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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02766569
Other study ID # IRFACODE II
Secondary ID
Status Enrolling by invitation
Phase N/A
First received May 5, 2016
Last updated September 8, 2016
Start date July 2016
Est. completion date December 2017

Study information

Verified date September 2016
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2000
Est. completion date December 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria: ASD for device closure

Exclusion Criteria:

- life expectancy < 12 months

- participating in another study

Study Design

Observational Model: Cohort


Intervention

Device:
ASD closure with the Occlutech Flex II ASD closure device
Monitoring of possible device related side effects with a minumum of 1 year follow-up.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

References & Publications (1)

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 Mar 31. doi: 10.1002/ccd.26497. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary number of erosions detection of erosions of the atrial wall after ASD closure minimum 1 year Yes
Secondary number of arrhythmias detection of arrhythmias after ASD closure minimum 1 year Yes
Secondary successful implantation number of successful device implantations after device was placed inside the heart minimum 1 year No
Secondary embolization number of events of device embolization during Implantation and follow-up minimum 1 year Yes
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