NCT02766569

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

May 5, 2016

Last Update Submit

September 8, 2016

Conditions

Atrial Septal Defect

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • number of erosions

    detection of erosions of the atrial wall after ASD closure

    minimum 1 year

Secondary Outcomes (3)

  • number of arrhythmias

    minimum 1 year

  • successful implantation

    minimum 1 year

  • embolization

    minimum 1 year

Interventions

ASD closure with the Occlutech Flex II ASD closure deviceDEVICE

Monitoring of possible device related side effects with a minumum of 1 year follow-up.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients undergoing interventional ASD closure by using the Occlutech Flex II device

You may not qualify if:

  • life expectancy \< 12 months
  • participating in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 Oct;88(4):571-581. doi: 10.1002/ccd.26497. Epub 2016 Mar 31.

    PMID: 27029396BACKGROUND

MeSH Terms

Conditions

Heart Septal Defects, AtrialArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nikolaus A Haas, MD, PhD

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Nikolaus A. Haas

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 10, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

September 9, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share