SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Supervised Obesity Reduction Trial for AF Ablation Patients

Conditions
-----------------
Atrial Fibrillation, Obesity, Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: Intervention group
* Procedure: control group


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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. | Procedure: Intervention group<br>* 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.<br>|
| Active Comparator: control group<br>conventional treatment, followed for a period of 3,6 and 12 months after the procedure. | Procedure: control group<br>* Followed for a period of 3,6 and 12 months after the procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMI >40