Corheart 6 LVAS Study

Official title

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

Overview

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.

Interventions

• Device Corheart 6 Left Ventricular Assist System
  Implantation of left ventricular assist device for mechanical circulatory support

Primary outcome measures

• Composite of surivival [Time frame: Up to 6 months post-implantation]

Secondary outcome measures (7)

• Survival [Time frame: Year 1, Year 2, Year 3, Year 4, Year 5]
• Composite of surivival [Time frame: Year 1, Year 2, Year 5]
• Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
• Adverse Events [Time frame: As they occurred, from Baseline to Year 5]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 7 centers

• Herz-und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen
• Deutsches Herzzentrum der Charité — Berlin
• Klinikum Links der Weser — Bremen
• Universitätsklinikum Hamburg — Hamburg
• Universitätsklinikums Heidelberg — Heidelberg
• Herzzentrum Leipzig — Leipzig
• Universitätsklinikum Würzburg — Würzburg

Austria · 2 centers

• Universitätsklinikum Graz — Graz
• Universitätskliniken der MedUni Wien — Vienna

Italy · 2 centers

• IRCCS Ospedale San Raffaele — Milan
• Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino — Torino

Identifiers

NCT: NCT05876000 · COREMED_EU_LVAS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗