NCT07027969

Metabolic Surgery for Atrial Fibrillation Elimination

Efficacy of Cardiometabolic Risk Factor Control Through Metabolic Surgery on Management and Severity of Atrial Fibrillation: METSAFE Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ali Aminian · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is randomized trial of 100 patients with BMI ≥35 kg/m2 and AF. Patients who met the initial screening criteria (including presence of at least 1% AF burden during a 2-week monitoring period with an ambulatory cardiac monitor) will be invited for possible enrollment. Patients will then be randomized 1:1 to MBS group versus nonsurgical control group and will be followed for 12 months (phase 1) and then for an additional 18 months (phase 2). Interventions include Roux-en-Y Gastric Bypass or Sleeve Gastrectomy surgical procedures based on the shared medical decision between the bariatric surgeon and patients considering the patient's conditions. In the control group, patients are allowed to take anti-obesity medications (AOMs) that are not contraindicated in patients with AF at the discretion of obesity medicine specialists. Lifestyle and risk factor modification in both groups will consist of targeted and personalized diet plans, exercise, and risk factor reduction, including optimal therapies for T2DM, hypertension, dyslipidemia, heart failure, coronary artery disease, and OSA.

Conditions

• Atrial Fibrillation
• Obesity and Obesity-related Medical Conditions

Interventions

Type	Name	Description
PROCEDURE	Roux-en-Y Gastric Bypass or Sleeve Gastrectomy	Patients receive either RYGB or SG. The surgical risk, differential impact of each procedure on body weight and other obesity-related diseases, presence of other medical and mental problems, patient's behavioral factors (e.g., postoperative compliance, active smoking), medications, and goals will be considered when the patient and local medical team make a shared decision about the most appropriate surgical procedure.
DRUG	Anti-Obesity Medication (AOM) treatment	Implementation of obesity pharmacotherapy in the nonsurgical group includes initial assessment of side effects and response, followed by achieving a clinically meaningful weight loss (5% weight loss) after three months. Once this goal is reached, AOMs will be continued throughout the study. If a weight plateau is reached within the first AOM, then another AOM may be added in combination in a stepwise fashion. The choice of AOMs considered may include metformin, topiramate, liraglutide, dulaglutide, semaglutide, tirzepatide, and empagliflozin.

Timeline

• Start date: 2026-11-01
• Primary completion: 2029-12-31
• Completion: 2030-03-31
• First posted: 2025-06-19
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study