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Occlutech Septal Occluder (Figulla Flex II) Study

NCT04488120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2020-07-27

No results posted yet for this study

Summary

The objectives of the study are:

* To determine the efficacy of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects
* To determine the safety of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects

This is a randomized, controlled, multi-centre trial of the efficacy and safety of the Occlutech septal occluder (Figulla Flex II) compared to the AGA septal occluder (Amplatzer ASO) for transcatheter closure of secundum atrial septal defects in patients.

Conditions

  • Secundum Atrial Septal Defects

Interventions

DEVICE

transcatheter closure of secundum atrial septal defects in patients

transcatheter closure of secundum atrial septal defects in patients

Sponsors & Collaborators

  • Occlutech International AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-21
Primary Completion
2015-12-23
Completion
2017-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488120 on ClinicalTrials.gov