Aortic Stenosis - Prognosis, Risk and Outcomes

Recruiting now

Conditions studied: Aortic Stenosis Disease

In brief

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.

Key facts

Study ID

NCT06863883

Run by

Vastra Gotaland Region

People needed

300

Starts

2025-03-04

Expected to finish

2031-06-01

Last updated by the study team

2026-06-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 is running

• Departement of Cardiology, — Gothenburg, Sweden (enrolling)
• Departement of Cardiology — Gothenburg, Sweden (enrolling)

Full record on ClinicalTrials.gov

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