Corheart 6 VAS Study

Refractory Heart Failure Clinical Trial

Official title:

Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Ventricular Assist System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05876000
• Other study ID #: COREMED_EU_VAS
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: December 2029

Study information

• Verified date: May 2023
• Source: Shenzhen Core Medical Technology CO.,LTD.
• Contact: Xiaoli Shi
• Phone: +86 13418601356
• Email: shixiaoli[@]coretechmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety and effectiveness of the Corheart 6 Ventricular Assist System (Corheart 6 VAS) when used for the treatment of advanced refractory heart failure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2029
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1. Age = 18 years and = 75 years

• 2. BSA = 1.0 m^2

• 3. NYHA III or IV OR ACC/AHA Stage D

• 4. LVEF = 30%

• 5. Patients must also meet one or more of the following:

• CI = 2.2 L/min/m², while on Optimal Medical and Device Management, based on current heart failure practice guidelines;

• OR

• Impella or IABP assisted patient (based on doctors' judgement);

• OR

• Inotrope dependent/unable to wean from inotropes;

• OR

• Listed for heart transplantation.

Exclusion Criteria:

• 1. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.

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

• 3. Platelet count < 100,000 x 10^3/L (< 100,000/ml).

• 4. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management.

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

• 6. Presence of an active, uncontrolled infection.

• 7. 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 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) 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.

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

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

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

• 11. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF).

• 12. STEMI <2 weeks before planned implantation.

• 13. 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. PCWP/CVP <0.63

• 14. Planned Bi-VAD support prior to enrollment.

• 15. History of any organ transplant.

• 16. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL).

• 17. Any condition other than HF that could limit survival to less than 24 months.

• 18. Positive pregnancy test if of childbearing potential.

• 19. Lactating mothers.

• 20. Participation in any other clinical investigation that is likely to confound study results or affect the study.

Related Conditions & MeSH terms

• Heart Failure
• Refractory Heart Failure

Intervention

Device:
• Corheart 6 Ventricular Assist System
Implantation of ventricular assist device for hemodynamic support

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum der Charite	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Core Medical Technology CO.,LTD.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	At 6 months post-implantation, composite of survival to transplant, recovery or VAS support free of disabling stroke (Modified Rankin Score > 3) or re-operation to replace the pump due to pump failure.	6 months
Secondary	Survival	Overall survival of patients	Year 1, Year 2, Year 3, Year 4, Year 5
Secondary	Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.	Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Secondary	Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L)	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.	Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Secondary	Functional status as measured by the Six Minute Walk Test (6MWT)	The more meters a patient can walk over baseline indicates improvement in functional status.	Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Secondary	Functional status as measured by the New York Heart Association (NYHA) Classification	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.	Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Secondary	Adverse Events	Frequency and incidence of all anticipated Adverse Event.	As they occurred, from Baseline to Year 5