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

Alleviant Medical, Inc.1 site in 1 country5 target enrollmentAugust 10, 2021

ConditionsHeart Failure

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Alleviant Medical, Inc.
Enrollment: 5
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: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF ≤ 40%) 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 10, 2021

End Date

June 1, 2022

Last Updated

2 years ago

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.
•Calculated LVEF (by Echo) ≤ 40% as measured by the study-specific transthoracic echocardiography.
•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 ≥ 25mmHg AND (2) PCWP greater than RAP by ≥ 5 mmHg, OR (1) ≥ 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND (2) PCWP greater than RAP by ≥ 5 mmHg. Patients must also have PCWP greater than RAP by ≥ 5 mmHg at rest.

Exclusion Criteria

•Presence of advanced heart failure documented in the medical history, defined as one or more of the following:
•ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF.
•Cardiac index \<1.5 L/min/m
•Patient is on the cardiac transplant waiting list. CIP-0004 Rev 01 - ALLEVIATE-HFrEF Study Confidential Alleviant Medical, Inc. Page 9 of 64
•Inotropic infusion (continuous or intermittent) for EF \< 40% within the past 6 months.
•History of mechanical cardiac support within 6 months.
•Presence of moderate or worse uncorrected valve disease documented in the medical history and/or confirmed by the study-specific transthoracic echocardiography protocol performed during screening, defined as one or more of the following:
•Moderate or worse degenerative mitral valve regurgitation or moderate or worse mitral stenosis.
•Severe functional mitral regurgitation.
•Moderate or worse tricuspid valve regurgitation.

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: 1-Month