Metabolic Surgery for Atrial Fibrillation Elimination
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
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
Treatments tested in this trial
- Roux-en-Y Gastric Bypass or Sleeve Gastrectomy
- Anti-Obesity Medication (AOM) treatment
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ali Aminian
Lead sponsor
The Cleveland Clinic
Sponsor institution
Ethicon, Inc.
Collaborator
iRhythm Technologies, Inc.
Collaborator
Source ClinicalTrials.gov