Metabolic Surgery for Atrial Fibrillation Elimination

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Ali Aminian
Study ID
NCT07027969
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metabolic Surgery
    Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)
  • Other: Control group (nonsurgical standard of care for obesity)
    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.

Primary Outcome Measure

Relative change in total duration of being in atrial fibrillation (AF) [ Time Frame: First 52 weeks of the study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Cleveland ClinicClevelandOhio44195
Chytaine Hall
[email protected]
(216) 445-3983

Find similar trials in Cleveland, OH

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
The Cleveland Clinic· Cleveland, OH

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