Not yet recruitingPhase 4

Metabolic Surgery for Atrial Fibrillation Elimination

Efficacy of Cardiometabolic Risk Factor Control Through Metabolic Surgery on Management and Severity of Atrial Fibrillation: METSAFE Randomized Clinical Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether weight-loss surgery can reduce atrial fibrillation (AF), an uneven heartbeat, and its symptoms. It is for adults ages 18 to 80 with obesity and AF symptoms who qualify for surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be ages 18 to 80 with a body mass index (BMI), a measure of body size, from 35 to 65.
  • Qualify for gastric bypass or sleeve surgery and for medicine that keeps you asleep during surgery.
  • Have AF symptoms and AF recorded by a heart test or monitor. A heart specialist must confirm that you qualify.
  • Have ongoing AF, or AF that comes and goes with at least one episode lasting 5 minutes or more in the past 3 months. AF must occur during at least 1% of a 2-week heart monitor test.
  • Have never had an AF ablation procedure, which treats heart tissue to control AF, or have had one that failed.
  • People with or without type 2 diabetes may join. If you have it, your diabetes medicine dose must be stable for at least 3 months, and your HbA1c blood sugar level must be 12% or less.
  • Be willing and able to join any study group, understand the choices, and follow the study rules.
  • If you can become pregnant, have negative pregnancy tests at screening and group assignment. Agree to use reliable birth control for 2 years.

Who can't join

  • Planned heart valve or artery-opening treatment in the next 12 months; very severe heart or lung disease; class IV heart failure; or a heart pumping level below 20%.
  • Hospital care in the past 6 months for a heart attack, unstable chest pain, stroke, mini-stroke, heart surgery, or placement of a heart artery stent.
  • Past weight-loss surgery, unless you only had a stomach balloon or band removed more than a year before joining; a past organ transplant; or type 1 or autoimmune diabetes.
  • Kidney filtering level below 30 or dialysis; severe liver scarring with complications; liver enzyme levels above 300; or anemia, a low red blood cell level, with hemoglobin below 9.
  • Use of an experimental treatment; active cancer other than non-melanoma skin cancer; another illness that limits expected life to less than 3 years; or any condition the study doctor thinks makes joining too risky.
  • An average of more than 2 alcoholic drinks a day; or mental health or substance use problems that the study team thinks make weight-loss surgery unsuitable.
  • Being unable to understand the study's risks, benefits, or rules, or unable to give informed consent; or plans to move outside Northeast Ohio within 12 months.
  • Pregnancy, breastfeeding, plans to become pregnant, lack of adequate birth control, or a known allergy to adhesives, such as sticky medical patches.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

OH