Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New heart pump could save lives after surgery shock

NCT ID NCT07560085

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study tests a new device called SynFlow Duro, a temporary heart pump for people who go into severe shock after heart surgery. About 60 adults in China will receive the pump to see if it helps their heart recover or keeps them stable until a transplant or permanent device. The goal is to improve survival and reduce the need for other emergency support.

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 60 people

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

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

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 80 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: * 18≤Age≤80, any sex. * Failure to wean from CPB or refractory cardiogenic shock after cardiac surgery. Failure to wean from CPB is defined as failed to discontinue CPB or post-weaning CI \<2.2L/min/m2 + PCWP \>15mmHg, despite optimal pre-weaning management and receiving at least one high dose inotrope. Refractory cardiogenic shock is defined as a condition that occurs despite adequate fluid status and meets all the following criteria: ① CI\<2.2L/min/m2 + PCWP\>15mmHg despite receiving at least one high dose inotrope or IABP; OR SBP \<80mmHg or MAP\<50mmHg despite receiving at least one high dose intrope + high dose norepinephrine or IABP. ② Presence of at least one signs indicating hypoperfusion: decreased mentation; cold, clammy, ashen or cyanotic extremities or skin or livedo reticularis; urine output\<30ml/h or 0.5ml/kg/h; or lactate\>2mmol/L or metabolic acidosis. \- Patient has signed the informed consent form. Exclusion Criteria: * Body surface area\>2.5m2. * Presence of any cardiac assist device (other than an IABP). * Right ventricular failure. * Evidence of any vascular disease or anatomy precluding placement or deployment of the device (e.g. severely calcified vessel). * Evidence of ventricular thrombus. * Moderate or severe aortic valve insufficiency/stenosis, or severe aortic valve calcification. * Presence of mechanical aortic valve or cardiac contractile device. * Obstructive, hypertrophic cardiomyopathy. * Presence of uncorrected ventricular septal defect, atrial septal defect or patent foramen ovale. * Mechanical manifestation of AMI (e.g. ventricular septal rupture, papillary muscle rupture, ventricular rupture). * Any hematological disorder causing fragility of blood vessel or hemolysis. * Known allergy or intolerant to heparin. * Presence or suspicion of active systemic infection. * Cardiopulmonary resuscitative maneuver lasting longer than 20 minutes before device placement. * Sustained or non-sustained ventricular tachycardia or ventricular fibrillation unresponsive to medical therapy. * Severe hepatic dysfunction, renal failure or severe respiratory failure * Pregnant or lactating female. * Concomitant enrollment in another investigational drug or device study where the primary endpoint has not yet been completed or that will clinically interfere with the endpoint of this investigation. * Other conditions considered unsuitable for participating in this investigation by the investigators.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cardiogenic shock are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cardiogenic shock Shock, Cardiogenic

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 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

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Zhongnan Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, China

More trials for these conditions

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