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NCT01711983 · ClinicalTrials.gov registry record · NA

Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects

A NA study, sponsored by W.L.Gore & Associates.

Completed
Registry status
NA
Development phase
400
Enrollment target

NCT01711983 is a NA study that has completed, run by W.L.Gore & Associates. The registered enrollment target is 400 participants.

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The verdict

NCT01711983, a NA study, has completed, sponsored by W.L.Gore & Associates.

COMPLETED
Registry status
NA
Development phase
400 participants
Enrollment target

Study Summary

The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.

Interventions

  • DEVICE GORE® CARDIOFORM Septal Occluder

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2012-10
Est. Completion 2018-11-26
Phase NA

Sponsor

W.L.Gore & Associates

53 total trials

What the Registry Record Tells You About NCT01711983

The ClinicalTrials.gov registry entry for NCT01711983 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is W.L.Gore & Associates, which has 53 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which GORE® CARDIOFORM Septal Occluder is the first listed.

NCT01711983 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01711983 about?

NCT01711983 is a clinical study titled "Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects". The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to o...

What is the current status of trial NCT01711983?

This trial is currently completed. It is a NA study. The enrollment target is 400 participants. The study started on 2012-10. Estimated completion is 2018-11-26.

What interventions are being tested in trial NCT01711983?

The interventions under investigation include: GORE® CARDIOFORM Septal Occluder (DEVICE).

Who is sponsoring clinical trial NCT01711983?

This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.