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.
;
Observational Model: Cohort
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01120964 -
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04950192 -
Philips Intracardiac Echocardiography (ICE) Clinical Registry
|
||
Completed |
NCT02621528 -
Lifetech CeraFlex™ Post-Market Surveillance Study
|
N/A | |
Recruiting |
NCT04291898 -
Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study
|
N/A | |
Terminated |
NCT01773252 -
Right to Left Cardiac Shunt Detection
|
Phase 3 | |
Not yet recruiting |
NCT05887700 -
Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
|
||
Not yet recruiting |
NCT06344494 -
Cardiac Interventional ICE Imaging Trial
|
N/A | |
Recruiting |
NCT06298344 -
The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease
|
Early Phase 1 | |
Recruiting |
NCT06431178 -
General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients
|
N/A | |
Active, not recruiting |
NCT04105595 -
Post Market Registry of the CBSO
|
||
Recruiting |
NCT05688670 -
Regional Anesthesia Following Pediatric Cardiac Surgery
|
Phase 4 | |
Active, not recruiting |
NCT02739087 -
Radiation-Free Heart Catheterization Using MRI
|
N/A | |
Recruiting |
NCT02097758 -
Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
|
N/A | |
Completed |
NCT02985684 -
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
|
N/A | |
Completed |
NCT06139679 -
Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study
|
||
Recruiting |
NCT05540769 -
Holter and ECG Changes After Transcatheter Closure Of ASD In Children
|
N/A | |
Recruiting |
NCT04096924 -
A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
|
N/A | |
Completed |
NCT02957201 -
The Effect on EPCs by Successful Cardiac Occlusion Device Implantation
|
N/A | |
Recruiting |
NCT02453451 -
The Effect of the Hole in the Cardiac Septum Developed by the MitraClip Procedure on the Blood Flow Mechanics
|
N/A | |
Completed |
NCT00498446 -
Magnetic Resonance Imaging of Atrial Septal Defects
|