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Device

GORE® CARDIOFORM ASD Occluder for Atrial Septal Defect (ASSURED Trial)

N/A
Waitlist Available
Led By Matthew Gillespie, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

ASSURED Trial Summary

This study is evaluating whether a device can be used to close a hole in the heart.

Eligible Conditions
  • Atrial Septal Defect

ASSURED Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects With 6-Month Closure Success
Number of Subjects With 6-Month Composite Clinical Success
Secondary outcome measures
Measured Residual Target Defect Size
Medical Devices
Number of Subjects With Clinically Significant New Arrhythmia
+3 more

ASSURED Trial Design

1Treatment groups
Experimental Treatment
Group I: DeviceExperimental Treatment1 Intervention
ASD closure with the GORE® CARDIOFORM ASD Occluder
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GORE® CARDIOFORM ASD Occluder
2017
N/A
~130

Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
95 Previous Clinical Trials
28,059 Total Patients Enrolled
Matthew Gillespie, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
Robert Sommer, MDPrincipal InvestigatorColumbia University of New York
2 Previous Clinical Trials
175 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
2017. "Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02985684.
~15 spots leftby May 2025
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