Pilot Study of Endoscopic Sleeve Gastroplasty for Obese Patients With Heart Failure and Preserved Ejection Fraction

Pilot Clinical Study Evaluating Endoscopic Sleeve Gastroplasty (ESG) for Obese Patients With Heart Failure With Preserved Ejection Fraction

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.

During the ESG procedure, a specially trained doctor uses a flexible tube passed through the mouth to place stitches inside the stomach. This makes the stomach smaller so people feel full sooner and eat less, which can help with weight loss. The procedure uses the OverStitch Endoscopic Suturing System and is performed by trained gastroenterologists or surgeons.

The study is for adults with obesity who have a BMI between 30 and 50 and have not been able to lose weight or keep it off through diet, exercise, or other non-surgical approaches.

The goal of the study is to learn whether weight loss after ESG can improve heart failure symptoms, such as shortness of breath, tiredness, and difficulty with physical activity.

Inclusion Criteria:

• 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
• Elevate natriuretic peptide levels
• Echocardiographic abnormalities consistent with HFpEF
• Hospitalization for heart failure in prior 12 months plus ongoing treatment with diuretics
• NYHA Functional Class II-IV
• KCCQ-CSS score < 90
• 6-minute walk test > 100 m
• No hospitalizations due to HF between screening and baseline visit
• Satisfies the indications for use and intended population as described in the IFU for Overstitch Endoscopic Suturing System
• Is not currently taking any over the counter or prescribed weight loss supplements or any anti-obesity medications
• Agrees not to take additional over the counter or prescribed weight loss supplements / medications during study participation
• Medications for management of diabetes that are stable for the last 6 months, no changes to type or dose and no expected changes during study participation
• Agrees to the follow-up requirements of the study and provides informed consent

Exclusion Criteria:

• 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
• Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
• Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
• Prior surgical or endoscopic anti-reflux procedure
• Current or planned management of Type 2 Diabetes with incretin medications
• Inability or unwillingness to comply with protocol requirements related to visits
• Investigator's medical judgement that the subject is not a candidate for the ESG procedure
• MI, stroke, hospitalization for HF, unstable angina pectoris, or TIA within 30 days prior to the day of screening
• SBP >160 mm Hg at screening
• Planned coronary, carotid or peripheral artery revascularization
• Any other condition judged by the investigator to be the primary cause of dyspnea
• End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis
• Presence or history of malignant neoplasm within 5 years prior to the day of screening Basal and squamous cell cancer and any carcinoma in-situ are allowed
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
• Participation in any clinical trial of an approved or non-approved device for the treatment of HF or obesity within 30 days before screening
• Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator
• Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol