Evaluating the Corheart 6 LVAS for advanced heart failure treatment

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

This study is testing a new heart pump called the Corheart 6 to see if it can help adults with severe heart failure feel better and improve their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shenzhen Core Medical Technology CO.,LTD. (Industry-sponsored)
• Locations: 11 sites (Graz and 10 other locations)
• Trial ID: NCT05876000 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (LVAS) in patients with advanced left ventricular heart failure. It focuses on a European population and will evaluate outcomes at 6 months post-implantation, with a secondary goal of examining long-term safety and effectiveness. Eligible participants include adults aged 18 to 75 with severe heart failure symptoms despite optimal medical management. The study will provide insights into the potential benefits of this mechanical circulatory support device.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with NYHA Class IV heart failure and severely reduced left ventricular ejection fraction.

Not a fit: Patients whose heart failure can be managed with other therapies, such as CRT or CRT-D, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and survival rates for patients with advanced heart failure.

How similar studies have performed: Other studies involving mechanical circulatory support devices have shown promising results, indicating potential for success with this approach.

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 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.

Where this trial is running

Graz and 10 other locations

• 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)

Study contacts

• Principal investigator: Evgenij V Potapov — German Heart Institute
• Study coordinator: Xiaoli Shi

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