International Registry for ASD Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients

Atrial Septal Defect Clinical Trial

— IRFACODE-II  

Official title:

International Registry for Secundum Atrial Septal Defects Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02766569
• Other study ID #: IRFACODE II
• 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

Related Conditions & MeSH terms

• Atrial Septal Defect
• Heart Septal Defects
• Heart Septal Defects, Atrial

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