Corheart 6 VAS Study

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractory Heart Failure
• Intervention / Treatment: Device: Corheart 6 Ventricular Assist System

Detailed Description

This study will evaluate the performance of the Corheart 6 VAS, side effects and undesirable conditions within acceptable risks and weigh them against the intended performance of the Corheart 6 VAS in accordance with general safety and performance requirements of MDR.

The study is a prospective, single arm, multi-center, clinical evaluation trial. The study will be conducted as a staged pivotal study that includes an interim analysis for safety and effectiveness. An interim analysis for safety and effectiveness will be performed after the first 10 Corheart 6 VAS patients have completed the 6 months of follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoli Shi; Phone Number: +86 13418601356; Email: shixiaoli@coretechmed.com

Study Locations

• Germany
  • Berlin, Germany
    • Deutsches Herzzentrum der Charité
    • Contact: Evgenij V Potapov; Phone Number: +49 30 4593 2065; Email: evgenij.potapov@dhzc-charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corheart 6 VAS; Corheart 6 Ventricular Assist System (Corheart 6 VAS) to be used on patients with advanced refractory heart failure.	Device: Corheart 6 Ventricular Assist System; Implantation of ventricular assist device for hemodynamic support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Overall survival of patients	Year 1, Year 2, Year 3, Year 4, Year 5
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
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
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
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
Adverse Events	Frequency and incidence of all anticipated Adverse Event.	As they occurred, from Baseline to Year 5

Collaborators and Investigators

• Sponsor: Shenzhen Core Medical Technology CO.,LTD.
• Investigators: Principal Investigator: Evgenij V Potapov, Deutsches Herzzentrum der Charité

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: advanced heart failure; ventricular assist system
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: COREMED_EU_VAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this moment the IPD is not yet available for access and will be updated when it is ready.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No