First in Man Study of Implantable Alginate Hydrogel

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04781660
• Other study ID #: DK/CQ/CM-001-CIP-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2021
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: January 1, 2023
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Air Force Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of SAE	Rate of Serious Adverse Events occurred during procedure and follow-up	Within 6 months after implantation
Secondary	NHYA Class level changes rate between baseline and 6 months' follow-up		6 months after implantation
Secondary	Quality of life changes rate between baseline and 6 months' follow-up		6 months after implantation
Secondary	Rate of Rehospitalization due to heart failure	Rehospitalization due to heart failure within 6 months after implantation	within 6 months after implantation
Secondary	LVEF changes rate between baseline and 6 months' follow-up		6 months after implantation
Secondary	Size of LV changes rate between baseline and 6 months' follow-up		6 months after implantation