CompletedNot Applicable

SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients

Germany142 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 12 months

Trial details

NCT IDNCT02064114

SponsorUniversitätsklinikum Hamburg-Eppendorf

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-16

View on ClinicalTrials.gov More Atrial Fibrillation trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.