ALLEVIATE-HF-HD Study

NCT05501652 | Completed Phase 1

• 1 other identifier: CIP-0005
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF 25-39%), or mid-range left ventricular ejection fraction (HFmrEF, EF 40-49%), or preserved left ventricular ejection fraction (HFpEF, 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Primary Safety 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.

  1-Month

• Primary Efficacy Endpoint

  Change in supine exercise PCWP at 25-watts exercise from baseline to Month 1.

  1-Month

Interventions

ALV1System DEVICE

The ALV1 system is designed to create a controlled size interatrial shunt via a proprietary intra-cardiac catheter. There is no temporary or permanent implant used to create or maintain the interatrial shunt. The therapy is intended to be delivered in a single procedure administered under general anesthesia in a cardiac catheterization laboratory.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NYHA class II if a prior history of \> NYHA class II; OR NYHA class III; OR ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit.
• Within 12 months of study entry: ≥ 1 HF hospital admission (with HF as the primary or secondary diagnosis); OR treatment with IV diuretics; OR an NT-pro BNP value \> 150 pg/ml in normal sinus rhythm, \> 450 pg/ml in atrial fibrillation, or a BNP value \> 50 pg/ml in normal sinus rhythm, \> 150 pg/ml in atrial fibrillation within the past 6 months.
• Site determined echocardiographic LVEF \> 25% as measured by the study specific screening transthoracic echo.
• Site determined hemodynamic criteria assessed by the screening supine bicycle exercise right heart catheterization test, including each of the components (a)-(b) below:
• a. At rest: i. RAP \< 14 mmHg ii. PVR \< 3.5 Wood units iii. PAS \< 70 mmHg iv. Cardiac Index \> 1.9 L/min b. At exercise (25-watts): i. PCWP must have a gradient \> 5 mmHg of the RA ii. End-expiratory PCWP ≥ 25 mmHg iii. PVR \< 1.8 Wood units \[if PVR cannot be obtained (e.g., patient stopped pedaling), TPG \< 12 mmHg\]

You may not qualify if:

• 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 \< 2.0 L/min/m2
• Inotropic infusion (continuous or intermittent) for EF \< 40% within the past 6 months
• Patient is on the cardiac transplant waiting list.
• Presence of uncorrected valve disease documented in the medical history and/or confirmed by the study-specific TTE protocol performed during screening, defined as one or more of the following:
• Greater than moderate mitral regurgitation
• Greater than moderate mitral stenosis
• Greater than mild tricuspid regurgitation
• Greater than moderate aortic stenosis
• Greater than moderate aortic regurgitation
• Presence of clinically significant untreated carotid artery stenosis documented in the medical history that is likely to require intervention.
• Presence of clinically significant un-revascularized coronary artery disease documented in the medical history that is likely to require intervention, defined as epicardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
• Presence of hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy such as hemochromatosis or sarcoidosis.
• Presence of uncontrolled tachyarrhythmia documented in the medical history.

Sponsors & Collaborators

• Alleviant Medical, Inc.: lead

Study Sites (1)

Tbilisi Heart and Vascular

Tbilisi, Georgia

Location

Related Publications (1)

• Laufer-Perl M, Flint N, Arbel Y, Alenezi F, Kittipibul V, Yaranov D, Shaburishvili T, Amin R, Fudim M. Atrial Mechanics in Heart Failure With Preserved Ejection Fraction: Effect of a No-Implant Interatrial Shunt. Circ Heart Fail. 2025 Oct;18(10):e012573. doi: 10.1161/CIRCHEARTFAILURE.124.012573. Epub 2025 Sep 3.

  PMID: 40899260 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 15, 2022
• Study Start: June 30, 2022
• Primary Completion: August 22, 2022
• Study Completion: February 3, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

GE (1)