Metabolic Surgery for Atrial Fibrillation Elimination

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.

Conditions

• Atrial Fibrillation
• Obesity and Obesity-related Medical Conditions

Interventions

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.

Sponsors & Collaborators

• Ethicon, Inc.

  collaborator INDUSTRY

• iRhythm Technologies, Inc.

  collaborator INDUSTRY

• Ali Aminian

  lead OTHER

Principal Investigators

• Ali Aminani · Bariatric Research Medical Director

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-11-01

Primary Completion

2029-12-31

Completion

2030-03-31

FDA Drug

Yes

Countries

• United States

Study Locations