. Quality of life questionnaires are also completed at baseline and scheduled follow-ups. The primary outcome measures focus on cardiac damage at baseline and 180 days, with secondary measures including changes in echocardiography and cardiac MRI parameters.
CONDITIONS
Brief Title
Aortic Stenosis - Prognosis, Risk and Outcomes
Research Team
O
Oskar Angerås, MD, PhD
B
Björn Redfors, MD, PhD, Professor
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