Nit-Occlud PDA Post-Approval Study

PFM Medical, Inc184 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

184

Conditions

Patent Ductus Arteriosus (PDA)

Interventions

PDA CoilDEVICE

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

Sex: ALLMin age: 6 MonthsMax age: 21 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

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%.

Time frame: 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).

Time frame: 12 months (1 year)

Secondary Outcomes

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).

Time frame: 24 months (2 year)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.