Evaluation of the Alleviant Medical Percutaneously Created Inter-atrial Shunt on Heart Failure Symptoms in Patients with Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction

Abstract

The purpose of this study is to evaluate the safety and feasibility of the Alleviant Medical Percutaneous Interatrial Shunt System for patients with Heart Failure with preserved or mid range Left Ventricular Ejection Fraction (HFpEF).

Who is it for? You may be eligible for this study if you are aged 40 or older and have Class 2 (and a history of greater than Class 2), Class 3 or ambulatory Class 4 Heart Failure

Study details All participants will have the interatrial shunt created during a procedure under general anaesthesia in a cardiac catheterisation laboratory. All participants will be followed-up according to the protocol specific endpoints. Patients will undergo diagnostic tests during screening including transthoracic echocardiography, exercise haemodynamic evaluation, and laboratory (blood) tests. These tests will be repeated during follow-up. Additional imaging may occur during the index procedure (transoesophageal or intracardiac echocardiography), and additional imaging studies may be performed during follow-up including cardiac MR and/or cardiac CT. Additional questionnaires and a study specific activity monitor will be utilized during screening and follow-up

It is hoped that this research will provide information into the non-pharmacologic treatments of heart failure symptoms thereby providing future non-pharmacologic related options for the disease.