ALLEVIATE-HFrEF Study

NCT05133089 | Completed Phase 1

• 1 other identifier: CIP-0004
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

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.

  1-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:

• 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.

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 \<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.
• Severe functional mitral regurgitation.
• Moderate or worse tricuspid valve regurgitation.
• Moderate or worse aortic valve disease defined as moderate or worse aortic stenosis.
• Severe 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 frequent angina not well controlled with medical therapy or other evidence of coronary ischemia.
• Presence of infiltrative or hypertrophic cardiomyopathy documented in the medical history.

Sponsors & Collaborators

• Alleviant Medical, Inc.: lead

Study Sites (1)

Tbilisi Heart & Vascular

Tbilisi, Georgia

Location

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: November 12, 2021
• First Posted: November 24, 2021
• Study Start: August 10, 2021
• Primary Completion: March 10, 2022
• Study Completion: June 1, 2022
• Last Updated: July 18, 2023

Record last verified: 2022-07

Locations

GE (1)