Nit-Occlud PDA Post-Approval Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by PFM Medical, Inc
Sponsor:
Information provided by (Responsible Party):
PFM Medical, Inc
ClinicalTrials.gov Identifier:
NCT02100683
First received: March 27, 2014
Last updated: May 4, 2014
Last verified: May 2014
  Purpose

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.


Condition
Patent Ductus Arteriosus (PDA)

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

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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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: April 2014
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
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.

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.
  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 ClinicalTrials.gov identifier: NCT02100683

Contacts
Contact: Salvadore Palomares, RAC 760 758 8749 spalomares@pfmmedicalusa.com

Locations
United States, California
Loma Linda University Medical Center Not yet recruiting
Loma Linda, California, United States, 92354
Contact: Brent Gordon, MD    909-558-4207    brgordon@llu.edu   
Principal Investigator: Brent Gordon, MD         
Kaiser Permanente Not yet recruiting
Los Angeles, California, United States, 90027
Contact: Morris M Salem, MD    323-783-5310    morris.m.salem@kp.org   
Principal Investigator: Morris M Salem, MD         
Children's Hospital of Central California Not yet recruiting
Madera, California, United States, 93636
Contact: Carl Owada, MD    559-353-5476    cowada@childrenscentralcal.org   
Principal Investigator: Carl Owada, MD         
UCSD Rady Children's Hospital Not yet recruiting
San Diego, California, United States, 92123
Contact: John Moore, MD    858-966-5855    jmoore@rchsd.org   
Principal Investigator: John Moore, MD         
United States, Colorado
Children's Hospital Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Thomas Fagan, MD    720-777-5682    Thomas.Fagan@childrenscolorado.org   
Principal Investigator: Thomas Fagan, MD         
United States, Connecticut
Yale - New Haven Children's Hospital Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Jeremy Asnes, MD       jeremy.asnes@yale.edu   
Principal Investigator: Jeremy Asnes, MD         
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Damien Kenny, MD    312-942-6880    damien_kenny@rush.edu   
Principal Investigator: Damien Kenny, MD         
Sub-Investigator: Ziyad M Hijazi, MD         
Advocate Christ Medical Center Not yet recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Alexander Javois, MD    708-684-5580    alexander.javois@advocatehealth.com   
Principal Investigator: Alexander Javois, MD         
Sub-Investigator: Dhaval Patel, MD         
United States, Kentucky
Kentucky Children's Hospital Heart Clinic Not yet recruiting
Lexington, Kentucky, United States, 40536
Contact: Doug Schneider, MD    859-323-6754    douglas.schneider@uky.edu   
Principal Investigator: Doug Schneider, MD         
United States, Michigan
Children's Hospital of Michigan Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Thomas Forbes, MD    313-745-5835    tforbes@dmc.org   
Principal Investigator: Thomas Forbes, MD         
Sub-Investigator: Daniel Turner, MD         
Sub-Investigator: Srinath Gowda, MD         
United States, Ohio
Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Ralf Holzer, MD    614-722-2537    ralf.holzer@nationwidechildrens.org   
Principal Investigator: Ralf Holzer, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Matt Gillespie, MD    215-590-1790    Gillespie@email.chop.edu   
Principal Investigator: Matt Gillespie, MD         
United States, Texas
Children's Medical Center of Dallas Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Vivian Dimas, MD    214-456-8727    vivian.dimas@childrens.com   
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 Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Thomas K Jones, MD    206-987-2266    thomas.jones@seattlechildrens.org   
Principal Investigator: Thomas K Jones, MD         
Sub-Investigator: Agustin Rubio, MD         
Sub-Investigator: Troy Johnston, MD         
Sponsors and Collaborators
PFM Medical, Inc
Investigators
Principal Investigator: Daniel S Levi, MD UCLA Pediatric Cardiology
  More Information

Publications:
Responsible Party: PFM Medical, Inc
ClinicalTrials.gov Identifier: NCT02100683     History of Changes
Other Study ID Numbers: TP126
Study First Received: March 27, 2014
Last Updated: May 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by PFM Medical, Inc:
Occluder

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 24, 2014