Nit-Occlud PDA Post-Approval Study
- Conditions
- Patent Ductus Arteriosus (PDA)
- Interventions
- Device: PDA Coil
- Registration Number
- NCT02100683
- Lead Sponsor
- PFM Medical, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
- Angiographically confirmed PDA with minimum diameter < 4 mm.
- Weight is ≥ 5 kg.
- Age 6 months to 21 years.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PDA Coil PDA Coil Patients age 6 months to 21 years weighing \> 5kg with an angiographically confirmed PDA with a minimum diameter of \< 4 mm.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (11)
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Children's Hospital of Central California
🇺🇸Madera, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
University of Minnesota Masonic Children's Hospital
🇺🇸Minneapolis, Minnesota, United States