New dual heart pump offers hope for patients with End-Stage heart failure
NCT ID NCT07233876
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Medizinische Hochschule Hannover
Hanover, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new care pathway speed up advanced heart failure decisions?
- Can a Dual-Chamber heart pump save the failing heart?
- Can a mechanical heart pump offer a lifeline for advanced heart failure?
- Heart-Kidney link under microscope in advanced heart failure study
- New heart pump offers hope for advanced heart failure patients
- Could LVAD patients ditch aspirin? new trial aims to find out