Metabolic Surgery for Atrial Fibrillation Elimination (NCT07027969) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Metabolic Surgery for Atrial Fibrillation Elimination
United States100 participantsStarted 2026-11-01
Plain-language summary
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. It is estimated that between 3 and 6 million Americans are currently living with AF, while 12 million people in the United States will have AF in 2030. Obesity and its comorbidities such as type 2 diabetes (T2DM), hypertension, and obstructive sleep apnea (OSA) are major risk factors for development and progression of AF. Metabolic and Bariatric Surgery (MBS) is the most effective currently available treatment for obesity. Patients typically lose 20 to 35 percent of body weight after surgery which is often sustained for many years. MBS can improve all 5 major risk factors of AF including obesity, hypertension, T2DM, OSA, and systemic inflammation.
The purpose of the study is to understand if MBS can affect the severity of AF and the toll AF's symptoms take on patients.
Who can participate
Age range18 Years – 80 Years
SexALL
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
✓. Is a candidate for general anesthesia
✓. Is eligible for metabolic surgery (RYGB or SG)
✓. Is ≥18 and ≤80 years old
✓. has a BMI ≥35 and ≤65 kg/m2
✓. has AF criteria, which:
✓. Must be documented by EKG or cardiac monitor or Zio XT Patch
✓. Must have symptomatic AF
✓. 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.
Exclusion criteria
✕. Significant cardiac valvular disease (planned to undergo cardiac valve intervention/surgery in the next 12 months)
✕. Significant atherosclerotic disease (planned to undergo coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)
What they're measuring
1
Relative change in total duration of being in atrial fibrillation (AF)
✕. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V
✕. Classified as New York Heart Association Class IV
✕. Left ventricular ejection fraction \<20% at the time of screening
✕. Hospitalization for myocardial infarction, unstable angina, stroke, transient ischemic attack, heart surgery, coronary stent placement in the past 6 months
✕. 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)