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End-stage Heart FailureNCT05928273

Corheart 6 LVAS LTFU

A study testing Corheart 6 Left Ventricular Assist System in people with End-stage Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) when used for the treatment of advanced refractory heart failure. Read more about this study

Who is it for?
Ages 19 to 75 yearsHealthy volunteers can take part
Conditions the study is for
End-stage 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
50 participants
Where
1 siteChina
Study dates
20 Dec 2021to 17 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

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 19 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Patient or legal representative has signed Informed Consent Form (ICF)
  • BSA ≥ 1.0 m2
  • Females of child bearing age must agree to use adequate contraception
  • Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by previous standardized oral treatment with anti-heart failure drugs (ACEI, beta-blockers and diuretics)
  • LVEF ≤ 30%,and at least one of the following conditions occurs:
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  • For those whose condition cannot be reversed or can't be removed by using intraaortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO) orother short-term mechanical circulation assistance;
  • Rely on continuous intravenous administration of one or more cardioactive drugs or positive inotropic drugs;
  • Meeting diagnostic criteria of cardiogenic shock: blood pressure < 90/60mmHg; Cardiac discharge index < 2.0; Pulmonary capillary wedge pressure > 18mmHg

Who cannot join

  • Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy,pericardial disease, amyloidosis or restrictive cardiomyopathy.
  • Active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
  • In the investigator's judgment, there are technical difficulties that lead to an unacceptable hig surgical risk.
  • The patient was intolerant to anticoagulant or antiplatelet therapy or was unable to receive other perioperative and postoperative treatments that the investigator deemed necessary based on the patient's health condition.
  • Patients require biventricular assist device support.
  • Pregnancies.
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  • The patient had moderate to severe aortic insufficiency or a history of mechanical aortic valve implantation, but did not agree or could not be corrected by replacement or replacement of biological valve during LVAD implantation.
  • History of visceral organ transplantation.
  • Have uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
  • TBIL (total bilirubin) > 3.0 mg/dL and serum creatinine (SCr) > 3.0 mg/dL within 48 hours before surgery may require dialysis.
  • History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension。
  • Pulmonary embolism and pulmonary artery systolic blood pressure exceeding 60mmHg within 3 weeks prior to enrollment combined with at least one of the following 2 parameters demonstrated that pulmonary vascular resistance did not respond to drug therapy: pulmonary vascular resistance greater than 8 wood units; The transpulmonary differential pressure exceeds 20mmHg.
  • Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter.
  • Severe peripheral vascular disease with resting pain or extremity ulceration.
  • Patients with psychiatric disorders/disorders, irreversible cognitive impairment or psychosocial problems are at risk of failing to comply with research protocols and regulations governing the use of implantable LEFT ventricular assist systems or brain death from various causes.
  • Expect to live less than 1 year if you have a malignant tumor or other disease.
  • Patients participate in any other clinical trials that may influence the results of this study.
  • Other circumstances that are unforeseen and determined by the researcher to be unsuitable.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037

Other trials in China

About this study

Official title: Corheart 6 Left Ventricular Assist System Long Term Follow-up Clinical Evaluation Plan

This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) when used for the treatment of advanced refractory heart failure.

Being tested
Corheart 6 Left Ventricular Assist System

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 hemodynamic support

Study groups in NCT05928273
Study groupRoleWhat they receive
Corheart 6 LVASExperimentalCorheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced refractory 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.

  1. Survival [ Time Frame: 6 months ]

    Patients survived with the device for at least 6 months without disabling stroke (disabling stroke disabling stroke defined as a mRS Score > 3 at 60 days after stroke) and without reoperation (replacement or removal) due to device problems.

    Measured: 6 months

Secondary outcomes (4)

  1. Quality of Life (EQ-5D-5L)

    The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group. Patients describe their perceived health status using an analog scale with 0 as the worst health the patient can imagine and 100 as the best health (Visual Analog Score). The patients' scores at one, three and six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.

    Measured: Baseline, Month 1, Month 3, Month 6

  2. Functional Status - Six Minute Walk Test (6MWT)

    The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes.The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.

    Measured: [ Time Frame: Baseline, Month 1, Month 3, Month 6 ]

  3. New York Heart Association (NYHA) Classification

    NYHA classification relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort

    Measured: Baseline, Month 1, Month 3, Month 6

  4. 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 1, Month 3, Month 6

Timeline

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

  1. First posted3 Jul 2023
  2. Study start20 Dec 2021
  3. Primary completion10 Jul 2022
  4. Study completion17 Jan 2023

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05928273
Sponsor's protocol ID
COREMED_LVAD
Status last verified
Mar 2023
First submitted
17 Mar 2023
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
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 Left Ventricular Assist System in people with End-stage Heart Failure, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.

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 18 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: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival [ Time Frame: 6 months ] (time frame: 6 months). 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 NCT05928273.

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 3 Jul 2023.

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