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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus | Clinical Trials | Clareo Health

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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

NCT01479218•Occlutech International AB

View on ClinicalTrials.gov

Summary

The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.

Eligibility

Age

0 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with a demonstrated patent ductus arteriosus
•2. Female or male
•3. Belonging to any ethnic group
•4. Age between \> 6 months and 70 years
•5. Body weight \> 6 kg \< 120 kg

Exclusion Criteria

•1. Associated congenital cardiac anomalies,
•2. Body weight \< 6 Kilograms
•presence of a known coagulation disorder
•thrombus at the position allocated for the implantation
•a vein thrombosis in the blood vessels chosen for the introducing system
•an active infection
•Nitinol intolerance (nickel or titanium)
•contrast medium intolerance
•patients who have a vascular system which is too small to admit the required sheath
•patients with pulmonary hypertension and pulmonary-vascular resistance of \>8 Woods Units or a lung - / systemic resistance (PR/SR) of \>0.4.

Locations (2)

IJN National Heart Institute

Kuala Lumpur, Malaysia

Pediatric Hospital no 2

Hochiminh City, Vietnam

Key Dates

Start Date

November 1, 2011

Primary Completion Date

February 1, 2014

Completion Date

May 1, 2014

Last Updated

February 15, 2024

Enrollment

ACTUAL participants

Conditions

Patent Ductus Arteriosus

Interventions

Occlutech PDA occluder

DEVICE

PDA for Kidneys Study

NCT06658496

Patent Ductus ArteriosusCongenital Heart Disease

View study

RECRUITINGEARLY_PHASE1

The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease

NCT06298344

Congenital Heart DiseaseThiamine Deficiency+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Inclusion Criteria

Exclusion Criteria

PDA for Kidneys Study

The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease

The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates

Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems

Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA

Canadian National PDA Treatment Study