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Heart pump patients: does routine leg tube prevent limb loss?

NCT ID NCT07482865

Disease control Sponsor: Samsung Medical Center 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether routinely placing a small tube in the leg artery (distal perfusion catheter) is better than waiting until a problem arises in patients on mechanical heart pumps. About 500 adults with severe heart failure or shock will be randomly assigned to one of the two approaches. The main goal is to see which strategy reduces the risk of serious leg complications.

What this could mean

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

Active substance
Distal perfusion catheter insertion (a small tube placed in the leg artery to keep blood flowing)
What this could lead to
If routine placement works better, it could become standard practice to prevent leg complications in patients on heart pumps.
What could go wrong
This is an early-stage trial (not yet recruiting) with no phase assigned, so results are uncertain. The procedure itself carries risks like bleeding or infection.

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

About 500 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

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.

Ages

19 years and older

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: * Patients aged 19 years old * Cardiogenic shock requiring mechanical circulatory support through femoral artery approach * Subject who can verbally confirm understandings of risks and benefits of receiving distal perfusion catheter insertion and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * Under the critically-ill clinical circumstance (unclear consciousness of patient), legally authorized representative can provide written informed consent prior to any study related procedure. Exclusion Criteria: * Apparent symptoms and sign of acute limb ischemia immediately after mechanical circulatory support insertion * Significant coagulopathy precluding invasive procedure due to high risk of bleeding * Pregnant women, women with potential childbearing, or lactating women * Irreversible limb ischemia requiring interventional procedures or surgery at the time of MCS insertion * Previous history if femoral-femoral bypass grafting or femoral-popliteal bypass grafting * Previous history of limb amputation * Unwilling or unable to obtain informed consent from the participant or legally authorized representative

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Conditions

The condition(s) this trial relates to.

cardiogenic shock congestive heart failure heart failure inferior myocardial infarction limb ischemia myocarditis Shock, Cardiogenic

As listed by the trial registrant

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

Acute limb ischemia Acute myocardial infarction of inferior wall Cardiogenic shock Congestive heart failure Myocarditis

How to take part

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

  1. The places running it

    6 sites. 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

  • Eunpyeong St. Mary's Hospital

    Seoul, South Korea

  • Gyeongsang National University Changwon Hospital

    Changwon, South Korea

  • Korea University Anam Hospital

    Seoul, South Korea

  • Kwandong University Intl. ST. Mary's Hospital

    Incheon, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Samsung Medical Center Changwon Hospital

    Changwon, South Korea

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