Nit-Occlud PDA Post-Approval Study

Completed

• Conditions: Patent Ductus Arteriosus (PDA)

• Registration Number: NCT02100683
• Lead Sponsor: PFM Medical, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-01
• Study Start: 2014-08
• Primary Completion: 2019-11-20
• Study Completion: 2022-08-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Serious Device and/or Procedure Related Adverse Events as a Measure of Safety	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	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

Name	Time	Method
Rate of Device and/or Procedure Related Adverse Events as a Measure of Safety	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).

Trial Locations

Locations (11)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Kaiser Permanente; 🇺🇸 Los Angeles, California, United States

Children's Hospital of Central California; 🇺🇸 Madera, California, United States

Advocate Christ Medical Center; 🇺🇸 Oak Lawn, Illinois, United States

Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States

University of Minnesota Masonic Children's Hospital; 🇺🇸 Minneapolis, Minnesota, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Medical Center of Dallas; 🇺🇸 Dallas, Texas, United States

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