Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement

Who can take part

Inclusion Criteria: Subjects are eligible to be included in the trial only if all of the following criteria apply: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * Adults (≥18 years) undergoing TAVR for severe AS, and * BMI ≥30 kg/m2, or * BMI 27-30 kg/m2, AND at least one of the following: * Dysglycemia (prediabetes or type 2 diabetes) ≥90 days prior to the day of screening with HbA1c of ≤ 10.0% as measured at the screening visit. * Arterial Hypertension * Hypercholesterolemia * Obstructive sleep apnea * History of stroke (ischemic or hemorrhagic) * History of myocardial infarction * Symptomatic peripheral artery disease (intermittent claudication with ankle-brachial index \<0.85, peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease) Exclusion Criteria: * Treatment with an GLP-1 receptor agonist within the previous 90 days. * Myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the previous 60 days. * Planned coronary, carotid or peripheral artery revascularization known on the day of screening. * eGFR \<25 mL/min/1.73 m² or intermittent hemodialysis or peritoneal dialysis. * Presence of acute pancreatitis within the last 180 days prior to screening. * History or presence of chronic pancreatitis. * Self-reported change in body weight of \>5 kg within 90 days before screening. * Bariatric surgery prior to screening or planned bariatric surgery within the trial time course. * Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed. * Known or suspected hypersensitivity to trial product(s) or related products. * Participation in any clinical trial of an approved or non-approved device for the treatment of aortic stenosis or obesity within 30 days before screening. * Receipt of any investigational medicinal product within 30 days before screening. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. * Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator. * Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.

Registry changes

No changes recorded since the trial was added.