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Advanced Left Ventricular Heart FailureNCT07700810

Corheart 6 LVAS Clinical Investigation

A study testing Corheart 6 LVAS in people with Advanced Left Ventricular Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To evaluate the safety and effectiveness of the Corheart 6 left ventricular assist system in providing mechanical support for blood circulation in patients with advanced left ventricular heart failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Left Ventricular Heart Failure
What is being tested?
Corheart 6 LVAS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
31 Jan 2027to 31 Jan 2034
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years and ≤ 75 years
  • The patient has signed an Informed Consent Form
  • Body Surface Area (BSA) ≥ 1.2 m2
  • New York Heart Association (NYHA) Class IV
  • Left Ventricular Ejection Fraction (LVEF) ≤ 25%
  • Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:
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  • - - 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; Inotrope dependent/unable to wean from inotropes.

Who cannot join

  • Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
  • Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
  • Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
  • Platelet count < 100,000 x 103/L (< 100,000/ml).
  • Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and left ventricular assist system management.
  • Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
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  • Presence of an active, uncontrolled infection.
  • Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
  • - - a. Total bilirubin > 51.3 umol/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 ≥ 265umol/L (3.0mg/dl) or requiring dialysis.
  • - - f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
  • Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.
  • Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.
  • History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
  • Uncontrollable ventricular tachyarrythmias / ventricular fibrillation (VF).
  • STEMI <2 weeks before planned implantation.
  • 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
  • Planned Bi-VAD support prior to enrollment.
  • Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.
  • History of any organ transplant.
  • Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL).
  • Any condition other than HF that could limit survival to less than 24 months
  • Positive pregnancy test if of childbearing potential.
  • Lactating mothers.
  • Participation in any other clinical investigation that is likely to confound study results or affect the study.
  • Patients who have been placed in an institution by court order or by order of the authorities.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Leon Lai contact

+86 755 23225941

laishengfeng@coretechmed.com

About this study

Official title: A Prospective, Multicenter, Single-arm Clinical Investigation of the Corheart 6 Left Ventricular Assist System

To evaluate the safety and effectiveness of the Corheart 6 left ventricular assist system in providing mechanical support for blood circulation in patients with advanced left ventricular heart failure.

Being tested
Corheart 6 LVAS
Keywords
advanced left ventricular heart failure, Advanced Heart Failure, Left Ventricular Assist System, Mechanical Circulatory Support

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Corheart 6 LVASDevice

    Implantation of left ventricular assist device for mechanical circulatory support

Study groups in NCT07700810
Study groupRoleWhat they receive
Corheart 6 LVASExperimentalThe Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced left ventricular heart failure.
Receives: Device: Corheart 6 LVAS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Survival Rate without Disabling Stroke

    Composite survival is defined as meeting one of the following conditions:

    • Surviving with the original device for 6 months after surgery without disabling stroke (mRS score > 3 at 3 months after stroke), and without reoperation (replacement or removal) due to device problems;
    • Bridging to heart transplantation within 6 months after implantation;
    • Removal of the original device due to recovery of cardiac function within 6 months after implantation.

    Measured: 6 months after device implantation

Secondary outcomes (10)

  1. Composite Survival Rate without Disabling Stroke

    Measured: 24 months after device implantation

  2. Composite Survival Rate

    5-year composite survival rate after implantation

    Measured: 5 years after device implantation

  3. Bridge Heart Transplantation Rate

    Measured: 6 months, 12 months, 24 months, 5 years after surgery

  4. Device Removal Rate

    Device removal rate due to recovery of cardiac function

    Measured: 6 months, 12 months, 24 months, 5 years after surgery

  5. NYHA Functional Class assessed using the New York Heart Association (NYHA) Functional Classification (Class I-IV)

    The outcome measure will be assessed using the New York Heart Association (NYHA) Functional Classification, a clinician-assessed four-class scale (Class I-IV) that categorizes the severity of heart failure symptoms based on the patient's physical activity limitations and symptoms.

    Measured: baseline, 6 months, 12 months, 24 months, 5 years after surgery

  6. KCCQ Questionnaire

    Kansas Cardiomyopathy Questionnaire (KCCQ)

    Measured: baseline, 6 months, 12 months, 24 months, 5 years after surgery

  7. Anxiety assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7)

    Anxiety will be assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7), a validated 7-item patient-reported questionnaire with scores ranging from 0 to 21, where higher scores indicate more severe anxiety symptoms.

    Measured: baseline, 6 months, 12 months, 24 months, 5 years after surgery

  8. Depression assessed using the Patient Health Questionnaire-9 (PHQ-9)

    Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item patient-reported questionnaire with scores ranging from 0 to 27, where higher scores indicate more severe depressive symptoms.

    Measured: baseline, 6 months, 12 months, 24 months, 5 years after surgery

  9. Adverse Events

    Measured: 6 months, 12 months, 24 months, 5 years after surgery

  10. Device Failure Rate

    Measured: 6 months, 12 months, 24 months, 5 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start31 Jan 2027 (estimated)
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2034 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07700810
Sponsor's protocol ID
COREMED_Corheart 6
Status last verified
Jul 2026
First submitted
8 Jul 2026
Last updated
17 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Corheart 6 LVAS in people with Advanced Left Ventricular Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD..

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 9 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: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Leon Lai (+86 755 23225941, laishengfeng@coretechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Survival Rate without Disabling Stroke (time frame: 6 months after device implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07700810.

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 17 Jul 2026.

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