Pilot Study of Endoscopic Sleeve Gastroplasty for Obese Patients With Heart Failure and 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.

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