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Nit-Occlud PDA Post-Approval Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by PFM Medical, Inc
Bright Research Partners
Information provided by (Responsible Party):
PFM Medical, Inc Identifier:
First received: March 27, 2014
Last updated: October 25, 2016
Last verified: October 2016
This study is an FDA post-approval study of the Nit-Occlud PDA Device to evaluate 5 year (60 months) safety and effectiveness of the device.

Patent Ductus Arteriosus (PDA)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nit-Occlud PDA Post-Approval Study

Resource links provided by NLM:

Further study details as provided by PFM Medical, Inc:

Primary Outcome Measures:
  • Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety [ Time Frame: 5 year (60 months) ]
    The primary safety endpoint is to demonstrate that the 60 months (5 year) serious device and/or procedure 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 [ Time Frame: 60 months (5 year) ]
    The primary effectiveness endpoint is to demonstrate that the 60 month (5 year) complete closure rate for the device is no worse than an OPC of 85%. The closure of the ductus arteriosus will be assessed by absence of residual flow at 60 months (5 years) by transthoracic echocardiogram with 2-D color of color flow mapping and pulse wave Doppler (ECHO).

Secondary Outcome Measures:
  • Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety [ Time Frame: 60 months (5 year) ]
    The secondary safety endpoint is to demonstrate that the rate of device and/or procedure related adverse events reported through 60 months (5 years) post procedure is no worse that 6% (OPC rate of 3% plus an added 3% margin).

  • Rate of Echocardiographic Closure as a Measure of Efficacy [ Time Frame: 36 months (3 year) ]
    The secondary effectiveness endpoint is to demonstrate echocardiographic closure at 12 and 36 months is no worse than an OPC of 85%.

Estimated Enrollment: 215
Study Start Date: August 2014
Estimated Study Completion Date: August 2023
Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02100683

Contact: Martin Sellers, BS 760 7588749
Contact: Andrea Abbs, BS

United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Brent Gordon, MD    909-558-4207   
Principal Investigator: Brent Gordon, MD         
Kaiser Permanente Recruiting
Los Angeles, California, United States, 90027
Contact: Morris M Salem, MD    323-783-5310   
Principal Investigator: Morris M Salem, MD         
Children's Hospital of Central California Recruiting
Madera, California, United States, 93636
Contact: Carl Owada, MD    559-353-5476   
Principal Investigator: Carl Owada, MD         
Sub-Investigator: Paolo Aquino, MD         
United States, Illinois
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Alexander Javois, MD    708-684-5580   
Principal Investigator: Alexander Javois, MD         
Sub-Investigator: Dhaval Patel, MD         
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Thomas Forbes, MD    313-745-5835   
Principal Investigator: Thomas Forbes, MD         
Sub-Investigator: Daniel Turner, MD         
Sub-Investigator: Diasuke Kobayashi, MD         
United States, Minnesota
University of Minnesota Masonic Children's Hospital Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: John L Bass, MD    612-626-2755   
Principal Investigator: John L Bass, MD         
Sub-Investigator: Gurumurthy Hiremath, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Bryan Goldstein, MD    513-636-7072   
Principal Investigator: Bryan Goldstein, MD         
Sub-Investigator: Russell Hirsch, MD         
Sub-Investigator: Wendy Whiteside, MD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Darren Berman, MD    614-722-2537   
Principal Investigator: Darren Berman, MD         
Sub-Investigator: Sharon L Cheatham, PhD, ACNP-BC         
Sub-Investigator: John P Cheatham, MD         
Sub-Investigator: Aimee Armstrong, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Matt Gillespie, MD    215-590-1790   
Principal Investigator: Matt Gillespie, MD         
Sub-Investigator: Andrew Glatz, MD         
Sub-Investigator: Jonathan Rome, MD         
United States, Texas
Children's Medical Center of Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Vivian Dimas, MD    214-456-8727   
Principal Investigator: Vivian Dimas, MD         
Sub-Investigator: Thomas Zellers, MD         
Sub-Investigator: Alan Nugent, MD         
Sub-Investigator: Suren Reddy, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Thomas K Jones, MD    206-987-2266   
Principal Investigator: Thomas K Jones, MD         
Sub-Investigator: Agustin Rubio, MD         
Sub-Investigator: Troy Johnston, MD         
Sub-Investigator: Brian Morray, MD         
Sponsors and Collaborators
PFM Medical, Inc
Bright Research Partners
Principal Investigator: Daniel S Levi, MD UCLA Pediatric Cardiology
  More Information

Responsible Party: PFM Medical, Inc Identifier: NCT02100683     History of Changes
Other Study ID Numbers: TP126 
Study First Received: March 27, 2014
Last Updated: October 25, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by PFM Medical, Inc:

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities processed this record on February 27, 2017