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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Patent Ductus Arteriosus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PDA Occluder

single arm

Group Type OTHER

Occlutech PDA occluder

Intervention Type DEVICE

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

Interventions

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Occlutech PDA occluder

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No