Corheart 6 LVAS Long-term Follow-up Study

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: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Corheart 6 Left Ventricular Assist System

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhibing Qiu; Phone Number: 025-52271064; Email: qiuzhibing2009@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital
      • Contact: Zhibing Qiu; Email: qiuzhibing2009@163.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 months post-implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	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	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	As they occur, from baseline to 24 months post-implantaion
Device-related re-operations	Frequency and incidence of all device-related re-operations	As they occur, from baseline to 24 months post-implantaion
Device-related re-hospitalizations	Frequency and incidence of all device-related re-hospitalizations	As they occur, from initial hospital discharge to 24 months post-implantation
Overall survival	Overall survival at 60 months post-implantation	Up to 60 months post-implantation

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Principal Investigator: Zhibing Qiu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2024
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID 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