Waiting on Atrial Fibrillation Intervention Therapy: Weight loss before ablation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label trial assigns adults with atrial fibrillation and overweight/obesity to either semaglutide plus standard care or standard care alone for at least three months before their first pulmonary vein isolation ablation. All participants wear an implantable loop recorder to continuously monitor heart rhythm for 12 months after ablation, with rhythm outcomes assessed by blinded adjudicators. The study targets whether metabolic optimization with semaglutide can increase arrhythmia-free survival, reduce AF burden, and improve symptoms and quality of life, while integrating routine clinical practice and registry data. Semaglutide is used at 2.4 mg weekly in addition to standard medical management. The trial aims to inform whether pre-ablation weight management can enhance ablation success in this high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

To be included in the trial, subjects must meet all of the following criteria:

1. Provision of written informed consent prior to participation.
2. Age ≥18 years.
3. Scheduled for first-time catheter ablation for atrial fibrillation using a pulmonary vein isolation (PVI) technique.
4. Body Mass Index (BMI) ≥30 kg/m² (obesity) OR

   BMI ≥27 kg/m² (overweight) with one or more of the following comorbidities:
   * prediabetes (defined as HbA1c 39-47 mmol/mol or fasting glucose 5,6-6,9 mmol/L),
   * known diabetes type 2
   * known hypertension (prior diagnosis and/or treatment with antihypertensive medication)
   * new diagnosis of hypertension (according to ESC GL for hypertension: Systolic BP ≥140 mmHg and/or diastolic BP ≥ 90 mmHg based on two readings on two separate visits, OR Ambulatory BP monitoring (24h average) ≥ 130/80 mmHg)
   * dyslipidemia defined as either one of the following

     * Known diagnosis of hyperlipidemia or
     * Treatment with lipid lowering medication

   OR either of the following:
   * LDL \> 3.0 mmol/l
   * Total cholesterol \> 5 mmol/l
   * Triglycerides \> 1.7 mmol/l
   * HDL (\< 1 mmol/l if male, \< 1.2 mmol/l if female) AND/OR

     * atherosclerotic cardiovascular disease (prior myocardial infarction (MI), stroke, or peripheral arterial disease with claudication and ankle-brachial index \<0.85, prior revascularization, or amputation)
     * obstructive sleep apnea.
5. For 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:

* Morbid obesity (BMI \>40 kg/m²).
* Current use of GLP-1 receptor agonist therapy or dual agonist therapy within 6 months before screening.
* Current use of DPP-IV inhibitors.
* Diabetes type 1
* Known intolerance or contraindication to semaglutide.
* History of pancreatitis or recurrent hypoglycemia.
* Uncontrolled diabetic retinopathy
* Severe renal failure (estimated glomerular filtration rate \[eGFR\] \<15 mL/min/1.73 m² or in dialysis)
* Severe hepatic failure (decompensated liver disease Child-Pugh class C)
* Severe cardiac failure (NYHA class IV)
* Life expectancy \<12 months.
* Inability to self-administer the investigational medicinal product.
* Prior catheter ablation procedure for atrial fibrillation.
* Pregnancy, breastfeeding, or planned pregnancy during or within two months after the study period.
* Participation in another interventional clinical trial within the past 30 days.

Where it's running

• Karolinska University Hospital
  Stockholm, Sweden Recruiting

Study contacts

• Principal investigator: Emma Svennberg, MD PhD — Karolinska Institutet
• Study coordinator: Emma Svennberg, MD PhD
• Email: emma.svennberg@regionstockholm.se
• Phone: +46739584822

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.