Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

Recruiting Observational Study
Patent Ductus Arteriosus
No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Any
Study type
Observational
Participants needed
255 (estimated)
Sponsor
Occlutech International AB · Industry
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About This Trial
This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects with patent ductus arteriosus (PDA) defects. Safety and efficacy assessments include vital signs, electrocardiograms, and echocardiographic evaluations performed at baseline…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * A subject of any age will be eligible for PDA closure if he or she meets the indication and area of application as laid down in the IFU. Including subjects more than 3 kg. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (…
Contacts

Ahmed Dellaa, PhD

+49 3641 508 367

ahmed.dellaa@occlutech.com

CONTACT

Gonul Sonmez Utkun

+90 212 465 04 97

gonul.sonmezutkun@occlutech.com

CONTACT