Corheart 6 LVAS Long-term Follow-up Study

Nanjing Medical University

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Device: Corheart 6 Left Ventricular Assist System

Study type: Interventional

Funder types: Other

Identifiers

NCT06267612

KY20231109-11

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Corheart 6 LVAS

Experimental group

Description:

Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced heart failure.

Treatment:

Device: Corheart 6 Left Ventricular Assist System