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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01479218

Enrollment

Registered

2011-11-24

Start date

2011-11-30

Completion date

2014-05-31

Last updated

2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus

Brief 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.

Interventions

DEVICEOcclutech PDA occluder

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 70 Years

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 General

Design outcomes

Primary

Measure	Time frame
Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.	3 months

Secondary

Measure	Time frame
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.	30, 90, 180 and 360 days after implant

Countries

Malaysia, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026