Metabolic Surgery for Atrial Fibrillation Elimination

Prior treatment

• 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)
• Use of investigational therapy
• Life expectancy less than 3 years due to concomitant diseases

Other illness

• 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)
• Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V
• Classified as New York Heart Association Class IV
• Hospitalization for myocardial infarction, unstable angina, stroke, transient ischemic attack, heart surgery, coronary stent placement in the past 6 months
• History of solid organ transplant
• Type 1 diabetes or autoimmune diabetes
• Decompensated cirrhosis characterized by ascites, hepatic encephalopathy, portal hypertension, or esophageal varices.
• Presence of active malignancy (except non-melanoma skin cancer)
• Major mental health, psychological disorders, or substance abuse disorders that in the opinion of the investigators could disqualify the patient from metabolic surgery
• Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
• Known adhesive allergies

Lab values

• Left ventricular ejection fraction \<20% at the time of screening
• eGFR \< 30 mL/min/1.73 m2 at screening or being on dialysis
• Anemia defined as hemoglobin less than 9 g/dL
• Liver transaminase level \>300 U/L

Other

• Significant alcohol use (average \>2 drinks/day)
• Unable to understand the risks, benefits and compliance requirements of study
• Lack capacity to give informed consent
• Plans to move outside the primary location of study (Northeast Ohio) within the next 12 months
• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures

• Entry into the study would require that the patient:
• 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.
  • Must have a minimum burden of 1% during a 2-week screening time with an ambulatory noninvasive cardiac monitor.
  • Must be assessed and confirmed by an expert cardiologist (e.g., cardiac electrophysiologist) to meet eligibility.
• Patients without history of prior AF ablation/PVI procedure or with history of prior failed AF ablation/PVI procedure are eligible for the study.
• 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%.
• Have the ability and willingness to participate in the study and agree to any of the arms involved in the study.
• Able to understand the options and to comply with the requirements of each arm.
• Have a negative urine pregnancy test at screening and randomization visits for women of childbearing potential.
• Women, of childbearing age, must agree to use reliable method of contraception for 2 years.