RecruitingNCT06863883

Aortic Stenosis - Prognosis, Risk and Outcomes

Measuring Outcomes in Aortic STenosis Patients Undergoing AVR - Evaluation of Prognosis Regarding Short- and Long-term Results (MASTER)

Sponsor

Vastra Gotaland Region

Enrollment

300 participants

Start Date

Mar 4, 2025

Study Type

OBSERVATIONAL

Conditions

Aortic Stenosis Disease

Summary

The investigators will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital, which is the second largest TAVI hospital in Sweden. Eligible patients should have a clinical indication for aortic valve replacement with TAVI and have preprocedural clinical investigations with echocardiography (UCG) and CCT and provide written informed consent. UCG, electrocardiogram (ECG) and blood samples will be taken in addition to clinical status, NYHA-class and collection of outcome events the day before the procedure, 1±2 hours, 24 ±6hours and daily after the procedure until discharged from Sahlgrenska. Further follow-up will be scheduled day 14, 30, 180, 365 and yearly. Cardiac MRI will be performed before, at 14 days and at 180 days after TAVI. Brain MRI will be performed before and 24± hours after TAVI. Cardiac CT will be performed at 180 days after TAVI.

Eligibility

Inclusion Criteria2

Patient with clinical indication for aortic valve replacement and scheduled for TAVI
Patient willing and able to provide signed informed consent

Exclusion Criteria4

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
Estimated glomerular filtration rate <30 ml/kg/min (CT without contrast can be performed)

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