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Can a Dual-Chamber heart pump save the failing heart?

NCT ID NCT07757451

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial is testing a new mechanical heart pump called the DuoCor 2, designed to support both sides of the heart in people with advanced heart failure. The study will enroll 64 patients who are severely ill and need circulatory support. The main goal is to see if the device helps patients survive without major complications for at least six months, with follow-up for up to two years. The trial also measures improvements in patients' ability to walk and their overall heart function.

What this could mean

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

Active substance
DuoCor 2 Ventricular Assist System (a mechanical heart pump implanted to support both sides of the heart)
What this could lead to
If successful, this device could offer a new lifeline for people with advanced heart failure, potentially improving survival and quality of life while waiting for a transplant or as a long-term support.
What could go wrong
This is an early-stage, single-arm study with a small number of participants. The device is invasive and carries risks like bleeding, infection, or device malfunction. Success is not guaranteed, and results may not apply to all patients.

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 64 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

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 75 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: * 1.18 years ≤ Age ≤ 75 years * 2.INTERMACS Class 1-2 * 3.Patient is inotrope dependent, OR has a Cardiac Index (CI) \< 2.2 L/min/m2, while not on inotropes * 4\. Patient has reduced exercise capacity due to cardiac factors with at least one of the following criteria: * Unable to exercise * 6-minute walking test (6MWT) \< 300 meters * 5.Patient has right heart failure related symptoms such as lower limbs edema, jugular vein distension * 6.Patient has advanced, irreversible biventricular heart failure and is deemed to be eligible for biventricular mechanical circulatory support by clinical expertise. * 6a: advanced left heart failure * Left ventricular ejection fraction (LVEF) ≤ 30%; * Pulmonary capillary wedge pressure (PCWP) \> 15mmHg. * 6b: severe right heart failure despite guideline-directed medical therapy. This includes at least one evaluation index of right ventricular function and at least one evaluation index of volume load or structural abnormality: * Evaluation index of right ventricular function: * Right ventricular ejection fraction (RVEF)≤ 30%; * Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg\*L/m2; * Right ventricle fractional area change(RVFAC) \< 30%; * Evaluation index of volume load or structural abnormality: * Central venous pressure (CVP)\> 15 mmHg; * CVP to PCWP ratio\> 0.63; * Moderate to severe tricuspid regurgitation; * Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio\> 0.72; * Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm; * Pulmonary artery pressure index (PAPi)\< 2. * 7.Patient or its legal representative has signed the informed consent, has full understanding of procedures and the study, and is committed to following study requirements. Exclusion Criteria: * 1.Known intolerance to anticoagulant or antiplatelet therapies. * 2.Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis /senile or other infiltrative heart disease) * 3.Coagulopathy defined by platelets \< 100\*10\^9/L or INR ≥ 1.5 not due to anticoagulant therapy. * 4\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. * 5\. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days. * 6\. Presence of ECMO with a duration greater than 10 days. * 7.Moderate to severe aortic valve regurgitation or pulmonary valve regurgitation, and refusal of bioprosthetic valve replacement. * 8.Presence of mechanical aortic valve or pulmonary valve, and refusal of bioprosthetic valve replace. * 9\. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device. * 10\. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation. * 11\. Presence of significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration. * 12\. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: * Total bilirubin \> 3.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy; * Glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 or renal replacement therapy dependence; * History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC \< 0.7, and FEV1 \< 50% predicted. * 13\. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units. * 14\. Severe systemic light-chain amyloidosis. * 15\. Blood stream infection within 7 days. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion. * 16\. Sepsis * 17\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter. * 18.Any condition other than HF that could limit survival to less than 24 months. * 19.Positive pregnancy test if of childbearing potential, lactating mothers. * 20.Presence of psychiatric disorders, irreversible cognitive impairment, or psychosocial issues that may compromise their ability to comply with the study protocol and management requirements for implantable ventricular assist devices, or brain death due to any cause. * 21\. Participation in any other clinical investigation that is likely to confound study results or affect the study. * 22.Ineligibly based on physician's judgement due to other severe conditions or other conditions which can interfere with subject's compliance to the study.

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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.

How to take part

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

  1. The places running it

    1 site. 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

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430000, China

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