Corheart 6 LVAS Clinical Investigation

Official title

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

Overview

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.

Interventions

• Device Corheart 6 LVAS
  Implantation of left ventricular assist device for mechanical circulatory support

Primary outcome measures

• Composite Survival Rate without Disabling Stroke [Time frame: 6 months after device implantation]

Secondary outcome measures (10)

• Composite Survival Rate without Disabling Stroke [Time frame: 24 months after device implantation]
• Composite Survival Rate [Time frame: 5 years after device implantation]
• Bridge Heart Transplantation Rate [Time frame: 6 months, 12 months, 24 months, 5 years after surgery]
• Device Removal Rate [Time frame: 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) [Time frame: baseline, 6 months, 12 months, 24 months, 5 years after surgery]
• KCCQ Questionnaire [Time frame: baseline, 6 months, 12 months, 24 months, 5 years after surgery]
• Anxiety assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7) [Time frame: baseline, 6 months, 12 months, 24 months, 5 years after surgery]
• Depression assessed using the Patient Health Questionnaire-9 (PHQ-9) [Time frame: baseline, 6 months, 12 months, 24 months, 5 years after surgery]
• Adverse Events [Time frame: 6 months, 12 months, 24 months, 5 years after surgery]
• Device Failure Rate [Time frame: 6 months, 12 months, 24 months, 5 years after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07700810 · COREMED_Corheart 6

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗