Could Weight-Loss surgery tame a common heart rhythm disorder?
NCT ID NCT07027969
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether metabolic surgery (like gastric bypass) can reduce the severity of atrial fibrillation (AF), a common heart rhythm problem, in people with obesity. About 100 adults with AF and a BMI between 35 and 65 will be randomly assigned to either surgery or medication. The main goal is to see if surgery lowers the amount of time spent in AF over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metabolic surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) or anti-obesity medication
- What this could lead to
- If successful, this could show that weight-loss surgery is an effective way to manage atrial fibrillation in people with obesity, potentially reducing symptoms and the need for other treatments.
- What could go wrong
- This is a small, early-phase trial with only 100 participants. Surgery carries risks like infection or complications, and the results may not apply to all patients with atrial fibrillation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA Entry into the study would require that the patient: 1. Is a candidate for general anesthesia 2. Is eligible for metabolic surgery (RYGB or SG) 3. Is ≥18 and ≤80 years old 4. has a BMI ≥35 and ≤65 kg/m2 5. has AF criteria, which: 1. Must be documented by EKG or cardiac monitor or Zio XT Patch 2. Must have symptomatic AF 3. In terms of types of AF, either paroxysmal AF with at least one episode lasting ≥5 minutes in the last 3 months prior to screening, or persistent AF, or longstanding AF. 4. Must have a minimum burden of 1% during a 2-week screening time with an ambulatory noninvasive cardiac monitor. 5. Must be assessed and confirmed by an expert cardiologist (e.g., cardiac electrophysiologist) to meet eligibility. 6. Patients without history of prior AF ablation/PVI procedure or with history of prior failed AF ablation/PVI procedure are eligible for the study. 7. Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin) for at least 3 months prior to entry, with HbA1c ≤12%. 8. Have the ability and willingness to participate in the study and agree to any of the arms involved in the study. 9. Able to understand the options and to comply with the requirements of each arm. 10. Have a negative urine pregnancy test at screening and randomization visits for women of childbearing potential. 11. Women, of childbearing age, must agree to use reliable method of contraception for 2 years. EXCLUSION CRITERIA 1. Significant cardiac valvular disease (planned to undergo cardiac valve intervention/surgery in the next 12 months) 2. Significant atherosclerotic disease (planned to undergo coronary, carotid, or peripheral artery revascularization procedures in the next 12 months) 3. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V 4. Classified as New York Heart Association Class IV 5. Left ventricular ejection fraction \<20% at the time of screening 6. Hospitalization for myocardial infarction, unstable angina, stroke, transient ischemic attack, heart surgery, coronary stent placement in the past 6 months 7. Prior bariatric and metabolic surgery of any kind (patients who had a gastric balloon or gastric band that were removed more than one year prior to enrollment are allowed to participate) 8. History of solid organ transplant 9. Type 1 diabetes or autoimmune diabetes 10. eGFR \< 30 mL/min/1.73 m2 at screening or being on dialysis 11. Decompensated cirrhosis characterized by ascites, hepatic encephalopathy, portal hypertension, or esophageal varices. 12. Anemia defined as hemoglobin less than 9 g/dL 13. Use of investigational therapy 14. Liver transaminase level \>300 U/L 15. Significant alcohol use (average \>2 drinks/day) 16. Presence of active malignancy (except non-melanoma skin cancer) 17. Life expectancy less than 3 years due to concomitant diseases 18. Major mental health, psychological disorders, or substance abuse disorders that in the opinion of the investigators could disqualify the patient from metabolic surgery 19. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study 20. Unable to understand the risks, benefits and compliance requirements of study 21. Lack capacity to give informed consent 22. Plans to move outside the primary location of study (Northeast Ohio) within the next 12 months 23. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures 24. Known adhesive allergies
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Cleveland Clinic
Cleveland, Ohio, 44195, United States
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