MedTrace Logo

Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study

NCT04291898 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-06

No results posted yet for this study

Summary

This is a proposal, for the first time in Canada, to examine the comparative effectiveness of three commercially available devices (ASO, FSO, and GAO/GSO) for transcatheter closure of atrial septal defects (ASD) in adults using a pilot randomized controlled trial.

Conditions

  • Atrial Septal Defect

Interventions

DEVICE

AMPLATZER™ Septal Occluder.

Implantation of the AMPLATZER™ Septal Occluder in the ASD.

DEVICE

Occlutech Figulla Flex II®

Implantation of the Occlutech Figulla Flex II® in the ASD.

DEVICE

GORE® CARDIOFORM ASD Occluder

Implantation of the GORE® CARDIOFORM ASD Occluder or GORE® CARDIOFORM Septal Occluder in the ASD.

Sponsors & Collaborators

  • Montreal Heart Institute

    collaborator OTHER

  • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    collaborator OTHER

  • St. Paul's Hospital, Canada

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Eric Horlick, MD · University Health Network, Peter Munk Cardiac Centre

  • Lusine Abrahamyan, MD, PhD · University Health Network, Theta Collaborative

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-23
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • Canada

Study Locations

More Related Trials

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 NCT04291898 on ClinicalTrials.gov