Patent Ductus Arteriosus
Conditions
Interventions
Group A:Biodegradable PDA occluder and Delivery System
Group B:PDA occluder and Delivery System
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Weight = 6kg. 2 Aged = 6 months. 3 The diameter of the arterial catheter that needs to be treated is greater than 2 mm. 4 No combined organic pulmonary hypertension. 5 Voluntarily participate in this clinical trial, sign an informed consent form and follow up as required.
Exclusion criteria
Exclusion criteria: 1 Pulmonary hypertension presents as a simple right-left shunt 2 Combined with cardiac malformations requiring surgery. 3 A heart malformation that relies on PDA survival. 4 Patients with structural heart disease other than PDA. 5 Patients with infective endocarditis, heart valves, and neoplasms in the duct. 6 Patients with hemolysis, hemorrhagic disease, unhealed ulcers, or any taboo about aspirin (except being able to take other anti-platelet agent for consecutive 6 months) within one month before implantation. 7 Patients with thrombosis (especially in left atrium or left atrial thrombus) as shown by echocardiography. 8 Patients with known condition of hypercoagulation status. 9 Patients ever received heart operation. 10 Patients with local or systemic sepsis. 11 Patients with untreated systemic infection. 12 Patients that are in pregnancy or lactation, or planned for pregnancy or get a positive pregnancy test result during the screening period (minors without menarche are exempt from this examination). 13 Patients that have participated in any clinical trial that may affect the evaluation of the device in this trial and not completed or withdrawn from the previous clinical trial within 3 months prior to this trial screening period. 14 Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size. 15 Patients are not suitable for cardiac catheterization for other reasons. 16 Referring to the 2017 Chinese expert guideline for the treatment of patent ductus arteriosus, the investigators believe that patients who are not eligible for this clinical trial based on the principle of maximizing the medical benefits of the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Closure success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Closure success rate;Overall success rate;Complication rate; | — |
Countries
China
Contacts
Public ContactSun Kun
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed