Clinical trial NCT05928273: Corheart 6 LVAS LTFU
Official title: Corheart 6 Left Ventricular Assist System Long Term Follow-up Clinical Evaluation Plan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Heart Failure
Lead sponsor: Shenzhen Core Medical Technology CO.,LTD.
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) when used for the treatment of advanced refractory heart failure.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Patient or legal representative has signed Informed Consent Form (ICF)
3. BSA ≥ 1.0 m2
4. Females of child bearing age must agree to use adequate contraception
5. Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by previous standardized oral treatment with anti-heart failure drugs (ACEI, beta-blockers and diuretics)
6. LVEF ≤ 30%,and at least one of the following conditions occurs:

   1. For those whose condition cannot be reversed or can't be removed by using intraaortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO) orother short-term mechanical circulation assistance;
   2. Rely on continuous intravenous administration of one or more cardioactive drugs or positive inotropic drugs;
   3. Meeting diagnostic criteria of cardiogenic shock: blood pressure \< 90/60mmHg; Cardiac discharge index \< 2.0; Pulmonary capillary wedge pressure \> 18mmHg

Exclusion Criteria:

1. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy,pericardial disease, amyloidosis or restrictive cardiomyopathy.
2. Active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
3. In the investigator's judgment, there are technical difficulties that lead to an unacceptable hig surgical risk.
4. The patient was intolerant to anticoagulant or antiplatelet therapy or was unable to receive other perioperative and postoperative treatments that the investigator deemed necessary based on the patient's health condition.
5. Patients require biventricular assist device support.
6. Pregnancies.
7. The patient had moderate to severe aortic insufficiency or a history of mechanical aortic valve implantation, but did not agree or could not be corrected by replacement or replacement of biological valve during LVAD implantation.
8. History of visceral organ transplantation.
9. Have uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
10. TBIL (total bilirubin) \> 3.0 mg/dL and serum creatinine (SCr) \> 3.0 mg/dL within 48 hours before surgery may require dialysis.
11. History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension。
12. Pulmonary embolism and pulmonary artery systolic blood pressure exceeding 60mmHg within 3 weeks prior to enrollment combined with at least one of the following 2 parameters demonstrated that pulmonary vascular resistance did not respond to drug therapy: pulmonary vascular resistance greater than 8 wood units; The transpulmonary differential pressure exceeds 20mmHg.
13. Established and untreated abdominal or thoracic aortic aneurysm \> 5cm in diameter.
14. Severe peripheral vascular disease with resting pain or extremity ulceration.
15. Patients with psychiatric disorders/disorders, irreversible cognitive impairment or psychosocial problems are at risk of failing to comply with research protocols and regulations governing the use of implantable LEFT ventricular assist systems or brain death from various causes.
16. Expect to live less than 1 year if you have a malignant tumor or other disease.
17. Patients participate in any other clinical trials that may influence the results of this study.
18. Other circumstances that are unforeseen and determined by the researcher to be unsuitable.

Primary outcomes:
measure: Survival [ Time Frame: 6 months ]
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life (EQ-5D-5L)
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Functional Status - Six Minute Walk Test (6MWT)
timeFrame: [ Time Frame: Baseline, Month 1, Month 3, Month 6 ]
measure: New York Heart Association (NYHA) Classification
timeFrame: Baseline, Month 1, Month 3, Month 6
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline, Month 1, Month 3, Month 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: