ALLEVIATE-HFrEF Study (NCT05133089) | Clinical Trial Compass
CompletedPhase 1
ALLEVIATE-HFrEF Study
Georgia5 participantsStarted 2021-08-10
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/m2.
. Patient is on the cardiac transplant waiting list. CIP-0004 Rev 01 - ALLEVIATE-HFrEF Study Confidential Alleviant Medical, Inc. Page 9 of 64
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events.
. 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.