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Vein-Blocking device shows promise for heart failure patients

NCT ID NCT03836079

Symptom relief Sponsor: Abiomed Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called preCARDIA that temporarily blocks a large vein in the chest to help patients with sudden, severe heart failure. The goal was to see if it is safe and can help remove excess fluid when standard treatments are not working. The study included 60 adults with advanced heart failure who were not responding well to water pills.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Jul 2019

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * NYHA Class III-IV heart failure * Subjects with inadequate diuresis * Stage C-D systolic heart failure Exclusion Criteria: * Active myocardial ischemia or acute coronary syndrome (ACS) * Severe aortic or mitral valve insufficiency * Severe peripheral vascular disease

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart disorder heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute decompensated heart failure Acute heart failure Congestive heart failure Heart diseases

Contacts and locations

Locations

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Baylor, Scott & White Medical Center - Temple

    Temple, Texas, 76508, United States

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota, 56303, United States

  • Colorado Heart & Vascular

    Lakewood, Colorado, 80226, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Inova Health System

    Falls Church, Virginia, 22042, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Northwestern

    Chicago, Illinois, 60611, United States

  • OhioHealth

    Columbus, Ohio, 43214, United States

  • Providence Health & Services

    Portland, Oregon, 97225, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.