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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantable Alginate Hydrogel | Experimental | All patients will be treated with Implantable Alginate Hydrogel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Alginate Hydrogel | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Device successfully Setup rate | Device successfully Setup defined as:
| immediately after the implantation |
| Incidence of SAE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ling Tao, Professor | The First Affiliated Hospital of Air Force Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Air Force Military Medical University | Xi’an | Shanxi | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
Rate of Serious Adverse Events occurred during procedure and follow-up |
| Within 6 months after implantation |
| NHYA Class level changes rate between baseline and 6 months' follow-up | 6 months after implantation |
| Quality of life changes rate between baseline and 6 months' follow-up | 6 months after implantation |
| Rate of Rehospitalization due to heart failure | Rehospitalization due to heart failure within 6 months after implantation | within 6 months after implantation |
| LVEF changes rate between baseline and 6 months' follow-up | 6 months after implantation |
| Size of LV changes rate between baseline and 6 months' follow-up | 6 months after implantation |