Alleviate-HF-1 Study

NCT04583527 | Completed Phase 1

• 1 other identifier: CIP-0001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (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.

  At one month

Interventions

ALV1 System 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:

• Documented history of NYHA Class II, Class III or ambulatory Class IV at the screening visit.
• History of at least one hospitalization for treatment of heart failure within the past 12 months.
• LVEF greater than 40% as measured by the study-specific transthoracic echocardiography.
• Echocardiographic evidence of diastolic dysfunction documented by one or more of the following as measured by the study-specific transthoracic echocardiography protocol performed during screening:
• LA diameter greater than 4 cm
• LA volume index greater than 28 mL
• Lateral e' less than 10 cm/s
• Septal e' less than 8 cm/s
• Lateral E/e' greater than 10
• Septal E/e' greater than 15
• 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 greater than or equa. to 25 mmHg AND (2) PCWP greater than RAP by greater than or equal to 5 mmHg, OR greater than or equal to 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND PCWP greater than RAP by greater than or equal to 5 mmHg.

You may not qualify if:

• 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.
• 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.
• Presence of chronic pulmonary disease defined by one or more of the following:
• Requirement for continuous home oxygen use.
• Hospitalization within the past 12 months for treatment of pulmonary disease.
• Significant chronic pulmonary disease defined as FEV1 less than 50%.
• Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2
• minute walk distance less than 50 m or greater than 450 m performed during screening.

Sponsors & Collaborators

• Alleviant Medical, Inc.: lead

Study Sites (1)

Tbilisi Heart & 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: September 9, 2020
• First Posted: October 12, 2020
• Study Start: August 11, 2020
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

GE (1)