First in Man Study of Implantable Alginate Hydrogel

NCT ID: NCT04781660

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-01-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implantable Alginate Hydrogel

All patients will be treated with Implantable Alginate Hydrogel

Group Type: EXPERIMENTAL

Implantable Alginate Hydrogel

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ling Tao, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Air Force Military Medical University

Locations

The First Affiliated Hospital of Air Force Military Medical University

Xi’an, Shanxi, China

Countries

China

Other Identifiers

DK/CQ/CM-001-CIP-01

Identifier Type: -

Identifier Source: org_study_id