Corheart 6 LVAS Clinical Investigation

A Prospective, Multicenter, Single-arm Clinical Investigation of the Corheart 6 Left Ventricular Assist System

To evaluate the safety and effectiveness of the Corheart 6 left ventricular assist system in providing mechanical support for blood circulation in patients with advanced left ventricular heart failure.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Left Ventricular Heart Failure
• Intervention / Treatment: Device: Corheart 6 LVAS

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leon Lai; Phone Number: +86 755 23225941; Email: laishengfeng@coretechmed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75 years
2. The patient has signed an Informed Consent Form
3. Body Surface Area (BSA) ≥ 1.2 m2
4. New York Heart Association (NYHA) Class IV
5. Left Ventricular Ejection Fraction (LVEF) ≤ 25%

6. Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:

   1. Unable to exercise for HF, or if able to perform cardiopulmonary testing, with peak VO2 <12 mL/kg/min and/or < 50% predicted value;
   2. Progressive end-organ dysfunction (worsening renal and/or hepatic function, type II pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP > 20 mmHg and SBP < 90 mmHg or CI < 2.0 L/min/m2).
   3. Impella or IABP assisted; Inotrope dependent/unable to wean from inotropes.

Exclusion Criteria:

• 1. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.) 2. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.

  3. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.

  4. Platelet count < 100,000 x 103/L (< 100,000/ml). 5. 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.

  6. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.

  7. Presence of an active, uncontrolled infection. 8. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:

  1. Total bilirubin > 51.3 umol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score.
  2. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted.
  3. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention.
  4. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (> 70%) carotid artery stenosis
  5. Serum creatinine ≥ 265umol/L (3.0mg/dl) or requiring dialysis.

  6. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.

     9. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.

     10. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.

     11. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.

     12. Uncontrollable ventricular tachyarrythmias / ventricular fibrillation (VF). 13. STEMI <2 weeks before planned implantation. 14. Right ventricular failure as defined by one or more of the following:

  a. Severe depressed RV function in echocardiography b. TAPSE < 1.0 cm c. CVP/PCWP ratio > 0.63 15. Planned Bi-VAD support prior to enrollment. 16. Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.

  17. History of any organ transplant. 18. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL). 19. Any condition other than HF that could limit survival to less than 24 months 20. Positive pregnancy test if of childbearing potential. 21. Lactating mothers. 22. Participation in any other clinical investigation that is likely to confound study results or affect the study.

  23. Patients who have been placed in an institution by court order or by order of the authorities.

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; The Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced left ventricular heart failure.	Device: Corheart 6 LVAS; Implantation of left ventricular assist device for mechanical circulatory support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Survival Rate without Disabling Stroke	Composite survival is defined as meeting one of the following conditions: Surviving with the original device for 6 months after surgery without disabling stroke (mRS score > 3 at 3 months after stroke), and without reoperation (replacement or removal) due to device problems;; Bridging to heart transplantation within 6 months after implantation;; Removal of the original device due to recovery of cardiac function within 6 months after implantation.	6 months after device implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Survival Rate without Disabling Stroke		24 months after device implantation
Composite Survival Rate	5-year composite survival rate after implantation	5 years after device implantation
Bridge Heart Transplantation Rate		6 months, 12 months, 24 months, 5 years after surgery
Device Removal Rate	Device removal rate due to recovery of cardiac function	6 months, 12 months, 24 months, 5 years after surgery
NYHA Cardiac Function Class		baseline, 6 months, 12 months, 24 months, 5 years after surgery
KCCQ Questionnaire	Kansas Cardiomyopathy Questionnaire (KCCQ)	baseline, 6 months, 12 months, 24 months, 5 years after surgery
Anxiety and Depression Self-Rating Scale		baseline, 6 months, 12 months, 24 months, 5 years after surgery
Adverse Events		6 months, 12 months, 24 months, 5 years after surgery
Device Failure Rate		6 months, 12 months, 24 months, 5 years after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2027
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2034

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Heart Failure; Mechanical Circulatory Support; Left Ventricular Assist System; advanced left ventricular heart failure
• Other Study ID Numbers: COREMED_Corheart 6

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