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Can a heart pump spark its own recovery? a new study investigates

NCT ID NCT06800716

Knowledge-focused Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This observational study looks at how the heart recovers in people with severe heart failure who are supported by the Impella 5.5, a temporary heart pump, while waiting for a transplant. Researchers will track changes in heart function and size, as well as blood and tissue markers, over about 14 months. The goal is to understand which patients might recover enough to avoid a transplant. Participants will undergo standard tests like echocardiograms and a six-minute walk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Impella 5.5 left ventricular assist device (LVAD)
What this could lead to
If successful, this could help identify which patients might recover heart function without needing a transplant, potentially guiding future treatment decisions.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The findings may not apply to all heart failure patients, and the small size limits generalizability.

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.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Inpatients at Columbia University Irving Medical Center, who are waitlisted for heart transplant with a clinical indication for Impella 5.5 left ventricular assist device (LVAD) placement.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age 18 years or older * Dilated cardiomyopathy (LVEDD \> 5.5 cm and LVEF \<25%) * Indication for temporary mechanical circulatory support therapy with Impella 5.5 LVAD as a bridge to transplant or bridge to transplant decision based on treating physician's discretion Exclusion Criteria: * Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation * Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation * Congenital heart disease * Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis * Evidence of acute myocarditis by endomyocardial biopsy * Prior heart transplantation * Mechanical aortic / mitral valve * Patient with known aortic diseases such as Marfan-Syndrome, Morbus Erdheim-Gsell or others * Left Ventricular thrombus * Left Ventricular rupture * Cardiac tamponade * Presence of an Atrial or Ventricular Septal Defect * Severe right ventricular (RV) Failure requiring mechanical RV support * Severe peripheral vascular disease precluding placement of the Impella System * Recent stroke resulting in significant neurological deficit * Hypercoagulable disease precluding device implantation * Severe thrombocytopenia (\<50,000) * Contraindication to anticoagulation * Suspected or known pregnancy or lactating women * Subject belongs to a vulnerable population

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Conditions

The condition(s) this trial relates to.

cardiomyopathy dilated cardiomyopathy heart failure Shock, Cardiogenic

As listed by the trial registrant

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

Cardiomyopathy Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

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