Alleviant Device for Heart Failure

Enrolling by invitation at 114 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Alleviant ALV1 System, designed to assist individuals with a specific type of heart failure. The trial aims to determine if creating a small opening between heart chambers can improve symptoms related to heart failure with preserved or mid-range ejection fraction, which measures how well the heart pumps blood. Participants will receive either the actual device procedure or a sham (fake) procedure for comparison. Individuals experiencing heart failure symptoms with a left ventricular ejection fraction of 40% or higher might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to innovative heart failure treatments.

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 prior data suggests that the Alleviant ALV1 System is safe for heart failure patients?

Research has shown that the Alleviant ALV1 System, which creates a small opening between the heart's upper chambers, has undergone safety testing in people with heart failure. In one study, most patients handled the treatment well, experiencing only a few serious side effects. Most had mild or moderate issues, such as temporary discomfort at the procedure site.

The trial's "Not Applicable" phase indicates less safety data than later stages. However, early results suggest promising safety outcomes in humans. The treatment continues to be carefully monitored to ensure its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Alleviant ALV1 System is unique because it offers a minimally invasive approach to treating heart failure, unlike traditional options such as medication, lifestyle changes, or more invasive surgeries like valve repair or replacement. This device is designed to relieve pressure in the heart by creating a small opening in the wall between the heart's upper chambers, which can help improve symptoms and quality of life. Researchers are excited about this treatment because it targets heart function directly, potentially offering quicker symptom relief and reducing the need for more invasive interventions.

What evidence suggests that the Alleviant ALV1 System is effective for heart failure?

Research shows that the Alleviant ALV1 System, which participants in this trial may receive, is designed to help people with heart failure by creating a small opening between the heart's upper chambers. This reduces pressure and strain on the heart's left side. Studies have found that devices like this can improve symptoms and increase exercise ability for people with certain types of heart failure. Six-month results from similar devices showed promising improvements in easing heart failure symptoms. These findings suggest that the Alleviant ALV1 System could effectively manage heart failure. Participants in the control arm of this trial will undergo a sham procedure for comparison. ^{1 2 3 4 5}

Who Is on the Research Team?

James Udelson, MD

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

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 pulmonary vascular resistance during exercise is less than 1.8 Wood Units.

Exclusion Criteria

My condition is advanced heart failure.

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

You have a pacemaker.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06812533

Study Details | NCT06812533 | Alleviant ALLAY-HFrEF Study Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy ...

2. withpower.com withpower.com/trial/phase-heart-failure-1-2023-9d5dd

Alleviant Device for Heart Failure · Info for Participants 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 ...

3. jacc.org jacc.org/doi/10.1016/j.jchf.2023.01.024

No-Implant Interatrial Shunt for HFpEF: 6-Month Outcomes ... The goal of this study was to investigate the safety and efficacy of a no-implant interatrial shunt for patients with heart failure with preserved ejection ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/alleviant-medical-secures-90m-to-launch-pivotal-aortic-stent-trial/

Alleviant Medical secures $90m to launch pivotal aortic ... Alleviant Medical has secured $90m to fund a second pivotal trial of the company's heart system for patients living with heart failure and reduced ejection ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05685303

Study Details | NCT05685303 | Alleviant ALLAY-HF Study Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously ...