Corheart 6 LVAS Long-term Follow-up Study

Official title

Long-term Follow-up Study of Corheart 6 Left Ventricular Assist System as Treatment of Patients With Advanced Heart Failure

Overview

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.

Interventions

• Device Corheart 6 Left Ventricular Assist System
  Implantation of left ventricular assist device for hemodynamic support

Primary outcome measures

• Device implantaion success rate at 24 months post-implantation [Time frame: Up to 24 months post-implantation]

Secondary outcome measures (10)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Nanjing First Hospital — Nanjing

Identifiers

NCT: NCT06267612 · KY20231109-11

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗