Patent Ductus Arteriosus
Conditions
Interventions
Experimental group:Device Implantation Procedure
Control group:Control device implantation
Sponsors
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Body weight>=4kg; 2. Transthoracic ultrasound/angiography confirmed the presence of patent ductus arteriosus, or combined with one of the following symptoms: (1) left atrial and/or left ventricular enlargement; (2) pulmonary hypertension is manifested by a simple left-to-right shunt; 3. PDA diameter<10mm; 4. Subjects and their families voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Congenital heart disease dependent on the presence of patent ductus arteriosus; 2. Pulmonary hypertension is manifested as a simple right-to-left shunt; 3. The sepsis is not cured, and the patient has a serious infection within 1 month before the closure operation; 4. Infective endocarditis, vegetations in heart valves and ducts; 5. Combined with other cardiac malformations that must be surgically operated; 6. Bleeding disorders or coagulation disorders; 7. Presence of intracardiac thrombosis; 8. Suffering from other diseases that are not suitable for interventional surgery; 9. The investigator considers it unsuitable to participate in this clinical trial; 10. Malignant tumors or other diseases with a life expectancy of less than 2 years; 11. Participated in other drug or medical device clinical trials within the past 90 days and the trial did not meet the primary endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative 180-Day Effective Occlusion Success Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device Implantation Success Rate;PDA Occlusion Success Rate;All-Cause Mortality;Incidence of Severe Left Pulmonary Artery (LPA) or Aortic Obstruction During Follow-up;Incidence of Device-Related Serious Adverse Events (SAEs) During Follow-up;Incidence of Procedure-Related Serious Adverse Events (SAEs) During Follow-up; | — |
Countries
China
Contacts
Public ContactXiangbin Pan
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Outcome results
None listed