None listed
Conditions
Brief summary
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.
Interventions
Patients with Heart Failure with preserved or mid range Ejection Fraction (HFpEF) fulfilling the inclusion / exclusion criteria will be treated once with the Alleviant Medical Interatrial Shunt System. This system creates a controlled size interatrial shunt via a proprietary catheter to the atrial septum during one treatment procedure. The therapy is delivered administered under general anaesthesia in a cardiac catheterisation laboratory by an structural heart / interventional cardiologist. The
Patients with Heart Failure with preserved or mid range Ejection Fraction (HFpEF) fulfilling the inclusion / exclusion criteria will be treated once with the Alleviant Medical Interatrial Shunt System. This system creates a controlled size interatrial shunt via a proprietary catheter to the atrial septum during one treatment procedure. The therapy is delivered administered under general anaesthesia in a cardiac catheterisation laboratory by an structural heart / interventional cardiologist. The procedure will take approximately one to two hours. Efficacy is measured intra-procedurally by detection of the shunt determined by trans esophageal echocardiography (TEE) or Intra-Cardiac Echo (ICE).
Sponsors
Alleviant Medical Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Candidates for the study must meet all of the following inclusion criteria at screening: 1. Documented history of NYHA Class II, Class III or ambulatory Class IV at the screening visit. 2. History of at least one hospitalization for treatment of heart failure within the past 12 months. 3. LVEF greater than or equal to 40% as measured by the study-specific transthoracic echocardiography. 4. Echocardiographic evidence of diastolic dysfunction documented by one or more of the following as measured by the study-specific transthoracic echocardiography protocol performed during screening: - LA diameter greater than 4 cm - LA volume index greater than 28 mL - Lateral e’ less than 10 cm/s - Septal e’ less than 8 cm/s - Lateral E/e’ greater than 10 - Septal E/e’ greater than 15 5. Elevated left atrial pressure WITH a gradient compared to right atrial pressure (RAP) documented by: (1) end-expiratory PCWP at peak supine cycle ergometer exercise greater than or equa. to 25 mmHg AND (2) PCWP greater than RAP by greater than or equal to 5 mmHg, OR greater than or equal to 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND PCWP greater than RAP by greater than or equal to 5 mmHg.
Exclusion criteria
Candidates for the study must be free of all of the following exclusion criteria at screening: 1. Presence of advanced heart failure defined as one or more of the following: - ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF. - Cardiac index less than 2.0 L/min/m2. - Patient is on the cardiac transplant waiting list. - Inotropic infusion (continuous or intermittent) for EF less than 40% within the past 6 months. 2. Presence of moderate or worse valve disease, defined as one or more of the following: - Moderate or worse mitral valve regurgitation or moderate or worse mitral stenosis. - Moderate or worse tricuspid valve regurgitation. - Moderate or worse aortic valve disease defined as moderate or worse AS or AI. 3. . Presence of chronic pulmonary disease defined by one or more of the following: - Requirement for continuous home oxygen use. - Hospitalization within the past 12 months for treatment of pulmonary disease. - Significant chronic pulmonary disease defined as FEV1 less than 50%. 4. Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2 5. 6-minute walk distance less than 50 m or greater than 450 m performed during screening. 6. Documented atrial fibrillation with ventricular rate greater than 100 BPM at screening. 7. Presence of moderate or worse right heart dysfunction OR RV dysfunction defined as TAPSE less than 14 mm or RVFAC less than or equal to 30% 8. Presence of pulmonary hypertension with PASP greater than or equal to 70 mmHg OR PVR greater than 4 Wood units. 9. Presence of anatomic anomaly that precludes creation of interatrial shunt (including patent foramen ovale, atrial septal defect, target septal thickness greater than 3 mm) 10. SBP greater than 170 mmHg at screening. 11. Documented left ventricular end diastolic diameter greater than 6 cm.
Outcome results
None listed