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Clareo Health | Nit-Occlud PDA Post-Approval Study

Nit-Occlud PDA Post-Approval Study

NCT02100683·11 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

PFM Medical, Inc

With

Bright Research Partners

Age

0–21

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

Angiographically confirmed PDA with minimum diameter \< 4 mm.
Weight is ≥ 5 kg.
Age 6 months to 21 years.

You may not be if

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.

The record

StatusCompleted

PhaseNo phase

Taking part184

StartedAug 2014

UpdatedOct 4, 2022

Conditions

Patent Ductus Arteriosus (PDA)

Where11

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