First in Man Study of Implantable Alginate Hydrogel

Not Applicable

• Conditions: Heart Failure
• Interventions: Device: Implantable Alginate Hydrogel

• Registration Number: NCT04781660
• Lead Sponsor: Xijing Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Last Update Submitted: 2021-03-01
• Study First Posted: 2021-03-04
• Last Update Posted: 2021-03-04
• Study Start: 2021-04-01
• Primary Completion: 2022-02-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantable Alginate Hydrogel	Implantable Alginate Hydrogel	All patients will be treated with Implantable Alginate Hydrogel

Primary Outcome Measures

Name	Time	Method
Rate of Serious Adverse Device Events	30 days after implantation	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

Name	Time	Method
Size of LV changes rate between baseline and 6 months' follow-up	6 months after implantation
Incidence of SAE	Within 6 months after implantation	Rate of Serious Adverse Events occurred during procedure and follow-up
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
Device successfully Setup rate	immediately after the implantation	Device successfully Setup defined as: 1. The device reaches the expected implant location; 2. Implant the hydrogel accurately in the left ventricle wall for 6\~12 implant points.; 3. Remove the delivery system
Rate of Rehospitalization due to heart failure	within 6 months after implantation	Rehospitalization due to heart failure within 6 months after implantation
LVEF changes rate between baseline and 6 months' follow-up	6 months after implantation

Trial Locations

Locations (1)

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