Patent Ductus Arteriosus (PDA)
Conditions
Keywords
Occluder
Brief summary
The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.
Interventions
DEVICEPDA Coil
The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter \< 4 mm.
Sponsors
Bright Research Partners
PFM Medical, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 21 Years
Healthy volunteers
No
Inclusion criteria
* Angiographically confirmed PDA with minimum diameter \< 4 mm. * Weight is ≥ 5 kg. * Age 6 months to 21 years.
Exclusion criteria
* Cardiac anomalies requiring surgery. * Known bleeding or coagulation disorder. * Febrile illness within 7 days of planned procedure. * Pregnancy. * Pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 Wood Units). * Hypersensitivity to contrast medium. * Known nickel allergy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety | 24 months (2 year) | The primary safety endpoint is to demonstrate the 24-month serious device-related adverse event rate is no worse than the objective-performance criterion (OPC) of 1%. |
| Rate of Complete PDA Closure as a Measure of Efficacy | 12 months (1 year) | The primary effectiveness endpoint is to demonstrate the 12-month (1 year) complete closure rate for the device is no worse than the OPC of 85%. The closure of the ductus arteriosus will be assessed by absence of residual flow at 12 months (1 year) by transthoracic echocardiogram with 2-D color flow mapping and pulse wave Doppler (ECHO). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety | 24 months (2 year) | The secondary safety endpoint is to demonstrate that the rate of device-related adverse events reported through 24-months post procedure is no worse than 6% (OPC rate of 3% plus an added 3% margin). |
Countries
United States
Outcome results
None listed