Clinical trial NCT02766569: International Registry for ASD Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients
Official title: International Registry for Secundum Atrial Septal Defects Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Septal Defect
Keywords: IRFACODE II, ASD closure, ASD device, erosion, arrhythmia
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: all patients undergoing interventional ASD closure by using the Occlutech Flex II device

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: ASD for device closure

-

Exclusion Criteria:

* life expectancy \< 12 months
* participating in another study

Primary outcomes:
measure: number of erosions
timeFrame: minimum 1 year
Secondary outcomes:
measure: number of arrhythmias
timeFrame: minimum 1 year
measure: successful implantation
timeFrame: minimum 1 year
measure: embolization
timeFrame: minimum 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Nikolaus A Haas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haas NA, Soetemann DB, Ates I, Baspinar O, Ditkivskyy I, Duke C, Godart F, Lorber A, Oliveira E, Onorato E, Pac F, Promphan W, Riede FT, Roymanee S, Sabiniewicz R, Shebani SO, Sievert H, Tin D, Happel CM. Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series. Catheter Cardiovasc Interv. 2016 Oct;88(4):571-581. doi: 10.1002/ccd.26497. Epub 2016 Mar 31.