Heart pump combo tested for shock recovery – trial cut short
NCT ID NCT03431467
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
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Mar 2018
- Finished
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Sep 2023
- Lead sponsor
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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
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
- Stick-On patch aims to catch dangerous heart decline sooner
- Heart pump timing put to the test in deadly heart attack shock
- A second chance for the heart: can rehab rewrite the story after shock?
- Blood filter may calm the deadly inflammation of cardiogenic shock
- Microscopic blood vessel health may hold key to cardiogenic shock survival
- Can a machine support a failing heart without overworking it?