Congenital Heart Disease Clinical Trial
Official title:
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R" for Percutaneous Closure of Patent Arterial Duct Between 2 and 8 mm in Patients Treated Interventionally in Specialized Centers
The purpose of this study is to evaluate the safety and the effectiveness of the device "Nit-Occlud® PDA-R" in the percutaneous closure of patent ductus.
During the years 2003 to 2008, the Cardiological Medical Center "Kardiozentrum" evaluated
1136 patients with echocardiographic studies, 14.7% of the patients were diagnosed with
patent arterial duct. The PDA is an abnormal communication between the aorta and pulmonary
artery. Untreated it can rise the intrapulmonary pressure and lead to serious complications
like cardiac insufficiency.
The incidence of ducts as an isolated heart disease is between 3.6 and 7% of all congenital
heart diseases at sea level, and 10 - 14% at high altitude; rising up to 20% in cities at
more than 2.500 m about sea level. The ducts at high altitude are generally wider and larger
than at sea level.
One treatment alternative is a percutaneous transluminal implantation of a permanent implant
which closes the defect. The device under investigation "Nit-Occlud® PDA-R" is developed for
closure of the PDA with a minimal diameter of 2-8 mm.
The device performs the function of generating the defect occlusion by the body itself. The
implant stimulates the body to generate an epithelium over the implant so that the PDA
closes.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Recruiting |
NCT04992793 -
Paediatric Brain Injury Following Cardiac Interventions
|
||
| Recruiting |
NCT05213598 -
Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
|
||
| Completed |
NCT04136379 -
Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
|
||
| Completed |
NCT04814888 -
3D Airway Model for Pediatric Patients
|
||
| Recruiting |
NCT04920643 -
High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery
|
N/A | |
| Completed |
NCT05934578 -
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
|
N/A | |
| Recruiting |
NCT06041685 -
Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia
|
N/A | |
| Recruiting |
NCT05902013 -
Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation
|
N/A | |
| Not yet recruiting |
NCT05687292 -
Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
|
||
| Not yet recruiting |
NCT05524324 -
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
|
N/A | |
| Completed |
NCT02746029 -
Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
|
||
| Completed |
NCT03119090 -
Fontan Imaging Biomarkers (FIB) Study
|
||
| Completed |
NCT02537392 -
Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease
|
N/A | |
| Recruiting |
NCT02258724 -
Swiss National Registry of Grown up Congenital Heart Disease Patients
|
||
| Completed |
NCT01966237 -
Milrinone Pharmacokinetics and Acute Kidney Injury
|
||
| Terminated |
NCT02046135 -
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
|
Phase 2 | |
| Recruiting |
NCT01184404 -
Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery
|
N/A | |
| Completed |
NCT01548950 -
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
|
N/A | |
| Completed |
NCT01821287 -
Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
|
N/A |