Corheart 6 LVAS Long-term Follow-up Study

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06267612
• Other study ID #: KY20231109-11
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: June 30, 2030

Study information

• Verified date: February 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Zhibing Qiu
• Phone: 025-52271064
• Email: qiuzhibing2009[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	Frequency and incidence of all anticipated adverse events	As they occur, from baseline to 24 months post-implantaion
Secondary	Device-related re-operations	Frequency and incidence of all device-related re-operations	As they occur, from baseline to 24 months post-implantaion
Secondary	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
Secondary	Overall survival	Overall survival at 60 months post-implantation	Up to 60 months post-implantation