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

Korábbi kezelés

• History of prior bariatric surgery or procedure
• Prior surgical or endoscopic anti-reflux procedure
• MI, stroke, hospitalization for HF, unstable angina pectoris, or TIA within 30 days prior to the day of screening
• 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

Más betegség

• Esophageal, gastric or duodenal malignancy
• Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
• Current or planned management of Type 2 Diabetes with incretin medications
• 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

Laborértékek

• 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

Egyéb

• Patients not willing to have an ESG procedure for the treatment of weight loss
• Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
• 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
• SBP >160 mm Hg at screening
• Planned coronary, carotid or peripheral artery revascularization
• 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

• 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