Corheart 6 LVAS Study

NCT05876000 | Recruiting DMC

• 1 other identifier: COREMED_EU_LVAS
• Study Type: interventional
• Target: 53
• Locations: 3 countries
• Sites: 11

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.

Conditions

Refractory Heart Failure

Keywords

Advanced Heart Failure; Left Ventricular Assist System; Mechanical Circulatory Support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Survival

  Year 1, Year 2, Year 3, Year 4, Year 5

• Composite of surivival

  Year 1, Year 2, Year 5

• 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

• 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

• 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

Study Arms (1)

Corheart 6 LVAS

EXPERIMENTAL

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

Interventions

Corheart 6 Left Ventricular Assist System DEVICE

Implantation of left ventricular assist device for mechanical circulatory support

Corheart 6 LVAS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years and ≤ 75 years
• \. The patient has signed an Informed Consent Form
• \. Body Surface Area (BSA) ≥ 1.2 m\^2
• \. New York Heart Association (NYHA) Class IV
• \. Left Ventricular Ejection Fraction (LVEF) ≤ 25%
• \. 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,
• 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.

You may not qualify if:

• \. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
• \. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
• \. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
• \. Platelet count \< 100,000 x 10\^3/L (\< 100,000/ml).
• \. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management.
• \. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
• \. Presence of an active, uncontrolled infection.
• \. 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.
• \. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.

Sponsors & Collaborators

• Shenzhen Core Medical Technology CO.,LTD.: lead

Study Sites (11)

Universitätsklinikum Graz

Graz, Austria

NOT YET RECRUITING

Universitätskliniken der MedUni Wien

Vienna, Austria

RECRUITING

Herz-und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, Germany

RECRUITING

Deutsches Herzzentrum der Charité

Berlin, Germany

RECRUITING

Klinikum Links der Weser

Bremen, Germany

NOT YET RECRUITING

Universitätsklinikum Hamburg

Hamburg, Germany

RECRUITING

Universitätsklinikums Heidelberg

Heidelberg, Germany

RECRUITING

Herzzentrum Leipzig

Leipzig, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Germany

NOT YET RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Torino, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Evgenij V Potapov

  German Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoli Shi

CONTACT

+86 13418601356; shixiaoli@coretechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 25, 2023
• Study Start: May 14, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2031
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

DE (7); IT (2); AU (2)