Corheart 6: Long-term Cohort Study

NCT07094919 | Recruiting

• 1 other identifier: 2025-ZX036
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 8

Brief Summary

This study aims to evaluate the long-term effectiveness and safety of Corheart 6 left ventricular assist system as a treatment for patients with advanced left heart failure. The patients who have received the Corheart 6 treatment since October 2021, or who are planned to received it, will be enrolled until the target sample size meets statistical requirements. Data collected will include survival status, cardiac function status, quality of life, laboratory parameters and adverse events. The primary endpoint are the composite of survival at 6 months and, separately, at 24 months, defined as survival with device support, bridge to heart transplant and device explantation due to cardiac recovery, without disabling stroke (mRS \> 3) or device replacement. Data collection will adhere to the follow-up schedule specified in the protocol.

Conditions

Heart Failure

Keywords

advanced heart failure; Corheart 6

Outcome Measures

Primary Outcomes (2)

• Composite survival rate at 6 months.

  The composite survival is defined as one of the following criteria, without disabling stroke (modified Rankin Score \>3 ), device replacement due to device malfunction, or urgent heart transplant due to device malfunction: * heart transplant; * explantation for cardiac recovery; * survival with device support.

  6 months

• Composite survival rate at 24 months

  24 months

Secondary Outcomes (7)

• Composite survival rate at 5 years post device implantation

  5 years

• NYHA Functional Class

  Baseline, 6 months, 24 months, and 5 years post-implantation

• 6-minute walk test distance

  Baseline, 6 months, 24 months, and 5 years post-implantation

• EuroQol-5D

  Baseline, 6 months, 24 months, 5 years post-implantation

• Adverse Events

  Up to 5-year post-implantaiton

Study Arms (1)

Corheart 6 Left Ventricular Assist System

EXPERIMENTAL

Subjects with advanced left heart failure despite receiving optimal medical therapy, as per current heart failure management guidelines

Device: Corheart 6 left ventricular assist system

Interventions

Corheart 6 left ventricular assist system DEVICE

Corheart 6 left ventricular assist system provides circulatory support for patients with advanced left heart failure.

Corheart 6 Left Ventricular Assist System

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Subject who have undergone Corheart 6 implantation on or after October 1, 2021.
• Body Surface Area (BSA) \> 1.0 m2.
• Women of childbearing potential must use agree to use a effective method of contraception for the duration of the study.
• Diagnosis of NYHA Class IV heart failure, refractory to optimal guideline-directed medical therapy (GDMT) (e.g., ACE inhibitors, β-blockers, and diuretics).
• Left Ventricular Ejection Fraction (LVEF) \< 30%, with at least one of the following conditions:
• Dependence on an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or other short-term mechanical circulatory support with an inability to be weaned.
• Dependence on continuous intravenous inotropic support.
• Meets the diagnostic criteria for cardiogenic shock: blood pressure \< 90/60 mmHg, cardiac index \< 2.0, pulmonary capillary wedge pressure \> 18 mmHg
• Subject or their legally authorized representative agrees to participate in the study and signs the informed consent form.

You may not qualify if:

• Heart failure caused by unresolved thyroid disease, hypertrophic obstructive cardiomyopathy, pericardial disease, or related conditions.
• Presence of active, uncontrolled infection confirmed through clinical symptoms and laboratory tests.
• Based on the investigator's judgment, presence of technical difficulties that would lead to unacceptable surgical risk.
• Subject is intolerant to anticoagulation or antiplatelet therapy, or cannot receive other perioperative and postoperative treatments deemed necessary by the investigator based on the patient's health condition.
• Require biventricular assist device support.
• Pregnancy.
• Presence of moderate to severe aortic regurgitation or a history of mechanical aortic valve implantation but refuse or is unable to converted to a bioprosthesis or oversewn at the time of LVAD implant.
• History of any organ transplant.
• Presence of unresolved thrombocytopenia or severe coagulopathy, such as disseminated intravascular coagulation (DIC).
• Preoperative total bilirubin (TBIL) \> 3.0 mg/dL, serum creatinine (SCr) \> 3.0 mg/dL, or requirement for dialysis within 48 hours prior to surgery.
• History of severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or diagnosed primary pulmonary hypertension.
• Presence of pulmonary embolism within 3 weeks prior to enrollment.
• Pulmonary artery systolic pressure greater than 60 mmHg and meet at least one of the criteria which prove the pulmonary vessels is unresponsive to pharmacologic intervention: a. most recent pulmonary vascular resistance (PVR) ≥ 8 Woods; b. transpulmonary pressure \> 20mmHg.
• History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter.
• Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (8)

Fuwai Hospital Chinese Academy of Medical Sciences

Shenzhen, Guangdong, China

RECRUITING

the 7Th People'S Hospital of Zhengzhou

Zhengzhou, Henan, China

RECRUITING

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

Wuhan, Hubei, China

RECRUITING

Wuhan asia heart hospital

Wuhan, Hubei, China

RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, China

RECRUITING

the First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Fuwai Hospital

Beijing, China

RECRUITING

Zhongshan Hospital Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Xianqiang Wang

CONTACT

+86 13331006960; qiangxianwang@163.com

Study Design

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

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: July 31, 2025
• Study Start: December 12, 2021
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2030
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (8)