Metabolic Surgery for Atrial Fibrillation Elimination

NCT07027969 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 23-1039
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atrial Fibrillation; Bariatric Surgery; Metabolic Syndrome; Weight Loss Surgery; Roux-en-Y gastric bypass; Sleeve Gastrectomy; GLP-1 Receptor Agonist; Tirzepatide; Semaglutide

Outcome Measures

Primary Outcomes (1)

• Relative change in total duration of being in atrial fibrillation (AF)

  Relative change from baseline to 52 weeks in the percentage total duration of being in AF during a 2-week monitoring period (i.e., %burden), assessed by the Zio XT Patch (iRhythm).

  First 52 weeks of the study

Secondary Outcomes (10)

• Presence of at least 1 AF episode

  First 52 weeks of the study

• Change in number of AF episodes (≥30 seconds)

  First 52 weeks of the study

• Change in number of AF espisodes longer than 6 minutes

  First 52 weeks of the study

• Change in the longest AF duration

  First 52 weeks of the study

• Change in the second longest AF duration

  First 52 weeks of the study

Other Outcomes (20)

• Percentage of Participants Achieving Weight Loss Milestones

  First 52 weeks of the study

• Excess Weight Loss Percentage

  First 52 weeks of the study

• Change in waist circumference

  First 52 weeks of the study

Study Arms (2)

Metabolic Surgery

ACTIVE COMPARATOR

Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)

Procedure: Roux-en-Y Gastric Bypass or Sleeve Gastrectomy

Control group (nonsurgical standard of care for obesity)

OTHER

In the Control group, the subjects will be receiving standard of care for nonsurgical management of obesity, including possible AOMs that are not contraindicated in patients with AF at the discretion of obesity medicine specialists.

Drug: Anti-Obesity Medication (AOM) treatment

Interventions

Anti-Obesity Medication (AOM) treatment DRUG

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.

Control group (nonsurgical standard of care for obesity)

Roux-en-Y Gastric Bypass or Sleeve Gastrectomy PROCEDURE

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.

Also known as: Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG), Bariatric Surgery

Metabolic Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)
• History of solid organ transplant
• Type 1 diabetes or autoimmune diabetes
• eGFR \< 30 mL/min/1.73 m2 at screening or being on dialysis
• Decompensated cirrhosis characterized by ascites, hepatic encephalopathy, portal hypertension, or esophageal varices.
• Anemia defined as hemoglobin less than 9 g/dL
• Use of investigational therapy
• Liver transaminase level \>300 U/L
• Significant alcohol use (average \>2 drinks/day)

Sponsors & Collaborators

• Ali Aminian: lead
• Ethicon, Inc.: collaborator
• iRhythm Technologies, Inc.: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Obesity; Metabolic Syndrome

Interventions

Gastric Bypass; Bariatric Surgery; Collagen Type II; Therapeutics

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures; Fibrillar Collagens; Collagen; Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Ali Aminani

  Bariatric Research Medical Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chytaine Hall

CONTACT

216-445-3983; hallc1@ccf.org

Ali Aminian

CONTACT

2164450045; aminiaa@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients and investigators will not be blinded to treatment assignment. However, the clinical assessors of cardiac rhythm recorders are blinded to the study arms; Assessment of the primary endpoint will be based on the blinded downloads and interpretation of Zio XT Patch (iRhythm) data yielding the AF burden.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Bariatric & Metabolic Institute

Model Details: METSAFE is a randomized open-label blinded-endpoint single-center controlled efficacy/safety study with 2 parallel groups of patients with obesity and AF who will either receive metabolic surgery or nonsurgical obesity care for 30 months. The study has 2 phases: the first 12 months and the subsequent 18 months.

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)