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Heart pump combo tested for shock recovery – trial cut short

NCT ID NCT03431467

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding an Impella CP heart pump early to standard VA-ECMO support helps people recover from cardiogenic shock, a life-threatening condition where the heart can't pump enough blood. The trial planned to enroll adults with severe heart failure but was terminated early after only 17 participants. Researchers measured survival without needing long-term heart support, transplant, or IV medications at 30 days.

What this could mean

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

Active substance
Impella CP (a heart pump device)
What this could lead to
If successful, this approach could improve heart recovery and reduce the need for long-term heart support or transplant in people with severe heart failure.
What could go wrong
The trial was terminated early with only 17 participants, so results are very limited. Adding a second device also increases 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

17 people

The number who actually took part.

Started

Mar 2018

Finished

Sep 2023

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

18 to 65 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: * Cardiogenic shock: Including refractory to conventional therapy, including systolic blood pressure \< 90mm Hg, Cardiac Index \< 1.8 or a cardiac index \< 2.0 on moderate to high doses of inotropes and vasopressors for greater than 30 mins, or systemic signs of tissue hypoxia. * Post-acute myocardial infarction cardiogenic shock: excluding mechanical complications requiring surgical intervention after extracorpeal membrane oxygenator (ECMO) such as post-ischaemic ventricular septal defect (VSD). * Drug overdose-induced cardiogenic shock. * Early graft failure: post orthotropic heart transplantation cardiogenic shock, excluding immediate intra-operative failure. * Acute on chronic cardiomyopathy with progressive shock and decompensation unresponsive to medical therapies. Exclusion Criteria: * Recent Significant Pulmonary Embolus * Moderate to severe aortic valve insufficiency (AI) * Ongoing significant sepsis * Severe pulmonary hypertension \& shock * Hypothermia * Post-cardiotomy cardiogenic shock * Continuous cardiopulmonary resuscitation (CPR) \>20-30 minutes, except if neurological status is satisfactory * Transfer from outside hospital on VA ECMO or with history of CPR * Listed for cardiopulmonary transplantation or being evaluated for cardiopulmonary transplantation or permanent mechanical circulatory support * Known or suspected chronic heart failure with echocardiogram documenting left ventricular diastolic diameter \>6.5cm * Known or suspected chronic heart failure with echocardiogram documenting left ventricular ejection fraction \< 25% * Mechanical aortic valve replacement * Presence of left ventricular thrombus * Pre-existing Impella 2.5, CP, 3.5 or 5.0 * Cardiogenic shock due to primary respiratory failure * Mechanical complications requiring surgical intervention after ECMO such as post-ischaemic VSD. * Severe liver failure * Active malignancy * Acute aortic dissection * Intracranial hemorrhage * Neurological injury including recent cerebrovascular accident or suspected severe neurologic injury

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hospital of The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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