Alleviate-HF-2 Study

NCT04838353 | Completed

• 1 other identifier: CIP-0002
• Study Type: interventional
• Target: 13
• Locations: 4 countries
• Sites: 5

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 major adverse cardiac, cerebrovascular and thromboembolic events and change in supine exercise PCWP at peak exercise.

  Defined as cardiovascular death, embolic stroke, embolic myocardial infarction, pulmonary or arterial embolism, device-and/or procedure-related serious adverse cardiac events.

  At 1 month and through 12 months

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:

• 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..
• LVEF (by Echo) \> 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:
• LA diameter \> 4cm
• LA volume index \>28 mL
• Lateral e' \<10 cm/s
• Septal e' \<8 cm/s
• Lateral E/e' \>10
• Septal E/e' \>15
• As measured by the study-specific exercise hemodynamic right heart catheterization protocol performed during screening: 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.

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 (5)

Flinders Medical Centre

Adelaide, Australia

Location

Monash Medical Centre

Clayton, Australia

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Canada

Location

Southern District Health Board

Dunedin, New Zealand

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (2)

• 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

• Udelson JE, Barker CM, Wilkins G, Wilkins B, Gooley R, Lockwood S, Potter BJ, Meduri CU, Fail PS, Solet DJ, Feldt K, Kriegel JM, Shaburishvili T. No-Implant Interatrial Shunt for HFpEF: 6-Month Outcomes From Multicenter Pilot Feasibility Studies. JACC Heart Fail. 2023 Aug;11(8 Pt 2):1121-1130. doi: 10.1016/j.jchf.2023.01.024. Epub 2023 Apr 26.

  PMID: 37115132 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 9, 2021
• Study Start: April 3, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 31, 2023
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

AU (2); CA (1); NZ (1); SE (1)