Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by W.L.Gore & Associates.
NCT01711983 is a NA study that has completed, run by W.L.Gore & Associates. The registered enrollment target is 400 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: 1. Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder 2. Safety Success: * Freedom from any Serious Adverse Event (SAE) through 30 days post-procedure * Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedur
Interventions
- DEVICE GORE® CARDIOFORM Septal Occluder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2012-10 |
| Est. Completion | 2018-11-26 |
| Phase | NA |
What the finished NCT01711983 record still lists
NCT01711983 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which GORE® CARDIOFORM Septal Occluder is the first listed.
NCT01711983 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01711983's enrollment target sits among peer trials
400 246th of 2000 higher than 1,734 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01665326 · 400 participants
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease
- NCT02108054 · 400 participants · NA
Behavioral and Functional Task Development, Implementation, and Testing
- NCT02216500 · 400 participants · NA
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
- NCT02250352 · 400 participants
Core Biopsies for Establishing a Breast Tumor Tissue Repository
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia