Clinical Trials Logo
  1. Home
  2. Atrial Septal Defect
  3. NCT02766569

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

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

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).

Clinical Trial 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

Observational Model: Cohort

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02766569
Study type Observational [Patient Registry]
Source Ludwig-Maximilians - University of Munich
Contact
Status Enrolling by invitation
Phase N/A
Start date July 2016
Completion date December 2017
View Details
See also
  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 NCT06344494 - Cardiac Interventional ICE Imaging Trial N/A
Not yet recruiting NCT05887700 - Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
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
Recruiting NCT06298344 - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease Early Phase 1
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