Current partner codePEPTIDESDE
NCT07027969·Phase 4·INTERVENTIONAL

Metabolic Surgery for Atrial Fibrillation Elimination

Status

Not yet recruiting

Phase

Phase 4

Enrollment

100

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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

From registration to results.

  1. First posted

    Jun 19, 2025

  2. Study start

    Nov 1, 2026

  3. Primary completion

    Dec 31, 2029

  4. Study completion

    Mar 31, 2030

  5. Results posted

    Not reported

  6. Registry updated

    Apr 17, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · First 52 weeks of the study

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).

Secondary outcomes

Presence of at least 1 AF episode

Time frame · First 52 weeks of the study

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

Change in number of AF episodes (≥30 seconds)

Time frame · First 52 weeks of the study

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.

Change in number of AF espisodes longer than 6 minutes

Time frame · First 52 weeks of the study

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.

Change in the longest AF duration

Time frame · First 52 weeks of the study

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

Change in the second longest AF duration

Time frame · First 52 weeks of the study

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

Change in the AF type

Time frame · First 52 weeks of the study

Change in the AF type (e.g. regression from or progression to persistent form of AF)

Change in AF Symptom burden

Time frame · First 52 weeks of the study

Change in AF Symptom burden and severity assessed by the Toronto AF Severity Score (AFSS)

Relapse of AF after ablation

Time frame · Throughout the study, 130 weeks

Number of relapses of AF after ablation in each group \*Since more ablation is expected in the second phase of study, this end point will be more relevant in the phase 2 of study.

Change in cardiac structure

Time frame · First 52 weeks of the study

Change in cardiac structure assessed by transthoracic echocardiography including LA and LV size, morphology, and function

Change in weight

Time frame · First 52 weeks of the study

Percent and absolute changes in body weight and BMI

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
Yes

INCLUSION CRITERIA Entry into the study would require that the patient: 1. Is a candidate for general anesthesia 2. Is eligible for metabolic surgery (RYGB or SG) 3. Is ≥18 and ≤80 years old 4. has a BMI ≥35 and ≤65 kg/m2 5. has AF criteria, which: 1. Must be documented by EKG or cardiac monitor or Zio XT Patch 2. Must have symptomatic AF 3. 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. 4. Must have a minimum burden of 1% during a 2-week screening time with an ambulatory noninvasive cardiac monitor. 5. Must be assessed and confirmed by an expert cardiologist (e.g., cardiac electrophysiologist) to meet eligibility. 6. Patients without history of prior AF ablation/PVI procedure or with history of prior failed AF ablation/PVI procedure are eligible for the study. 7. 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%. 8. Have the ability and willingness to participate in the study and agree to any of the arms involved in the study. 9. Able to understand the options and to comply with the requirements of each arm. 10. Have a negative urine pregnancy test at screening and randomization visits for women of childbearing potential. 11. Women, of childbearing age, must agree to use reliable method of contraception for 2 years. EXCLUSION CRITERIA 1. Significant cardiac valvular disease (planned to undergo cardiac valve intervention/surgery in the next 12 months) 2. Significant atherosclerotic disease (planned to undergo coronary, carotid, or peripheral artery revascularization procedures in the next 12 months) 3. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V 4. Classified as New York Heart Association Class IV 5. Left ventricular ejection fraction \<20% at the time of screening 6. Hospitalization for myocardial infarction, unstable angina, stroke, transient ischemic attack, heart surgery, coronary stent placement in the past 6 months 7. 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) 8. History of solid organ transplant 9. Type 1 diabetes or autoimmune diabetes 10. eGFR \< 30 mL/min/1.73 m2 at screening or being on dialysis 11. Decompensated cirrhosis characterized by ascites, hepatic encephalopathy, portal hypertension, or esophageal varices. 12. Anemia defined as hemoglobin less than 9 g/dL 13. Use of investigational therapy 14. Liver transaminase level \>300 U/L 15. Significant alcohol use (average \>2 drinks/day) 16. Presence of active malignancy (except non-melanoma skin cancer) 17. Life expectancy less than 3 years due to concomitant diseases 18. Major mental health, psychological disorders, or substance abuse disorders that in the opinion of the investigators could disqualify the patient from metabolic surgery 19. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study 20. Unable to understand the risks, benefits and compliance requirements of study 21. Lack capacity to give informed consent 22. Plans to move outside the primary location of study (Northeast Ohio) within the next 12 months 23. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures 24. Known adhesive allergies

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

The Cleveland Clinic

Cleveland, Ohio, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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