Metabolic Surgery for Atrial Fibrillation Elimination

ConditionsAtrial Fibrillation Obesity and Obesity-related Medical Conditions

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-80

SponsorAli Aminian

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Roux-en-Y Gastric Bypass or Sleeve Gastrectomy
Procedure/Surgery
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.
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Metabolic SurgeryActive comparator 1 intervention

Group B: Control group (nonsurgical standard of care for obesity)Other 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

First 52 weeks of the study

Secondary outcomes

Presence of at least 1 AF episode

Presence of at least 1 AF episode (present or absent) in a 2-week monitoring time by Zio XT Patch at 52 weeks.

Time frame

First 52 weeks of the study

Change in number of AF episodes (≥30 seconds)

Change in Zio XT Patch derived variables from baseline to 52 weeks including number of AF episodes (≥30 seconds) in a 2-week monitoring time.

Time frame

First 52 weeks of the study

Change in number of AF espisodes longer than 6 minutes

Change in Zio XT Patch derived variables from baseline to 52 weeks including number of AF episodes longer than 6 minutes in a 2-week monitoring time.

Time frame

First 52 weeks of the study

Change in the longest AF duration

Change in Zio XT Patch derived variables from baseline to 52 weeks including the longest AF duration in a 2-week monitoring time.

Time frame

First 52 weeks of the study

Other outcomes

Percentage of Participants Achieving Weight Loss Milestones

Percentage of participants achieving ≥ 5%, ≥ 10%, ≥ 15%, ≥ 20%, ≥ 25%, ≥ 30%, ≥ 35% weight loss from baseline (yes/no)

Time frame

First 52 weeks of the study

Excess Weight Loss Percentage

Percentage of excess weight loss, calculated by dividing the difference between initial BMI and final BMI by the difference between initial BMI and a target BMI of 25

Time frame

First 52 weeks of the study

Change in waist circumference

Change in waist circumferential measurement above the level of the iliac crests measured in centimeters from baseline to 52 weeks

Time frame

First 52 weeks of the study

Change in physical activity

Change in physical activity, tracked by a commercial wearable device

Time frame

First 52 weeks of the study

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ali Aminian

Lead sponsor

The Cleveland Clinic

Sponsor institution

Ethicon, Inc.

Collaborator

iRhythm Technologies, Inc.

Collaborator

Source ClinicalTrials.gov

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