Refractory Heart FailureNCT05876000
Corheart 6 LVAS Study
A study testing Corheart 6 Left Ventricular Assist System in people with Refractory Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 11 sites in 3 countries.
Trial summary
The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Refractory Heart Failure
- What is being tested?
- Corheart 6 Left Ventricular Assist System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 14 May 2024to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥ 18 years and ≤ 75 years
- 2. The patient has signed an Informed Consent Form
- 3. Body Surface Area (BSA) ≥ 1.2 m^2
- 4. New York Heart Association (NYHA) Class IV
- 5. Left Ventricular Ejection Fraction (LVEF) ≤ 25%
- 6. Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:
Show all 12Show fewer
- a. Unable to exercise for HF,
- or
- if able to perform cardiopulmonary testing, with peak VO2 <12 mL/kg/min and/or < 50% predicted value;
- b. Progressive end-organ dysfunction (worsening renal and/or hepatic function, type II pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP > 20 mmHg and SBP < 90 mmHg or CI < 2.0 L/min/m2).
- c. Impella or IABP assisted;
- d. Inotrope dependent/unable to wean from inotropes.
Who cannot join
- 1. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
- 2. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
- 3. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
- 4. Platelet count < 100,000 x 10^3/L (< 100,000/ml).
- 5. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management.
- 6. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
Show all 32Show fewer
- 7. Presence of an active, uncontrolled infection.
- 8. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
- a. Total bilirubin > 51.3 μmol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score.
- b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted.
- c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention.
- d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (> 70%) carotid artery stenosis
- e. Serum creatinine ≥ 265 μmol/L (3.0mg/dl) or requiring dialysis.
- f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
- 9. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.
- 10. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.
- 11. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
- 12. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF).
- 13. STEMI <2 weeks before planned implantation.
- 14. Right ventricular failure as defined by one or more of the following:
- a. severe depressed RV function in echocardiography
- b. TAPSE < 1.0 cm
- c. CVP/PCWP ratio > 0.63
- 15. Planned Bi-VAD support prior to enrollment.
- 16. Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.
- 17. History of any organ transplant.
- 18. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL).
- 19. Any condition other than HF that could limit survival to less than 24 months.
- 20. Positive pregnancy test if of childbearing potential.
- 21. Lactating mothers.
- 22. Participation in any other clinical investigation that is likely to confound study results or affect the study.
- 23. Patients who have been placed in an institution by court order or by order of the authorities.
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
Germany7 sites, 7 recruiting
- Recruiting
Herz-und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen
Dr. med. Michiel Morshuis
- Recruiting
Deutsches Herzzentrum der Charité
Berlin
Prof. Dr. med. Evgenij Potapov, +49 30 4593-2000, evgenij.potapov@dhzc-charite.de
- Not yet recruiting
Klinikum Links der Weser
Bremen
Prof. Dr. med. Jens Garbade
- Recruiting
Universitätsklinikum Hamburg
Hamburg
Priv.-Doz. Dr. med. Alexander Bernhardt
- Recruiting
Universitätsklinikums Heidelberg
Heidelberg
Prof. Dr. med. Anna Meyer
- Recruiting
Herzzentrum Leipzig
Leipzig
Priv.-Doz. Dr. med. Alexey Dashkevich
- Not yet recruiting
Universitätsklinikum Würzburg
Würzburg
Univ.-Prof. Dr. med. Gloria Färber
Austria2 sites, 2 recruiting
- Not yet recruiting
Universitätsklinikum Graz
Graz
Ao.Univ.-Prof.i.R. Dr.med.univ. Heinrich Mächler
- Recruiting
Universitätskliniken der MedUni Wien
Vienna
Univ.-Prof. Priv.-Doz. Dr. Daniel Zimpfer
Italy2 sites, 2 recruiting
- Not yet recruiting
IRCCS Ospedale San Raffaele
Milan
Prof. De Bonis Michele
- Not yet recruiting
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino
Prof. Antonio Loforte
About this study
Official title: Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Left Ventricular Assist System
The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.
The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.
- Conditions
- Refractory Heart Failure
- Being tested
- Corheart 6 Left Ventricular Assist System
- Keywords
- Advanced Heart Failure, Left Ventricular Assist System, Mechanical Circulatory Support
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corheart 6 Left Ventricular Assist SystemDevice
Implantation of left ventricular assist device for mechanical circulatory support
| Study group | Role | What they receive |
|---|---|---|
| Corheart 6 LVAS | Experimental | The Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced left ventricular heart failure. Receives: Device: Corheart 6 Left Ventricular Assist System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of surivival
At 6 months post-implantation, composite of survival to transplant, recovery, LVAS support free of disabling stroke (Modified Rankin Score > 3), or re-operation to replace the pump due to pump failure.
Measured: Up to 6 months post-implantation
Secondary outcomes (7)
Survival
Overall survival of patients
Measured: Year 1, Year 2, Year 3, Year 4, Year 5
Composite of surivival
Composite of survival to transplant, recovery, LVAS support free of disabling stroke (Modified Rankin Score > 3), or re-operation to replace the pump due to pump failure.
Measured: Year 1, Year 2, Year 5
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Measured: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)
The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
Measured: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Functional status as measured by the Six Minute Walk Test (6MWT)
The more meters a patient can walk over baseline indicates improvement in functional status.
Measured: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Functional status as measured by the New York Heart Association (NYHA) Classification
NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status.
Measured: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Adverse Events
Frequency and incidence of all anticipated Adverse Event.
Measured: As they occurred, from Baseline to Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start14 May 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Core Medical Technology CO.,LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evgenij V Potapov, Principal investigator, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876000
- Sponsor's protocol ID
- COREMED_EU_LVAS
- Status last verified
- Jan 2026
- First submitted
- 24 Apr 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this moment the IPD is not yet available for access and will be updated when it is ready.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Left Ventricular Assist System
- ClinicalTrials.gov ID
- NCT05876000
- Acronym / sponsor ID
- COREMED_EU_LVAS
- Conditions
- Refractory Heart Failure
- Keywords
- Advanced Heart Failure, Left Ventricular Assist System, Mechanical Circulatory Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Shenzhen Core Medical Technology CO.,LTD.Industry (pharma, biotech, devices)
- Study start
- 14 May 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.
The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corheart 6 LVAS | Experimental | Device: Corheart 6 Left Ventricular Assist SystemThe Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced left ventricular heart failure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Age ≥ 18 years and ≤ 75 years
- 2. The patient has signed an Informed Consent Form
- 3. Body Surface Area (BSA) ≥ 1.2 m^2
- 4. New York Heart Association (NYHA) Class IV
- 5. Left Ventricular Ejection Fraction (LVEF) ≤ 25%
Key exclusion criteria (32 listed)
- 1. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
- 2. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
- 3. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
- 4. Platelet count < 100,000 x 10^3/L (< 100,000/ml).
- 5. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corheart 6 Left Ventricular Assist SystemImplantation of left ventricular assist device for mechanical circulatory support | Device | Corheart 6 LVAS |
Primary outcome
Composite of surivival
Time frame: Up to 6 months post-implantation
At 6 months post-implantation, composite of survival to transplant, recovery, LVAS support free of disabling stroke (Modified Rankin Score > 3), or re-operation to replace the pump due to pump failure.
7 secondary outcomes
Survival
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5
Composite of surivival
Time frame: Year 1, Year 2, Year 5
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)
Time frame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Functional status as measured by the Six Minute Walk Test (6MWT)
Time frame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Functional status as measured by the New York Heart Association (NYHA) Classification
Time frame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Adverse Events
Time frame: As they occurred, from Baseline to Year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided. At this moment the IPD is not yet available for access and will be updated when it is ready.
Related trials for Refractory Heart Failure
Active, not recruitingPhase 4
Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure
Heart Failure
Recruiting
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
Cardiovascular Diseases, Heart Diseases
Recruiting
Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart Failure
Right Heart Failure
Recruiting
European Study of the BrioVAD Heart Pump for Advanced Heart Failure
Refractory Heart Failure, Cardiovascular Diseases (CVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evgenij V Potapov principal investigator
German Heart Institute
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corheart 6 Left Ventricular Assist System in people with Refractory Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Shi (+86 13418601356, shixiaoli@coretechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of surivival (time frame: Up to 6 months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.