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First in Man Study of Implantable Alginate Hydrogel

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Implantable Alginate Hydrogel

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring caused by ischemic cardiomyopathy, caused by non-ischemic cardiomyopathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital of Air Force Military Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implantable Alginate Hydrogel

Arm Description

All patients will be treated with Implantable Alginate Hydrogel

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Incidence of SAE

Rate of Serious Adverse Events occurred during procedure and follow-up

NHYA Class level changes rate between baseline and 6 months' follow-up

Quality of life changes rate between baseline and 6 months' follow-up

Rate of Rehospitalization due to heart failure

Rehospitalization due to heart failure within 6 months after implantation

LVEF changes rate between baseline and 6 months' follow-up

Size of LV changes rate between baseline and 6 months' follow-up

Full Information

NCT ID

NCT04781660

First Posted

March 1, 2021

Last Updated

March 1, 2021

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04781660

Brief Title

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2021 (Anticipated)

Primary Completion Date

February 1, 2022 (Anticipated)

Study Completion Date

January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

caused by ischemic cardiomyopathy, caused by non-ischemic cardiomyopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Implantable Alginate Hydrogel

Arm Type

Experimental

Arm Description

All patients will be treated with Implantable Alginate Hydrogel

Intervention Type

Device

Intervention Name(s)

Implantable Alginate Hydrogel

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of Serious Adverse Device Events

Description

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.

Time Frame

30 days after implantation

Secondary Outcome Measure Information:

Title

Device successfully Setup rate

Description

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

Time Frame

immediately after the implantation

Title

Incidence of SAE

Description

Rate of Serious Adverse Events occurred during procedure and follow-up

Time Frame

Within 6 months after implantation

Title

NHYA Class level changes rate between baseline and 6 months' follow-up

Time Frame

6 months after implantation

Title

Quality of life changes rate between baseline and 6 months' follow-up

Time Frame

6 months after implantation

Title

Rate of Rehospitalization due to heart failure

Description

Rehospitalization due to heart failure within 6 months after implantation

Time Frame

within 6 months after implantation

Title

LVEF changes rate between baseline and 6 months' follow-up

Time Frame

6 months after implantation

Title

Size of LV changes rate between baseline and 6 months' follow-up

Time Frame

6 months after implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ling Tao, Professor

Organizational Affiliation

The First Affiliated Hospital of Air Force Military Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Air Force Military Medical University

City

Xi'an

State/Province

Shanxi

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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First in Man Study of Implantable Alginate Hydrogel

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