Corheart 6 LVAS LTFU

NCT05928273 | Completed

• 1 other identifier: COREMED_LVAD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Heart Failure

Outcome Measures

Primary Outcomes (1)

• Survival [ Time Frame: 6 months ]

  Patients survived with the device for at least 6 months without disabling stroke (disabling stroke disabling stroke defined as a mRS Score \> 3 at 60 days after stroke) and without reoperation (replacement or removal) due to device problems.

  6 months

Secondary Outcomes (4)

• Quality of Life (EQ-5D-5L)

  Baseline, Month 1, Month 3, Month 6

• Functional Status - Six Minute Walk Test (6MWT)

  [ Time Frame: Baseline, Month 1, Month 3, Month 6 ]

• New York Heart Association (NYHA) Classification

  Baseline, Month 1, Month 3, Month 6

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Baseline, Month 1, Month 3, Month 6

Study Arms (1)

Corheart 6 LVAS

EXPERIMENTAL

Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) to be used on patients with advanced refractory heart failure.

Device: Corheart 6 Left Ventricular Assist System

Interventions

Corheart 6 Left Ventricular Assist System DEVICE

Implantation of left ventricular assist device for hemodynamic support

Corheart 6 LVAS

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patient or legal representative has signed Informed Consent Form (ICF)
• BSA ≥ 1.0 m2
• Females of child bearing age must agree to use adequate contraception
• 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)
• LVEF ≤ 30%,and at least one of the following conditions occurs:
• 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;
• Rely on continuous intravenous administration of one or more cardioactive drugs or positive inotropic drugs;
• Meeting diagnostic criteria of cardiogenic shock: blood pressure \< 90/60mmHg; Cardiac discharge index \< 2.0; Pulmonary capillary wedge pressure \> 18mmHg

You may not qualify if:

• Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy,pericardial disease, amyloidosis or restrictive cardiomyopathy.
• Active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
• In the investigator's judgment, there are technical difficulties that lead to an unacceptable hig surgical risk.
• 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.
• Patients require biventricular assist device support.
• Pregnancies.
• 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.
• History of visceral organ transplantation.
• Have uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
• TBIL (total bilirubin) \> 3.0 mg/dL and serum creatinine (SCr) \> 3.0 mg/dL within 48 hours before surgery may require dialysis.
• History of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension。
• 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.
• Established and untreated abdominal or thoracic aortic aneurysm \> 5cm in diameter.
• Severe peripheral vascular disease with resting pain or extremity ulceration.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

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: March 17, 2023
• First Posted: July 3, 2023
• Study Start: December 20, 2021
• Primary Completion: July 10, 2022
• Study Completion: January 17, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)