First in Man Study of Implantable Alginate Hydrogel

Study Overview
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Brief Summary
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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

Official Title
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A Clinical Research for Safety and Feasibility of Implantable Alginate Hydrogel as a Method of Left Ventricular Restoration in Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Implantable Alginate Hydrogel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients must have been able and willing to give written informed consent The patients should be adult (age≥ 18 years and <75 years) males or females The patients must have been on stable, evidence-based therapy for HF The Patients have a LVEF ≤35% NYHA is classified as grade III or IV If female, the patients must have been (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of the study device. Exclusion Criteria: Have undergone any therapeutic traumatic heart surgery within 30 days. Hemodynamic instability or cardiogenic shock. Right-sided HF. Patients who presented with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis. History of Constrictive pericarditis. History of stroke (within 60 days prior to the surgical procedure). History of myocardial infarction (within 30 days prior to the surgical procedure). An LV wall thickness of the LV free-wall, at the mid-ventricular level, of < 6 mm. Serum creatinine > 2.0 mg/dL, or calculate creatinine clearance rate <25 mL/min Clinically significant liver enzyme abnormalities, i.e., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2 times the upper limit of normal and/or bilirubin more than 50% above the upper limit of normal. Had been receiving concurrently an investigational product in another clinical trial or had received an investigational product in another clinical trial in the 30 days prior to enrollment. A life expectancy of < 1 year due to comorbidities . Unfit for the minimal invasive treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantable Alginate Hydrogel<br>All patients will be treated with Implantable Alginate Hydrogel | Device: Implantable Alginate Hydrogel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device successfully Setup rate | Device successfully Setup defined as: The device reaches the expected implant location Implant the hydrogel accurately in the left ventricle wall for 6 12 implant points. Remove the delivery system | immediately after the implantation | 
| Incidence of SAE | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caused by ischemic cardiomyopathy, caused by non-ischemic cardiomyopathy