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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | 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. |
|
| control group | Active Comparator | conventional treatment, followed for a period of 3,6 and 12 months after the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| AF burden between 0 and 12 months after first AF ablation | 12 months | |
| AF burden between 0 and 3, 3 to 6 and 6 to 12 months after first AF ablation | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Meyer | University Heart Center Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäres Herzzentrum Lübeck | Lübeck | Schleswig-Holstein | 23562 | Germany | ||
| Herzzentrum der Universität zu Köln |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33895833 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D009765 | Obesity |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| control group | Procedure | Followed for a period of 3,6 and 12 months after the procedure. |
|
| Freedom of AF (after 3 months blanking period) |
| 12 months |
| Time to first recurrent AF (after 3 months blanking period) | 12 months |
| Body Mass Index (BMI) change from BL to 12 months | 12 months |
| Exercise capacity change from BL to 12 months | 12 months |
| Mean blood pressure change from BL to 12 months | 12 months |
| Number of repeated AF ablation procedures | 12 months |
| Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months | 12 months |
| Cologne |
| Germany |
| Asklepios ST. Georg | Hamburg | 20246 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D008722 | Methods |