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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
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.
Followed for a period of 3,6 and 12 months after the procedure.
Universitäres Herzzentrum Lübeck
Lübeck, Schleswig-Holstein, Germany
Herzzentrum der Universität zu Köln
Cologne, Germany
Asklepios ST. Georg
Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation
AF burden is defined as overall percentage of AF during the observed period.
Time frame: 12 months
AF burden between 0 and 12 months after first AF ablation
Time frame: 12 months
AF burden between 0 and 3, 3 to 6 and 6 to 12 months after first AF ablation
Time frame: 12 months
Freedom of AF (after 3 months blanking period)
Time frame: 12 months
Time to first recurrent AF (after 3 months blanking period)
Time frame: 12 months
Body Mass Index (BMI) change from BL to 12 months
Time frame: 12 months
Exercise capacity change from BL to 12 months
Time frame: 12 months
Mean blood pressure change from BL to 12 months
Time frame: 12 months
Number of repeated AF ablation procedures
Time frame: 12 months
Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months
Time frame: 12 months
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