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

Xijing Hospital1 site in 1 country10 target enrollmentApril 1, 2021

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Xijing Hospital
Enrollment: 10
Locations: 1
Primary Endpoint: Rate of Serious Adverse Device Events
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 1, 2021

End Date

January 1, 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xijing Hospital

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Rate of Serious Adverse Device Events

Time Frame: 30 days after implantation

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.

Secondary Outcomes

Incidence of SAE(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)
Size of LV changes rate between baseline and 6 months' follow-up(6 months after implantation)
Device successfully Setup rate(immediately after the implantation)
Rate of Rehospitalization due to heart failure(within 6 months after implantation)
LVEF changes rate between baseline and 6 months' follow-up(6 months after implantation)