Atrial Septal Defect Clinical Trial
Official title:
International Registry for Secundum Atrial Septal Defects Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients
The IRFACODE II study will evaluate the performance and safety of the Occlutech® Flex II device in patients with closure of secundum atrial septal defects (ASD II).
Introduction: Interventional ASD closure is generally a safe procedure with only a small
amount of severe side effects including mainly erosion of the atrial wall, embolizations and
arrhythmias. The IRFACODE study has shown excellent results in Patients with various
generations of the Occlutech devices. IRFACODE II study will evaluate the performance and
safety of the Occlutech® Flex II device in patients with closure of secundum atrial septal
defects (ASD II).
Methods: The IRFACODE II study is a retrospective, non-randomized open access study for
centres with a minimum of about 50 patients to evaluate the safety and side effects of ASD
closure with this device. A minimum of 2000 patients that have an ASD II closed with this
device until 31. June 2016 will be enrolled, the follow-up will be until 31. June 2017.
Primary outcome measures for safety are the amount of erosions over a minimum follow-up time
of 12 months. Primary outcome measures for device performance will include the success of
complete ASD closure. Secondary outcome measures for safety will include the technique of
implantation, the success rate in anatomically difficult ASDs, the incidence of arrhythmias
(AV block, atrial fibrillation or flutter), device embolization, embolic events or migraine.
A subgroup analysis according to patients age and anatomy of the defect will be performed.
Outlook: The IRFACODE II study is the first trial intended to detect the actual incidence of
erosion after ASD closure using the Flex II device. Although the trial is primarily designed
to study the safety and device performance, the incidence of other potential side effects
will be also evaluated.
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Observational Model: Cohort
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