Evaluation of the Safety and Feasibility of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction

Alleviant Medical, Inc.1 site in 1 country15 target enrollmentAugust 11, 2020

ConditionsHeart Failure

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Alleviant Medical, Inc.
Enrollment: 15
Locations: 1
Primary Endpoint: The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Patients with heart failure and preserved left ventricular ejection fraction (HFpEF, EF ≥ 50%) or mid-range left ventricular ejection fraction (HFmrEF, 40% < EF < 50%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data.

Registry

clinicaltrials.gov

Start Date

August 11, 2020

End Date

August 16, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alleviant Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Documented history of NYHA Class II, Class III or ambulatory Class IV at the screening visit.
•History of at least one hospitalization for treatment of heart failure within the past 12 months.
•LVEF greater than 40% as measured by the study-specific transthoracic echocardiography.
•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

Exclusion Criteria

•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/m
•Patient is on the cardiac transplant waiting list.
•Inotropic infusion (continuous or intermittent) for EF less than 40% within the past 6 months.
•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.
•. Presence of chronic pulmonary disease defined by one or more of the following:

Outcomes

Primary Outcomes

The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events.

Time Frame: At one month