Status:
UNKNOWN
Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD
Lead Sponsor:
Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions:
Patent Ductus Arteriosus
Duct-dependent Cyanotic Congenital Heart Disease
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
This is a pilot study on feasibility, efficacy and safety of IBS ® for implantation in the PDA in duct-dependent cyanotic CHD, and its objective is to investigate the feasibility, safety and efficacy ...
Detailed Description
Study type: Interventional, prospective, single arm, investigator initiated Study population: 10 patients Primary purpose: Treatment Follow up: Review at 1 month and thereafter 3 monthly (clinical exa...
Eligibility Criteria
Inclusion
- Weight \>3.0 kg
- Age \<3 months
- Patients with uncomplicated PDA morphology (the PDA is not tortuous i.e. relatively straight
Exclusion
- Weight \<3 kg, age \>3 months
- Angiographic criteria-tortuous PDA
- Family history of diseases related to iron overload or iron disorder e.g. hereditary hemochromatosis
- Other severe congenital anomalies with life expectancy \<12 months
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04291222
Start Date
December 11 2018
End Date
August 1 2021
Last Update
March 2 2020
Active Locations (1)
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1
Institut Jantung Negara
Kuala Lumpur, Malaysia