First in Man Study of Implantable Alginate Hydrogel

NCT04781660 | Unknown

• 1 other identifier: DK/CQ/CM-001-CIP-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Keywords

caused by ischemic cardiomyopathy; caused by non-ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Device successfully Setup rate

  immediately after the implantation

• 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

• Rate of Rehospitalization due to heart failure

  within 6 months after implantation

Study Arms (1)

Implantable Alginate Hydrogel

EXPERIMENTAL

All patients will be treated with Implantable Alginate Hydrogel

Device: Implantable Alginate Hydrogel

Interventions

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.

Implantable Alginate Hydrogel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Military Medical University

Xi’an, Shanxi, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ling Tao, Professor

  The First Affiliated Hospital of Air Force Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: April 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)