Clinical trial NCT02100683: Nit-Occlud PDA Post-Approval Study
Official title: Nit-Occlud PDA Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Ductus Arteriosus (PDA)
Keywords: Occluder
Lead sponsor: PFM Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: Bright Research Partners
First posted: 2014-04-01
Enrollment: 184
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age 6 months to 21 years weighing \>/= 5kg with an angiographically confirmed PDA with a minimum diameter of \<4 mm.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety
timeFrame: 24 months (2 year)
measure: Rate of Complete PDA Closure as a Measure of Efficacy
timeFrame: 12 months (1 year)
Secondary outcomes:
measure: Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety
timeFrame: 24 months (2 year)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Madera
country: United States
facility: Children's Hospital of Central California
state: California
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Children's Hospital
state: Minnesota
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: UCLA Pediatric Cardiology
name: Daniel S Levi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Proposed standards for clinical evaluation of patent ductus arteriosus occlusion devices. Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices. Catheter Cardiovasc Interv. 2000 Nov;51(3):293-6. No abstract available.
citation: Kobayashi D, Salem MM, Forbes TJ, Gordon BM, Soriano BD, Dimas V, Goldstein BH, Owada C, Javois A, Bass J, Jones TK, Berman DP, Gillespie MJ, Moore JW, Levi DS. Results of the combined U.S. multicenter postapproval study of the Nit-Occlud PDA device for percutaneous closure of patent ductus arteriosus. Catheter Cardiovasc Interv. 2019 Mar 1;93(4):645-651. doi: 10.1002/ccd.27995. Epub 2018 Dec 3.