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New heart pump aims to make risky angioplasty safer

NCT ID NCT07675005

Disease control Sponsor: Life Shield Medical Technology Co., LTD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This trial compares a new temporary heart pump called VentriCure with standard ECMO support in people with coronary artery disease undergoing high-risk angioplasty. The study includes 220 patients whose hearts are weak or who have severe heart failure. The goal is to see if VentriCure reduces major complications like death, heart attack, stroke, or major bleeding within 30 days after the procedure.

What this could mean

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

Active substance
VentriCure left ventricular assist system (a temporary heart pump)
What this could lead to
If successful, VentriCure could offer a safer, more effective way to support the heart during high-risk angioplasty, reducing complications compared to ECMO.
What could go wrong
This is an early-stage device trial with 220 participants. The device may not prove safer or more effective than ECMO, and risks include bleeding, stroke, or heart damage.

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 220 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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

18 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: 1. Patient age ≥18 years old; 2. As assessed by the cardiac team the patient needs coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is of high risk, or the patient refuses to undergo CABG; 3. The patient is meeting one of the following: (1) Coronary Artery Disease and left ventricular ejection fraction ≤35%; (2) Coronary Artery Disease and left ventricular ejection fraction ≤40% and severe heart failure; 4. PCI was required for imaging diagnosis; 5. Patient willing and able to comply with protocol requirements and accept clinical follow-up; able to understand study purpose and sign informed consent. Exclusion Criteria: 1. Cardiac arrest within 24 hours; 2. The implantation of an interventional left ventricular assist system was either contraindicated or not feasible; 3. ST-segment elevation myocardial infarction (STEMI) within 24 hours; 4. Chronic Kidney Disease; 5. Severe right heart failure or severe tricuspid regurgitation; 6. Presence of abnormal coagulation parameters (platelet count ≤75,000/mm\^3, INR≥2.0, or fibrinogen ≤1.50g/L); 7. Moderate or higher anemia; 8. History of stroke or transient ischemic attack (TIA) within one month; 9. Allergy or intolerance to anticoagulants or contrast agent; 10. Active internal bleeding within a month; 11. Presence of uncontrolled active infection; 12. Pregnant or lactating women; 13. Patients are participating in other clinical trials; 14. Other circumstances that are determined by the investigator to be unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

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