Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluatio… (NCT05353816) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
China50 participantsStarted 2022-01-26
Plain-language summary
This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (1) Age ≥ 18 years.
* (2) The patient or legal representative has signed the Informed Consent Form (ICF).
* (3) Body Surface Area (BSA) ≥ 1.0 m\^2.
* (4) Females of childbearing 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) Left Ventricular Ejection Fraction (LVEF) ≤ 30%, and at least one of the following conditions occurs:
* a. Fail to be reversed by or be weaned from intra-aortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO), or other short-term mechanical circulatory support;
* b. Rely on continuous intravenous administration of one or more vasoactive or inotropic drugs;
* c. Meeting the diagnostic criteria of cardiogenic shock: blood pressure \< 90/60mmHg, cardiac index \< 2.0 L/min/m\^2, and 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) Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
* (3) Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
* (4) Intolerance to anticoagulant or antiplatelet therapies or any other peri/posto…
What they're measuring
1
The success rate of device implantation at 3 months.
Timeframe: Up to 3 months post-implantation.
2
The event-free survival at 24 months post-implantation.