Evaluation of the Safety and Effectiveness of a Percutaneously Created Interatrial Shunt on Heart Failure Symptoms in Patients with Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction

Alleviant Medical Inc.0 sites30 target enrollmentNovember 16, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 16, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

•Candidates for the study must meet all of the following inclusion criteria at
•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

•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.