First in Man Study of Implantable Alginate Hydrogel

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

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

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Device: Implantable Alginate Hydrogel

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China
      • The First Affiliated Hospital of Air Force Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Implantable Alginate Hydrogel; All patients will be treated with Implantable Alginate Hydrogel

Device: Implantable Alginate Hydrogel; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Ling Tao, Professor, The First Affiliated Hospital of Air Force Military Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): February 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (ACTUAL): March 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: caused by ischemic cardiomyopathy; caused by non-ischemic cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: DK/CQ/CM-001-CIP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No