SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients (SORT-AF)
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ClinicalTrials.gov Identifier: NCT02064114 |
Recruitment Status :
Completed
First Posted : February 17, 2014
Last Update Posted : May 22, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation Obesity Sleep Apnea | Procedure: Intervention group Procedure: control group | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 142 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Supervised Obesity Reduction Trial for AF Ablation Patients |
Actual Study Start Date : | January 2014 |
Actual Primary Completion Date : | January 16, 2020 |
Actual Study Completion Date : | January 16, 2020 |

Arm | Intervention/treatment |
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Active Comparator: Intervention group
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.
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Procedure: Intervention group
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. |
Active Comparator: control group
conventional treatment, followed for a period of 3,6 and 12 months after the procedure.
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Procedure: control group
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 [ Time Frame: 12 months ]AF burden is defined as overall percentage of AF during the observed period.
- 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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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064114
Germany | |
Universitäres Herzzentrum Lübeck | |
Lübeck, Schleswig-Holstein, Germany, 23562 | |
Herzzentrum der Universität zu Köln | |
Cologne, Germany | |
Asklepios ST. Georg | |
Hamburg, Germany, 20246 | |
Universitätsklinikum Hamburg-Eppendorf | |
Hamburg, Germany, 20246 |
Principal Investigator: | Christian Meyer | University Heart Center Hamburg |
Responsible Party: | Universitätsklinikum Hamburg-Eppendorf |
ClinicalTrials.gov Identifier: | NCT02064114 |
Other Study ID Numbers: |
PV4300 |
First Posted: | February 17, 2014 Key Record Dates |
Last Update Posted: | May 22, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
BMI >40 |
Atrial Fibrillation Obesity Overnutrition Nutrition Disorders Overweight |
Body Weight Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |