Aortic Stenosis - Prognosis, Risk and Outcomes

Launched by VASTRA GOTALAND REGION · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Aortic Stenosis - Prognosis, Risk and Outcomes," aims to better understand the health outcomes of patients with aortic stenosis who are scheduled to undergo a procedure called Transcatheter Aortic Valve Implantation (TAVI) at Sahlgrenska University Hospital in Sweden. The study will include 300 patients who have been advised by their doctors to replace their aortic valve and are able to give their consent to participate. To qualify, participants should be able to provide informed consent and have no major health issues that would prevent them from undergoing MRI or CT scans.

If you join this trial, you will undergo several tests and evaluations before and after the TAVI procedure. These include heart ultrasounds, electrocardiograms, and blood tests, as well as scans at different points in time to monitor your recovery. You will be followed up with additional assessments at 14 days, 30 days, 6 months, and yearly after the procedure. It’s important to note that participation is voluntary, and you can withdraw at any time. The study hopes to gather valuable information that could improve care for future patients with aortic stenosis.

Gender

ALL

Eligibility 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)