Alleviant Device for Heart Failure

Recruiting at 101 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alleviant Medical, Inc.

Must be taking: GDMT

Disqualifiers: Advanced heart failure, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Procedure day

500 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have ongoing stable GDMT (guideline-directed medical therapy), which suggests you may need to continue your current heart failure treatments.

What data supports the effectiveness of the Alleviant ALV1 System treatment for heart failure?

The research on left ventricular assist devices (LVADs) shows that they can improve survival and quality of life in patients with advanced heart failure. These devices help the heart pump blood more effectively, which can reduce symptoms and improve daily functioning. ^{1 2 3 4 5}

How is the Alleviant ALV1 System treatment different from other heart failure treatments?

The Alleviant ALV1 System is unique because it is a device designed to assist the heart by reducing the pressure and workload on the left ventricle, which can improve heart function and oxygen use. Unlike traditional drug treatments, this system is a mechanical support that can be implanted to provide long-term assistance for patients with severe heart failure. ^{2 3 6 7 8}

Research Team

James Udelson, MD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

This trial is for people with heart failure who can still move around (NYHA Class II, III or ambulatory IV) and have a specific type of heart function (LVEF ≥ 40%). They must show high pressure in the left part of their heart during exercise and not have advanced heart failure, pacemakers, or right heart issues.

Inclusion Criteria

I am on a stable heart or blood pressure medication regimen.

I have mild to moderate heart condition but can still move around.

Your heart pressure is too high during exercise testing.

Exclusion Criteria

My condition is advanced heart failure.

You have a pacemaker.

There are signs of problems with the right side of your heart.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo cardiac imaging, femoral vein access, and receive the Alleviant ALV1 System device procedure

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of mortality, heart failure events, and quality of life

12 months

Treatment Details

Interventions

• Alleviant ALV1 System
• Sham-Control

Trial Overview The study tests the Alleviant ALV1 System—a device to create a small channel between the left and right sides of the heart—against a sham procedure. Participants won't know which they receive in this controlled comparison to see if it's safe and helps symptoms.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.

Group II: Control Placebo Group 1 Intervention

Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.

Who Is Running the Clinical Trial?

Alleviant Medical, Inc.

Lead Sponsor

Trials

5

Recruited

540+

Findings from Research

In the ROADMAP study, patients with advanced heart failure who received a left ventricular assist device (LVAD) showed significant improvements in health-related quality of life (hrQoL) compared to those receiving optimal medical management, particularly in patients with low baseline quality of life scores (VAS < 55).

Patients with low baseline hrQoL (VAS < 55) had better survival rates on LVAD therapy (82%) compared to those on optimal medical management (58%), highlighting the importance of assessing hrQoL when considering LVAD implantation for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Health-Related Quality of Life Is a Predictor of Outcomes in Ambulatory Heart Failure Patients Treated With Left Ventricular Assist Device Compared With Medical Management: Results From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management). Stehlik, J., Estep, JD., Selzman, CH., et al.[2018]

The HeartCon left ventricular assist device (LVAD) significantly improved heart function and quality of life in 20 adult patients with end-stage heart failure, as evidenced by reductions in left ventricular end-diastolic diameter and increases in left ventricular ejection fraction after 90 days.

The procedure was safe, with no mechanical failures reported and a low incidence of serious complications, although further studies are needed to assess long-term effects and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Short-term effect of HeartCon left ventricular assist device on the treatment of 20 adult patients with end-stage heart failure]. Wang, W., Song, Y., Zhang, Y., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Health-Related Quality of Life Is a Predictor of Outcomes in Ambulatory Heart Failure Patients Treated With Left Ventricular Assist Device Compared With Medical Management: Results From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management). [2018]

2. China pubmed.ncbi.nlm.nih.gov

[Short-term effect of HeartCon left ventricular assist device on the treatment of 20 adult patients with end-stage heart failure]. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Chronic evaluations of ventricular ejection phase dynamics during abdominal left ventricular assist device (ALVAD) pumping in the awake, unanesthetized calf. [2007]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Therapeutic options in advanced heart failure : place of durable left ventricular assist device (LVAD)]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Newer mechanical devices in the management of acute heart failure. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Development and evaluation of electrically actuated abdominal left ventricular assist systems for long-term use. [2007]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Adjustable model of chronic left ventricular dysfunction. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Polymer-based restoration of left ventricular mechanics. [2018]