Evaluation of the Safety and Effectiveness 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.5 sites in 4 countries13 target enrollmentApril 3, 2021

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Alleviant Medical, Inc.
Enrollment: 13
Locations: 5
Primary Endpoint: The composite incidence of one or more major adverse cardiac, cerebrovascular and thromboembolic events and change in supine exercise PCWP at peak exercise.
Status: Completed
Last Updated: last year

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

April 3, 2021

End Date

December 31, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alleviant Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit.
•Medical history within the past 12 months of at least one hospitalization with heart failure as the primary or secondary diagnosis OR treatment with IV diuretics for heart failure..
•LVEF (by Echo) \> 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:
•LA diameter \> 4cm
•LA volume index \>28 mL
•Lateral e' \<10 cm/s
•Septal e' \<8 cm/s
•Lateral E/e' \>10
•Septal E/e' \>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 major adverse cardiac, cerebrovascular and thromboembolic events and change in supine exercise PCWP at peak exercise.

Time Frame: At 1 month and through 12 months

Defined as cardiovascular death, embolic stroke, embolic myocardial infarction, pulmonary or arterial embolism, device-and/or procedure-related serious adverse cardiac events.