Corheart 6 LVAS Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractory Heart Failure
• Intervention / Treatment: Device: Corheart 6 Left 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): 53
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Austria
  • Graz, Austria
    • Not yet recruiting
    • Universitätsklinikum Graz
    • Contact: Ao.Univ.-Prof.i.R. Dr.med.univ. Heinrich Mächler
  • Vienna, Austria
    • Recruiting
    • Universitätskliniken der MedUni Wien
    • Contact: Univ.-Prof. Priv.-Doz. Dr. Daniel Zimpfer
• Germany
  • Bad Oeynhausen, Germany
    • Recruiting
    • Herz-und Diabeteszentrum Nordrhein-Westfalen
    • Contact: Dr. med. Michiel Morshuis
  • Berlin, Germany
    • Recruiting
    • Deutsches Herzzentrum der Charité
    • Contact: Prof. Dr. med. Evgenij Potapov; Phone Number: +49 30 4593-2000; Email: evgenij.potapov@dhzc-charite.de
  • Bremen, Germany
    • Not yet recruiting
    • Klinikum Links der Weser
    • Contact: Prof. Dr. med. Jens Garbade
  • Hamburg, Germany
    • Recruiting
    • Universitätsklinikum Hamburg
    • Contact: Priv.-Doz. Dr. med. Alexander Bernhardt
  • Heidelberg, Germany
    • Recruiting
    • Universitätsklinikums Heidelberg
    • Contact: Prof. Dr. med. Anna Meyer
  • Leipzig, Germany
    • Recruiting
    • Herzzentrum Leipzig
    • Contact: Priv.-Doz. Dr. med. Alexey Dashkevich
  • Würzburg, Germany
    • Not yet recruiting
    • Universitatsklinikum Wurzburg
    • Contact: Univ.-Prof. Dr. med. Gloria Färber
• Italy
  • Milan, Italy
    • Not yet recruiting
    • IRCCS Ospedale San Raffaele
    • Contact: Prof. De Bonis Michele
  • Torino, Italy
    • Not yet recruiting
    • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
    • Contact: Prof. Antonio Loforte

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. 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 μmol/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 ≥ 265 μmol/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 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 LVAS; The Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced left ventricular heart failure.	Device: Corheart 6 Left Ventricular Assist System; Implantation of left ventricular assist device for mechanical circulatory support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of surivival	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.	Up to 6 months post-implantation

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
Composite of surivival	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.	Year 1, Year 2, Year 5

Collaborators and Investigators

• Sponsor: Shenzhen Core Medical Technology CO.,LTD.
• Investigators: Principal Investigator: Evgenij V Potapov, German Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2031

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): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Heart Failure; Mechanical Circulatory Support; Left Ventricular Assist System
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: COREMED_EU_LVAS

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