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

NCT05353816 | Active Not Recruiting DMC

• 1 other identifier: COREMED_LVAS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

End-stage Heart Failure

Keywords

End-stage Heart Failure; Ventricular Assist System; Mechanical Circulatory Support

Outcome Measures

Primary Outcomes (2)

• 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.

• The event-free survival at 24 months post-implantation.

  Survival at 24 months post-implantation free of disabling stroke (mRS \>3) or reoperation for device replacement. Subjects who undergo heart transplantation or device explantation due to myocardial recovery are considered to have met the primary endpoint.

  Up to 24 months post-implantation

Secondary Outcomes (7)

• Functional status as measured by the New York Heart Association (NYHA) Classification

  Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.

• Quality of Life as measured by the EuroQoL-5D-3L (EQ-5D-3L) questionnaire

  Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.

• Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-23).

  Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.

• Functional status as measured by the Six Minute Walk Test (6MWT)

  Baseline, at hospital discharge (within 5 days), and at 3, 6, 12, 24 and 60 months post-implantation.

• Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score.

  From baseline to 60 months post-implantation.

Study Arms (1)

Corheart 6 LVAS

EXPERIMENTAL

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

Interventions

Corheart 6 Left Ventricular Assist System DEVICE

Implantation of the Corheart 6 Left Ventricular Assist Device for mechanical circulatory support.

Corheart 6 LVAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Shenzhen Core Medical Technology CO.,LTD.: lead

Study Sites (11)

Fuwai Hospital, Chinese Academy of Medical Sciences(CAMS)

Beijing, Beijing Municipality, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The Second XIANGYA Hospital Of Central South University

Changsha, Hunan, China

Location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Hunan, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

Xijing Hospital of Air Force Medical University

Xi’an, Shanxi, China

Location

People's Hospital of Xinjiang Uygur Autonomous Region

Xinjiang, Xinjiang, China

Location

Related Publications (1)

• Wang X, Chen H, Du J, Zhou X, Zou L, Huang J, Chen L, Cheng Z, Dong N, Chen X, Liu J, Yang Y, Wang C, Yang Y, Shen Z, Wang H, Hu S. A novel magnetically levitated intrapericardial left ventricular assist system in advanced heart failure-2-year results from a prospective, multi-centre study. Eur J Cardiothorac Surg. 2026 Jan 9:ezag014. doi: 10.1093/ejcts/ezag014. Online ahead of print.

  PMID: 41512307 DERIVED

Study Officials

• Shengshou Hu

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: April 29, 2022
• Study Start: January 26, 2022
• Primary Completion: September 30, 2024
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2025-08

Locations

CN (11)