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Alleviate-HF-2 Study | Clinical Trials | Clareo Health

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Alleviate-HF-2 Study

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

NCT04838353•Alleviant Medical, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. 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..
•3. LVEF (by Echo) \> 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:
•1. LA diameter \> 4cm
•2. LA volume index \>28 mL
•3. Lateral e' \<10 cm/s
•4. Septal e' \<8 cm/s
•5. Lateral E/e' \>10
•6. Septal E/e' \>15
+1 more criteria

Exclusion Criteria

•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:
+11 more criteria

Locations (5)

Flinders Medical Centre

Adelaide, Australia

Monash Medical Centre

Clayton, Australia

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Canada

Southern District Health Board

Dunedin, New Zealand

Karolinska University Hospital

Stockholm, Sweden

Key Dates

Start Date

April 3, 2021

Primary Completion Date

September 1, 2023

Completion Date

December 31, 2023

Last Updated

October 4, 2024

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

ALV1 System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Alleviate-HF-2 Study

Inclusion Criteria

Exclusion Criteria

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

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