Corheart 6 LVAS Study

Not Applicable

Recruiting

• Conditions: Refractory Heart Failure
• Interventions: Device: Corheart 6 Left Ventricular Assist System

• Registration Number: NCT05876000
• Lead Sponsor: Shenzhen Core Medical Technology CO.,LTD.

Brief Summary

The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.

The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-25
• Study Start: 2024-05-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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 m^2
• 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:
• 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;
• d. 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 10^3/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 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:
• 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.
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Corheart 6 LVAS	Corheart 6 Left Ventricular Assist System	The Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced left ventricular heart failure.

Primary Outcome Measures

Name	Time	Method
Composite of surivival	Up to 6 months post-implantation	At 6 months post-implantation, composite of survival to transplant, recovery, LVAS support free of disabling stroke (Modified Rankin Score \> 3), or re-operation to replace the pump due to pump failure.

Secondary Outcome Measures

Name	Time	Method
Survival	Year 1, Year 2, Year 3, Year 4, Year 5	Overall survival of patients
Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)	Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5	The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
Functional status as measured by the Six Minute Walk Test (6MWT)	Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5	The more meters a patient can walk over baseline indicates improvement in functional status.
Composite of surivival	Year 1, Year 2, Year 5	Composite of survival to transplant, recovery, LVAS support free of disabling stroke (Modified Rankin Score \> 3), or re-operation to replace the pump due to pump failure.
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5	Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Functional status as measured by the New York Heart Association (NYHA) Classification	Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5	NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status.
Adverse Events	As they occurred, from Baseline to Year 5	Frequency and incidence of all anticipated Adverse Event.

Trial Locations

Locations (10)

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum Hamburg; 🇩🇪 Hamburg, Germany

Uniklinik Köln; 🇩🇪 Köln, Germany

Deutsches Herzzentrum der Charité; 🇩🇪 Berlin, Germany

Universitätsklinikum des Saarlandes UKS; 🇩🇪 Homburg, Germany

Uniklinik Freiburg; 🇩🇪 Freiburg, Germany

Herzchirurgie Uniklinik Bonn; 🇩🇪 Bonn, Germany

Herz-und Diabeteszentrum Nordrhein-Westfalen; 🇩🇪 Bad Oeynhausen, Germany

Universitätsklinikum Graz; 🇦🇹 Graz, Austria

Universitätskliniken der MedUni Wien; 🇦🇹 Vienna, Austria