Nit-Occlud PDA Post-Approval Study

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.

Study Overview

• Status: Completed
• Conditions: Patent Ductus Arteriosus (PDA)
• Intervention / Treatment: Device: PDA Coil

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente
    • Madera, California, United States, 93636
      • Children's Hospital of Central California
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Masonic Children's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center of Dallas
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety	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%.	24 months (2 year)
Rate of Complete PDA Closure as a Measure of Efficacy	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).	12 months (1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety	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).	24 months (2 year)

Collaborators and Investigators

• Sponsor: PFM Medical, Inc
• Collaborators: Bright Research Partners
• Investigators: Principal Investigator: Daniel S Levi, MD, UCLA Pediatric Cardiology

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: March 27, 2014
• First Posted (Estimate): April 1, 2014

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Occluder
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Ductus Arteriosus, Patent
• Other Study ID Numbers: TP126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No