Trials / Completed
CompletedNCT02985684
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
GORE® CARDIOFORM ASD Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs) - The Gore ASSURED Clinical Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
Detailed description
This is a prospective, multicenter, single-arm clinical study comparing outcomes with the GORE® CARDIOFORM ASD Occluder to performance goals derived from clinical investigation outcomes for devices indicated for ASD closure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GORE® CARDIOFORM ASD Occluder | Percutaneous Atrial Septal Defect Closure |
Timeline
- Start date
- 2017-03-10
- Primary completion
- 2018-07-30
- Completion
- 2022-09-29
- First posted
- 2016-12-07
- Last updated
- 2026-03-17
- Results posted
- 2020-01-07
Locations
22 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02985684. Inclusion in this directory is not an endorsement.