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NCT05876000 | Not yet recruiting | Refractory Heart Failure

Corheart 6 VAS Study
Sponsor:

Shenzhen Core Medical Technology CO.,LTD.

Brief Summary:

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.

Condition or disease

Refractory Heart Failure

Intervention/treatment

Corheart 6 Ventricular Assist System

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 50 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Ventricular Assist System
Actual Study Start Date : September 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : December 2029
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
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
Corheart 6 VAS Study

Location Details

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Corheart 6 VAS Study

How to Participate

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Locations

Not yet recruiting

Germany,

Charite German Heart Center

Berlin, Germany,