SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients (SORT-AF)

Study hypothesis: Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an obesity treatment after atrial fibrillation ablation. Study design: A prospective randomized, open-label clinical trial.

Study protocol: The purpose of this study is to proof a professional care of overweight patients with symptomatic atrial fibrillation, as well as the treatment of the risk factors for atrial fibrillation, especially obstructive sleep apnea and hypertension. There is a 1:1 randomization. In the intervention group, patients are followed up in a 6-month intensive care after atrial fibrillation ablation. During the follow up time patients will visit the nutritional advice every two weeks for 6 months. The Follow-up in the control group is standard of care. At baseline, a screening test for obstructive sleep apnea and arterial hypertension will be performed as standard care. The documentation of atrial fibrillation after ablation is made possible by the implantation of an event recorder before atrial fibrillation ablation. Follow up: A follow-up will be performed after 3,6 and 12 months in both groups. Patients in the intervention group will be followed-up every 2 weeks in the first 6 months.

Start of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure.

Start of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure.

The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation

Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months

Inclusion Criteria: Age ≥ 18 years Overweight with a BMI ≥ 30 Obtained written informed consent Symptomatic atrial fibrillation with indication for ablation Exclusion Criteria: Age <18 years Permanent atrial fibrillation (failed Cardioversion or episode duration > 12 months) Previous surgical or interventional therapy of atrial fibrillation BMI > 40 Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment History of hemorrhagic diathesis or other coagulopathies Contraindications for oral anticoagulation Hyper- or hypothyroidism Drug or chronic alcohol abuse Has any condition that would make participation not be in the best interest of the subject Incompliance Unable to perform athletic exercise due to disease or disability Resident outside Hamburg

Gessler N, Willems S, Steven D, Aberle J, Akbulak RO, Gosau N, Hoffmann BA, Meyer C, Sultan A, Tilz R, Vogler J, Wohlmuth P, Scholz S, Gunawardene MA, Eickholt C, Luker J. Supervised Obesity Reduction Trial for AF ablation patients: results from the SORT-AF trial. Europace. 2021 Oct 9;23(10):1548-1558. doi: 10.1093/europace/euab122.