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Device

Alleviant Device for Heart Failure

N/A
Waitlist Available
Led By James Udelson, MD
Research Sponsored by Alleviant Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ongoing stable GDMT
NYHA Class II, III or ambulatory IV
Must not have
Advanced heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month

Summary

This trial studies a device to help people with heart failure caused by stiffening or thickening of the heart.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include discomfort at the insertion site, irregular heartbeat risks due to shunt placement, bleeding complications, or infection. The full range of side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on a stable heart or blood pressure medication regimen.
Select...
I have mild to moderate heart condition but can still move around.
Select...
I have undergone a specific heart test while exercising.
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I have heart failure symptoms with a heart pumping percentage of 40% or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My condition is advanced heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite Primary Endpoint

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
Group II: ControlPlacebo Group1 Intervention
Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.

Find a Location

Who is running the clinical trial?

Alleviant Medical, Inc.Lead Sponsor
4 Previous Clinical Trials
38 Total Patients Enrolled
James Udelson, MDPrincipal InvestigatorTufts Medical Center
2 Previous Clinical Trials
1,051 Total Patients Enrolled

Media Library

Alleviant ALV1 System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05685303 — N/A
Congestive Heart Failure Research Study Groups: Control, Treatment
Congestive Heart Failure Clinical Trial 2023: Alleviant ALV1 System Highlights & Side Effects. Trial Name: NCT05685303 — N/A
Alleviant ALV1 System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05685303 — N/A
~197 spots leftby Apr 2026
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