Status:
UNKNOWN
Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents
Lead Sponsor:
John Paul II Hospital, Krakow
Conditions:
Dilated Cardiomyopathy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Clinical evaluation of the CIRCULATE catheter involves intracoronary administration of a typical medical agent (nitroglycerin) and a shown-to-be-safe cell-based agent (CardioCell) in patients with a d...
Detailed Description
The use of adult stem cells from several sources has been shown to improve cardiac function in acute and chronic cardiac disease. Several sources of adult stem cells have been identified including bon...
Eligibility Criteria
Inclusion
- Diagnosis of DCM
- Left ventricular ejection fraction (LVEF) ≤ 45% by echocardiography
- Signed informed consent
Exclusion
- Less than 3 months from any substantial cardiac therapeutic intervention (such as, e.g. CRT/ICD fitting)
- Less than 3 months from acute coronary syndrome
- BMI lower than 18 or greater than 45kg/m2
- Severe valvular heart disease or left ventricle aneurysm requiring aneurysmectomy or other structural interventions
- Present candidate for heart transplantation
- Active or any history of malignancy or tumor
- Moderate or severe immunodeficiency
- Chronic immunosuppressive therapy
- Acute or chronic infection
- Coagulopathies
- Known alcohol or drug dependence
- Severe renal dysfunction (eGFR\<20mL/min)
- Soft tissue disease or local infection in a place of required artery puncture
- Pregnancy or breastfeeding
- Females of childbearing potential who do not use a highly effective method of contraception, and in absence of a negative highly sensitive urine or serum pregnancy test
- Participation in any other clinical research study that has not reached its primary efficacy endpoint or otherwise would interfere with the patient's participation in this project
- Life expectancy \<12 months
- Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04703751
Start Date
September 1 2022
End Date
November 1 2022
Last Update
August 11 2022
Active Locations (1)
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1
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, Maloplska, Poland, 31-202