Nit-Occlud PDA Post-Approval Study | Clinical Trial

Key information

Conditions

Patent Ductus Arteriosus (PDA) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

6 month–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University Medical Center, Loma Linda, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PDA Coil

Device

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.

Primary outcomes

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 outcomes

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).

Sponsors and collaborators

Lead sponsor

PFM Medical, Inc

Industry

Collaborators

Bright Research Partners

Registry information

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2022
First posted: Apr 1, 2014
Registry last updated: Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed