Semaglutide for Atrial fibrillation

Inclusion criteria

• {"criterion_text":"- Provision of written informed consent prior to participation.\n- Age ≥18 years\n- Scheduled for first-time catheter ablation for atrial fibrillation using a pulmonary vein isolation (PVI) technique.\n- 4.\tBody Mass Index (BMI) ≥30 kg/m² (obesity) OR BMI ≥27 kg/m² (overweight) with one or more of the comorbidities listed in the protocol under section 6.1, inclusion criteria nr. 4.\n- 5.\tFor women of childbearing potential: Inclusion after a highly sensitive negative pregnancy test and agreement to use highly effective contraception during the study period (e.g., hormonal contraception, intrauterine device, or barrier method combined with spermicide)."}

Exclusion criteria

• {"criterion_text":"- Morbid obesity (BMI >40 kg/m²).\n- History of pancreatitis or recurrent hypoglycemia.\n- Uncontrolled diabetic retinopathy\n- Severe renal failure (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m² or in dialysis)\n- Severe hepatic failure (decompensated liver disease Child–Pugh class C)\n- Severe cardiac failure (NYHA class IV)\n- Diabetes type 1\n- Life expectancy <12 months.\n- Inability to self-administer the investigational medicinal product.\n- Prior catheter ablation procedure for atrial fibrillation.\n- Pregnancy, breastfeeding, or planned pregnancy during or within two months after the study period.\n- Participation in another interventional clinical trial within the past 30 days.\n- Current use of GLP-1 receptor agonist therapy or dual agonist therapy within 6 months before screening.\n- Current use of DPP-IV inhibitors\n- Known intolerance or contraindication to semaglutide."}

Primary endpoints

• {"endpoint_text":"- Primary variable: Freedom from atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds as detected by continuous monitoring via implantable loop recorder at 12 months post-ablation. Events within the initial 3-month blanking period will not be included.","definition_or_measurement_approach":"Detected by continuous monitoring via implantable loop recorder at 12 months post-ablation; events within the initial 3-month blanking period are excluded."}

Sweden

Earliest CTIS Part Ii Submission Date

25-11-2025

Latest Decision Or Authorization Date

17-12-2025

Processing Time Days

22

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden