Clinical trial NCT04781660: First in Man Study of Implantable Alginate Hydrogel
Official title: A Clinical Research for Safety and Feasibility of Implantable Alginate Hydrogel as a Method of Left Ventricular Restoration in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: caused by ischemic cardiomyopathy
caused by non-ischemic cardiomyopathy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. The patients must have been able and willing to give written informed consent
2. The patients should be adult (age≥ 18 years and \<75 years) males or females
3. The patients must have been on stable, evidence-based therapy for HF
4. The Patients have a LVEF ≤35%
5. NYHA is classified as grade III or IV
6. 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:

1. Have undergone any therapeutic traumatic heart surgery within 30 days.
2. Hemodynamic instability or cardiogenic shock.
3. Right-sided HF.
4. Patients who presented with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis.
5. History of Constrictive pericarditis.
6. History of stroke (within 60 days prior to the surgical procedure).
7. History of myocardial infarction (within 30 days prior to the surgical procedure).
8. An LV wall thickness of the LV free-wall, at the mid-ventricular level, of \< 6 mm.
9. Serum creatinine \> 2.0 mg/dL, or calculate creatinine clearance rate \<25 mL/min
10. 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.
11. 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.
12. A life expectancy of \< 1 year due to comorbidities .
13. Unfit for the minimal invasive treatment.

Primary outcomes:
measure: Rate of Serious Adverse Device Events
timeFrame: 30 days after implantation
Secondary outcomes:
measure: Device successfully Setup rate
timeFrame: immediately after the implantation
measure: Incidence of SAE
timeFrame: Within 6 months after implantation
measure: NHYA Class level changes rate between baseline and 6 months' follow-up
timeFrame: 6 months after implantation
measure: Quality of life changes rate between baseline and 6 months' follow-up
timeFrame: 6 months after implantation
measure: Rate of Rehospitalization due to heart failure
timeFrame: within 6 months after implantation
measure: LVEF changes rate between baseline and 6 months' follow-up
timeFrame: 6 months after implantation
measure: Size of LV changes rate between baseline and 6 months' follow-up
timeFrame: 6 months after implantation
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Air Force Military Medical University
state: Shanxi
Study officials:
affiliation: The First Affiliated Hospital of Air Force Military Medical University
name: Ling Tao, Professor
role: PRINCIPAL_INVESTIGATOR
References: