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 range40 Years

SexALL

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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
✕. 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.

What they're measuring

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

Timeframe: 1-Month

Trial details

NCT IDNCT05133089

SponsorAlleviant Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-10

View on ClinicalTrials.gov More Heart Failure trials