Heart FailureNCT06267612
Corheart 6 LVAS Long-term Follow-up Study
A study testing Corheart 6 Left Ventricular Assist System in people with Heart Failure, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2024to 30 Jun 2030
- 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
- 1. Age ≥ 18 years.
- 2. The patient or legal representative is willing to participate in the study and offers informed consent.
- 3. Body surface area (BSA) ≥ 1.0 m^2.
- 4. Females of childbearing age must agree to use adequate contraception.
- 5. Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by standardized treatment with oral anti-heart failure drugs.
- 6. Left Ventricular Ejection Fraction (LVEF) ≤ 35%, and at least one of the following conditions occurs:
Show all 9Show fewer
- a. Fail to be reversed by or be weaned from intra-aortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO), or other short-term mechanical circulatory support.
- b. Rely on continuous intravenous administration of one or more vasoactive or inotropic drugs.
- c. Meeting the diagnostic criteria of cardiogenic shock: blood pressure < 90/60mmHg, cardiac index < 2.0 L/min/m^2 (optional), and pulmonary capillary wedge pressure > 18mmHg (optional).
Who cannot join
- 1. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive hypertrophic cardiomyopathy, or pericardial disease.
- 2. Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
- 3. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
- 4. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy the investigator will require based on the patient's health status.
- 5. Patients require bi-ventricular assist device support.
- 6. Pregnancy.
Show all 24Show fewer
- 7. Presence of moderate to severe aortic insufficiency or a history of the mechanical aortic valve that will not be converted to a bioprosthesis or oversewn at the time of implantation.
- 8. History of any organ transplantation.
- 9. Presence of uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
- 10. TBIL (total bilirubin) > 3.0 mg/dL within 48 hours prior to implantation.
- 11. Serum creatinine (SCr) > 3.0 mg/dL within 48 hours prior to implantation or may require dialysis.
- 12. Presence of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension.
- 13. Presence of pulmonary embolism within 3 weeks prior to implantation.
- 14. Pulmonary artery systolic pressure exceeds 60mmHg, combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy:
- a. Pulmonary vascular resistance greater than 8 wood units.
- b. The transpulmonary differential pressure exceeds 20mmHg.
- 15. Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter.
- 16. Presence of severe peripheral vascular disease with resting pain or extremity ulceration.
- 17. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management, or brain death from various causes.
- 18. History of documented disabling stroke within 90 days prior to implantation, a history of cerebrovascular disease, or the presence of uncorrected severe bilateral carotid artery stenosis.
- 19. History of acute myocardial infarction within 60 days prior to implantation, judged by the investigator to have a risk of myocardial rupture or other surgical high-risk difficult-to-control bleeding, etc.
- 20. Expected lifetime of less than 1 year due to malignant tumor or other disease.
- 21. Participation in any other clinical study that may influence the results of this study.
- 22. Other circumstances that are unforeseen and determined by the researcher to be unsuitable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing First Hospital
Nanjing, Jiangsu
Zhibing Qiu, qiuzhibing2009@163.com
About this study
Official title: Long-term Follow-up Study of Corheart 6 Left Ventricular Assist System as Treatment of Patients With Advanced Heart Failure
The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.
The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.
- Conditions
- Heart Failure
- Being tested
- Corheart 6 Left Ventricular Assist System
- 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 hemodynamic support
| Study group | Role | What they receive |
|---|---|---|
| Corheart 6 LVAS | Experimental | Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced 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.
Device implantaion success rate at 24 months post-implantation
Device implantation success is defined as:
- A. Electively transplanted or explanted prior to 24 months or
- B. Alive at 24 months, and
- I. Have not experienced a stroke with a modified Rankin Score > 3, and
- II. Have not received a device replacement or exchange due to a device malfunction, and
- III. Have not received an urgent transplant due to a device malfunction.
Measured: Up to 24 months post-implantation
Secondary outcomes (10)
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)
Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Measured: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire
The scores from the 5 dimensions are summed for the total score, with higher scores indicating more problems and a worse quality of life.
Measured: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
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, at 6 months, 12 months, 18 months, and 24 months post-implantation
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, at 6 months, 12 months, 18 months, and 24 months post-implantation
Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score
Scores range from 0 to 42. Higher scores indicate more severe disability
Measured: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation
Stroke severity as assessed by the modified Rankin Scale (mRS) score
Scores range from 0 to 6. Higher scores indicate more severe disability
Measured: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation
Adverse events
Frequency and incidence of all anticipated adverse events
Measured: As they occur, from baseline to 24 months post-implantaion
Device-related re-operations
Frequency and incidence of all device-related re-operations
Measured: As they occur, from baseline to 24 months post-implantaion
Device-related re-hospitalizations
Frequency and incidence of all device-related re-hospitalizations
Measured: As they occur, from initial hospital discharge to 24 months post-implantation
Overall survival
Overall survival at 60 months post-implantation
Measured: Up to 60 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start10 Feb 2024 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhibing Qiu, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Zhibing Qiu, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267612
- Sponsor's protocol ID
- KY20231109-11
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study of Corheart 6 Left Ventricular Assist System as Treatment of Patients With Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT06267612
- Acronym / sponsor ID
- KY20231109-11
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 20 Feb 2024 (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 purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.
The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.
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 SystemCorheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age ≥ 18 years.
- 2. The patient or legal representative is willing to participate in the study and offers informed consent.
- 3. Body surface area (BSA) ≥ 1.0 m^2.
- 4. Females of childbearing age must agree to use adequate contraception.
- 5. Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by standardized treatment with oral anti-heart failure drugs.
Key exclusion criteria (24 listed)
- 1. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive hypertrophic cardiomyopathy, or pericardial disease.
- 2. Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
- 3. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
- 4. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy the investigator will require based on the patient's health status.
- 5. Patients require bi-ventricular assist device support.
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 hemodynamic support | Device | Corheart 6 LVAS |
Primary outcome
Device implantaion success rate at 24 months post-implantation
Time frame: Up to 24 months post-implantation
Device implantation success is defined as: * A. Electively transplanted or explanted prior to 24 months or * B. Alive at 24 months, and * I. Have not experienced a stroke with a modified Rankin Score > 3, and * II. Have not received a device replacement or exchange due to a device malfunction, and * III. Have not received an urgent transplant due to a device malfunction.
10 secondary outcomes
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
Functional status as measured by the Six Minute Walk Test (6MWT)
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
Functional status as measured by the New York Heart Association (NYHA) Classification
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation
Stroke severity as assessed by the modified Rankin Scale (mRS) score
Time frame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation
Adverse events
Time frame: As they occur, from baseline to 24 months post-implantaion
Device-related re-operations
Time frame: As they occur, from baseline to 24 months post-implantaion
Device-related re-hospitalizations
Time frame: As they occur, from initial hospital discharge to 24 months post-implantation
Overall survival
Time frame: Up to 60 months post-implantation
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 20 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
Heart Failure, Heart Failure With Preserved Ejection Fraction
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.
Zhibing Qiu principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: 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 Heart Failure, run by Nanjing First Hospital, Nanjing Medical University 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 24 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 20 Feb 2024. 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?
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 Zhibing Qiu (025-52271064, qiuzhibing2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device implantaion success rate at 24 months post-implantation (time frame: Up to 24 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 20 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.