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Nit-Occlud PDA Post-Approval Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bright Research Partners
Information provided by (Responsible Party):
PFM Medical, Inc
ClinicalTrials.gov Identifier:
NCT02100683
First received: March 27, 2014
Last updated: March 15, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Patent Ductus Arteriosus (PDA) Device: PDA Coil

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: 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 [ Time Frame: 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:
  • Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety [ Time Frame: 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).


Enrollment: 184
Actual Study Start Date: August 2014
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PDA Coil
Patients age 6 months to 21 years weighing > 5kg with an angiographically confirmed PDA with a minimum diameter of < 4 mm.
Device: PDA 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.

  Eligibility

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.
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

Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Kaiser Permanente
Los Angeles, California, United States, 90027
Children's Hospital of Central California
Madera, California, United States, 93636
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55454
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
PFM Medical, Inc
Bright Research Partners
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: March 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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 21, 2017