The objective of this clinical research is to evaluate the safety and effectiveness of Implantable Alginate Hydrogel to reconstruct the left ventricle in the treatment of heart failure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Implantable Alginate Hydrogel is a single use, multiple component device. It is expected to be used as a space-occupying material implanted into the myocardium to affect the shape of the left ventricle and reduce the clinical symptoms of patients with left ventricular ischemia and non-ischemic cardiomyopathy. The hydrogel serves as an artificial myocardial filler to stop the continuous expansion of the ventricle and restore it to a more favorable shape and size. The expected clinical effect of the Implanted Alginate Hydrogel is to reduce the clinical symptoms of patients and improve the quality of life by improving the structure and function of the failing heart.
The First Affiliated Hospital of Air Force Military Medical University
Xi’an, Shanxi, China
Rate of Serious Adverse Device Events
Definition of SADE: Any complications related to the device include but not limited: death, stroke, permanent damage to the heart, any situation that requires further intervention, etc.
Time frame: 30 days after implantation
Device successfully Setup rate
Device successfully Setup defined as: 1. The device reaches the expected implant location 2. Implant the hydrogel accurately in the left ventricle wall for 6\~12 implant points. 3. Remove the delivery system
Time frame: immediately after the implantation
Incidence of SAE
Rate of Serious Adverse Events occurred during procedure and follow-up
Time frame: Within 6 months after implantation
NHYA Class level changes rate between baseline and 6 months' follow-up
Time frame: 6 months after implantation
Quality of life changes rate between baseline and 6 months' follow-up
Time frame: 6 months after implantation
Rate of Rehospitalization due to heart failure
Rehospitalization due to heart failure within 6 months after implantation
Time frame: within 6 months after implantation
LVEF changes rate between baseline and 6 months' follow-up
Time frame: 6 months after implantation
Size of LV changes rate between baseline and 6 months' follow-up
Time frame: 6 months after implantation
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