Metabolic Surgery for Atrial Fibrillation Elimination

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

March 31, 2029

Conditions
Atrial FibrillationObesity 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.

Trial Locations (1)

44195

The Cleveland Clinic, Cleveland

All Listed Sponsors
collaborator

Ethicon, Inc.

INDUSTRY

collaborator

iRhythm Technologies, Inc.

INDUSTRY

lead

Ali Aminian

OTHER