Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial

This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure.

Study Overview

• Status: Completed
• Conditions: End-stage Heart Failure
• Intervention / Treatment: Device: Corheart 6 Left Ventricular Assist System

Detailed Description

The Corheart 6 Left Ventricular Assist System (also called "the Corheart 6 LVAS", or "the Corheart 6") is developed and manufactured by Shenzhen Core Medical Technology Co., Ltd. It is indicated for providing short-term and long-term mechanical circulatory support for patients with end-stage heart failure. This prospective, multi-center, and single-arm trial evaluates the safety and effectiveness of the device in treating patients with end-stage heart failure. 50 patients from 12 investigational sites will be enrolled for Corheart 6 VAS implantation and followed for 3 months post-implantation. The primary study endpoint is the success rate of device implantation at 3 months post-implantation. All adverse events will be adjudicated by an independent Clinical Events Committee (CEC).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lily Shi, VP; Phone Number: +8613418601356; Email: shixiaoli@coretechmed.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Fuwai Hospital, Chinese Academy of Medical Sciences(CAMS)
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Medical University Union Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital Of Central South University
    • Zhengzhou, Hunan, China
      • Fuwai Central China Cardiovascular Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital
    • Suzhou, Jiangsu, China
      • The First Affiliated Hospital of Soochow University
  • Shanghai
    • Shanghai, Shanghai, China
      • Zhongshan Hospital, Fudan University
  • Shanxi
    • Xi'an, Shanxi, China
      • Xijing Hospital of Air Force Medical University
  • Xinjiang
    • Xinjiang, Xinjiang, China
      • People's Hospital of Xinjiang Uygur Autonomous Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) Age ≥ 18 years.
• (2) The patient or legal representative has signed the Informed Consent Form (ICF).
• (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 previous standardized oral treatment with anti-heart failure drugs (ACEI, beta-blockers, and diuretics).
• (6) Left Ventricular Ejection Fraction (LVEF) ≤ 30%, 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, and pulmonary capillary wedge pressure > 18mmHg.

Exclusion Criteria:

• (1) Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy pericardial disease, amyloidosis, or restrictive cardiomyopathy.
• (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, serum creatinine (SCr) > 3.0 mg/dL within 48 hours prior to LVAD implantation surgery or may require dialysis.
• (11) History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension.
• (12) Pulmonary embolism and pulmonary artery systolic blood pressure exceeding 60mmHg within 3 weeks prior to enrollment combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy: Pulmonary vascular resistance greater than 8 wood units; The transpulmonary differential pressure exceeds 20mmHg.
• (13) Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter.
• (14) Presence of severe peripheral vascular disease with resting pain or extremity ulceration.
• (15) Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and Left Ventricular Assist System management, or brain death from various causes.
• (16) Expect to live less than 1 year due to malignant tumor or other diseases.
• (17) Participation in any other clinical trials that may influence the results of this study.
• (18) 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 end-stage heart failure.	Device: Corheart 6 Left Ventricular Assist System; Implantation of the Corheart 6 Left Ventricular Assist Device for mechanical circulatory support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of device implantation at 3 months.	The success rate of device implantation at 3 months post-implantation. Device implantation success will be met when a patient is still alive on device support, free of disabling stroke (modified Rankin Scale (mRS) > 3), and does not have the device replaced or removed due to device deficiency at 3 months post-implantation. The modified Rankin Scale is a tool used to assess functional disability or dependence in daily activities following a stroke or other neurological condition. It ranges from 0 (No observed neurological symptoms) to 6 (dead). Higher scores indicate more severe functional impairment.	Up to 3 months post-implantation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status as measured by the New York Heart Association (NYHA) Classification	The NYHA (New York Heart Association) Functional Classification is a tool used to assess the severity of heart failure symptoms. It categorizes patients into one of four classes based on their level of activity limitation and symptoms. Class I represents no limitation of physical activity, while Class IV indicates severe limitations even at rest.	Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
Quality of Life as measured by the EuroQoL-5D-3L (EQ-5D-3L) questionnaire	The EQ-5D-3L assesses health-related quality of life across five dimensions with three severity levels each. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 15 with higher scores indicating more problems and a worse quality of life.	Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-23).	The Kansas City Cardiomyopathy Questionnaire (KCCQ-3) evaluates heart failure patients' health status, including symptoms, physical limitations, social limitations, self-efficacy, and quality of life. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.	Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
Functional status as measured by the Six Minute Walk Test (6MWT)	The 6-Minute Walk Test (6MWT) assesses functional capacity and endurance by measuring the distance walked in six minutes. Results vary based on age, gender, and disease severity. Generally, greater distances indicate better functional capacity and endurance.	Baseline, at hospital discharge (assessed up to 5 days), and at 3 months post-implantation.
Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score.	The National Institutes of Health Stroke Scale measures stroke-related neurological deficits across various domains. Scores range from 0 to 42, with higher scores indicating more severe neurological impairment. Lower scores correlate with better neurological function.	From baseline to 3 months post-implantation.
Stroke severity as assessed by the modified Rankin Scale (mRS) score	The modified Rankin Scale is a tool used to assess functional disability or dependence in daily activities following a stroke or other neurological condition. It ranges from 0 (No observed neurological symptoms) to 6 (dead). Higher scores indicate more severe functional impairment.	From baseline to 3 months post-implantation.
Adverse Events	Frequency and incidence of all anticipated adverse events.	From baseline to 3 months post-implantation.

Collaborators and Investigators

• Sponsor: Shenzhen Core Medical Technology CO.,LTD.
• Investigators: Principal Investigator: Shengshou Hu, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Actual): October 8, 2022
• Study Completion (Actual): October 8, 2022

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Mechanical Circulatory Support; End-stage Heart Failure; Ventricular Assist System
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: COREMED_LVAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this moment the IPD is not yet available for access and will be updated when it is ready.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No