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

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Unknown status

CT.gov ID

NCT02766569

Collaborator

(none)

2,000

Enrollment

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Atrial Septal Defect	Device: ASD closure with the Occlutech Flex II ASD closure device

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Official Title:

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

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Outcome Measures

Primary Outcome Measures

number of erosions [minimum 1 year]
detection of erosions of the atrial wall after ASD closure

Secondary Outcome Measures

number of arrhythmias [minimum 1 year]
detection of arrhythmias after ASD closure
successful implantation [minimum 1 year]
number of successful device implantations after device was placed inside the heart
embolization [minimum 1 year]
number of events of device embolization during Implantation and follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: ASD for device closure

Exclusion Criteria:

life expectancy < 12 months
participating in another study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Investigators

Principal Investigator: Nikolaus A Haas, MD, PhD, Ludwig-Maximilians - University of Munich

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Prof. Dr. Nikolaus Haas, MD, PhD, FRACP, Prof. Dr. Nikolaus A. Haas, Ludwig-Maximilians - University of Munich

ClinicalTrials.gov Identifier:

NCT02766569

Other Study ID Numbers:

IRFACODE II

First Posted:

May 10, 2016

Last Update Posted:

Sep 9, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Prof. Dr. Nikolaus Haas, MD, PhD, FRACP, Prof. Dr. Nikolaus A. Haas, Ludwig-Maximilians - University of Munich

IRFACODE II, ASD closure, ASD device, erosion, arrhythmia

Additional relevant MeSH terms:

Heart Septal Defects

Heart Septal Defects, Atrial

Study Results

No Results Posted as of Sep 9, 2016