Clinical trial NCT06267612: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.


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.

Primary outcomes:
measure: Device implantaion success rate at 24 months post-implantation
timeFrame: Up to 24 months post-implantation
Secondary outcomes:
measure: Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23)
timeFrame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
measure: Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire
timeFrame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
measure: Functional status as measured by the Six Minute Walk Test (6MWT)
timeFrame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
measure: Functional status as measured by the New York Heart Association (NYHA) Classification
timeFrame: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation
measure: Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: 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
measure: Stroke severity as assessed by the modified Rankin Scale (mRS) score
timeFrame: 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
measure: Adverse events
timeFrame: As they occur, from baseline to 24 months post-implantaion
measure: Device-related re-operations
timeFrame: As they occur, from baseline to 24 months post-implantaion
measure: Device-related re-hospitalizations
timeFrame: As they occur, from initial hospital discharge to 24 months post-implantation
measure: Overall survival
timeFrame: Up to 60 months post-implantation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Zhibing Qiu
role: PRINCIPAL_INVESTIGATOR
References: