This is a small research study to see whether losing weight with a minimally invasive weight-loss procedure called endoscopic sleeve gastroplasty (ESG) can help improve symptoms of a type of heart failure called HFpEF in adults with obesity.
BMI 30-50 kg/m2
Stable weight within the 3-months prior to enrollment (< 5 % weight loss or gain)
Documented heart failure, defined by satisfying at least one of the below criteria, with left ventricular ejection fraction ≥ 45% at time of screening
Elevated left ventricular filling pressures
Patients not willing to have an ESG procedure for the treatment of weight loss
History of prior bariatric surgery or procedure
Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
Esophageal, gastric or duodenal malignancy
Single group
Endoscopic sleeve gastroplasty (ESG)
Procedure/SurgeryThe endoscopic sleeve gastroplasty (ESG) is a minimally invasive, non-surgical weight-loss procedure. During the procedure, a flexible endoscope is passed through the mouth into the stomach. Using the OverStitch Endoscopic Suturing System, the physician places a series of sutures to reduce the stomach's volume.
To assess improvement in HFpEF symptom burden at 12 months post-ESG, as measured by change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline
Score range: 0-100- Higher scores indicate better health status and lower heart failure symptom burden. Positive changes from baseline reflect improvement
To assess percent body weight loss (TBWL) at 12 months post-ESG (%)
Percent total body weight loss (TBWL) at 12 months following ESG, calculated as the percentage change in body weight from baseline.
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