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New dual heart pump offers hope for patients with End-Stage heart failure

NCT ID NCT07233876

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new device called DuoCor 2, which is a mechanical pump that helps both sides of the heart pump blood. It is for people with advanced heart failure in both ventricles who have few other options. The study will enroll 50 adults and measure how many survive for 6 months, either with the device, after a transplant, or after heart recovery.

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 50 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

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\. Age ≥ 18 years and ≤ 75 years * 2\. Patient is inotrope dependent, OR has a Cardiac Index (CI) \< 2.2 L/min/m2, while not on inotropes * 3\. Patient has left heart failure with at least one of the following criteria: * Left ventricular ejection fiction (LVEF) ≤ 30%; * Pulmonary capillary wedge pressure (PCWP) \> 15mmHg. * 4\. Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the ISHLT guideline. This includes at least two of the following hemodynamic and/or echocardiographic measurements: * Right ventricular ejection fraction (RVEF)≤ 30%; * Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg\*L/m2; * Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm; * Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio\> 0.72; * Central venous pressure (CVP)\> 15 mmHg; * CVP to PCWP ratio\> 0.63; * Tricuspid insufficiency grade 2-4; * Pulmonary artery pressure index (PAPi)\< 2; * 5\. 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 \< 100k/µl 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\. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device. * 8\. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation. * 9\. 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, or FEV1 \< 50% predicted. * Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration; * 10\. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units. * 11\. Severe systemic light-chain amyloidosis. * 12\. Blood stream infection within seven days. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion. * 13\. Sepsis * 14\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter. * 15\. Any condition other than HF that could limit survival to less than 24 months. * 16\. Positive pregnancy test if of childbearing potential. * 17\. Lactating mothers. * 18\. Participation in any other clinical investigation that is likely to confound study results or affect 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

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Contacts and locations

Locations

  • Medizinische Hochschule Hannover

    Hanover, Germany

More trials for these conditions

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