Clinical trial NCT05876000: Corheart 6 LVAS Study
Official title: Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Left Ventricular Assist System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Heart Failure
Keywords: Advanced Heart Failure
Left Ventricular Assist System
Mechanical Circulatory Support
Lead sponsor: Shenzhen Core Medical Technology CO.,LTD.
Sponsor class: INDUSTRY
First posted: 2023-05-25
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Composite of surivival
timeFrame: Up to 6 months post-implantation
Secondary outcomes:
measure: Survival
timeFrame: Year 1, Year 2, Year 3, Year 4, Year 5
measure: Composite of surivival
timeFrame: Year 1, Year 2, Year 5
measure: Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
measure: Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)
timeFrame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
measure: Functional status as measured by the Six Minute Walk Test (6MWT)
timeFrame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
measure: Functional status as measured by the New York Heart Association (NYHA) Classification
timeFrame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
measure: Adverse Events
timeFrame: As they occurred, from Baseline to Year 5
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinikum Graz
city: Vienna
country: Austria
facility: Universitätskliniken der MedUni Wien
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Bonn
country: Germany
facility: Herzchirurgie Uniklinik Bonn
city: Freiburg
country: Germany
facility: Uniklinik Freiburg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes UKS
city: Köln
country: Germany
facility: Uniklinik Köln
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
Study officials:
affiliation: German Heart Institute
name: Evgenij V Potapov
role: PRINCIPAL_INVESTIGATOR
References: