First in Man Study of Implantable Alginate Hydrogel

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Heart Failure

Treatments: Device: Implantable Alginate Hydrogel

Study type: Interventional

Funder types: Other

Identifiers

NCT04781660

DK/CQ/CM-001-CIP-01

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Implantable Alginate Hydrogel

Experimental group

Description:

All patients will be treated with Implantable Alginate Hydrogel

Treatment:

Device: Implantable Alginate Hydrogel