NCT07700810Not yet recruitingNot Applicable
A Prospective, Multicenter, Single-arm Clinical Investigation of the Corheart 6 Left Ventricular Assist System
Shenzhen Core Medical Technology CO.,LTD.0 sites100 target enrollmentStarted: January 31, 2027Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Composite Survival Rate without Disabling Stroke
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years and ≤ 75 years
- •The patient has signed an Informed Consent Form
- •Body Surface Area (BSA) ≥ 1.2 m2
- •New York Heart Association (NYHA) Class IV
- •Left Ventricular Ejection Fraction (LVEF) ≤ 25%
- •Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:
- •- - a. Unable to exercise for HF, or if able to perform cardiopulmonary testing, with peak VO2 <12 mL/kg/min and/or < 50% predicted value;
- •- - b. 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).
- •- - c. Impella or IABP assisted; Inotrope dependent/unable to wean from inotropes.
Exclusion Criteria
- •Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
- •Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
- •Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
- •Platelet count < 100,000 x 103/L (< 100,000/ml).
- •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.
- •Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
- •Presence of an active, uncontrolled infection.
- •Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
- •- - a. 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.
- •- - b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted.
- •- - c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention.
- •- - d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (> 70%) carotid artery stenosis
- •- - e. Serum creatinine ≥ 265umol/L (3.0mg/dl) or requiring dialysis.
- •- - f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
- •Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.
- •Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.
- •History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
- •Uncontrollable ventricular tachyarrythmias / ventricular fibrillation (VF).
- •STEMI <2 weeks before planned implantation.
- •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
- •Planned Bi-VAD support prior to enrollment.
- •Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.
- •History of any organ transplant.
- •Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL).
- •Any condition other than HF that could limit survival to less than 24 months
- •Positive pregnancy test if of childbearing potential.
- •Lactating mothers.
- •Participation in any other clinical investigation that is likely to confound study results or affect the study.
- •Patients who have been placed in an institution by court order or by order of the authorities.
Arms & Interventions
Corheart 6 LVAS
Experimental
The Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced left ventricular heart failure.
Intervention: Corheart 6 LVAS (Device)
Outcomes
Primary Outcomes
Composite Survival Rate without Disabling Stroke
Time Frame: 6 months after device implantation
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.
Secondary Outcomes
- Composite Survival Rate without Disabling Stroke(24 months after device implantation)
- Composite Survival Rate(5 years after device implantation)
- Bridge Heart Transplantation Rate(6 months, 12 months, 24 months, 5 years after surgery)
- Device Removal Rate(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(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)
- NYHA Functional Class assessed using the New York Heart Association (NYHA) Functional Classification (Class I-IV)(baseline, 6 months, 12 months, 24 months, 5 years after surgery)
- Anxiety assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7)(baseline, 6 months, 12 months, 24 months, 5 years after surgery)
- Depression assessed using the Patient Health Questionnaire-9 (PHQ-9)(baseline, 6 months, 12 months, 24 months, 5 years after surgery)
Investigators
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