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

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.

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Key information

Conditions

Patent Ductus Arteriosus 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IJN National Heart Institute, Kuala Lumpur, Malaysia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with a demonstrated patent ductus arteriosus
Female or male
Belonging to any ethnic group
Age between > 6 months and 70 years
Body weight > 6 kg < 120 kg

Exclusion criteria

Associated congenital cardiac anomalies,
Body weight < 6 Kilograms

General exclusion criteria

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.

Treatment and study plan

Occlutech PDA occluder

Device

Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.

Primary outcomes

Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.

Time frame: 3 months

Secondary outcomes

Successful closure without evidence of residual shunt after 1 year confirmed by echocariodgram. Safety: freedom of major adverse events i.e periherial embolism or endocarditits.

Time frame: 30, 90, 180 and 360 days after implant

Sponsors and collaborators

Lead sponsor

Occlutech International AB

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Nov 24, 2011
Registry last updated: Feb 15, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed