Corheart 6 LVAS Long-term Follow-up Study

February 12, 2024 updated by: Zhibing Qiu, Nanjing First Hospital, Nanjing Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:
  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Corheart 6 LVAS
Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced heart failure.
Device: Corheart 6 Left Ventricular Assist System
Implantation of left ventricular assist device for hemodynamic support

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months post-implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
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
The scores from the 5 dimensions are summed for the total score, with higher scores indicating more problems and a worse quality of life.
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
The more meters a patient can walk over baseline indicates improvement in functional status.
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
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.
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
Scores range from 0 to 42. Higher scores indicate more severe disability
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
Scores range from 0 to 6. Higher scores indicate more severe disability
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
Frequency and incidence of all anticipated adverse events
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
Frequency and incidence of all device-related re-operations
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
Frequency and incidence of all device-related re-hospitalizations
As they occur, from initial hospital discharge to 24 months post-implantation
Overall survival
Time Frame: Up to 60 months post-implantation
Overall survival at 60 months post-implantation
Up to 60 months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing First Hospital, Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhibing Qiu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20231109-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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