Trials / Terminated
TerminatedNCT02353351
ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 602 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)
Detailed description
This study will enroll 8000 subjects. The sub-cohort will consist of 160 (2%) subjects, randomly selected from the full cohort. The analysis population will consist of all subjects in the sub-cohort, combined with all subjects with erosion events who are not in the sub-cohort. A detailed assessment of risk factors will be conducted on the subjects in this analysis population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | atrial septal occluder | Single arm atrial septal defect closure with the AMPLATZER Septal Occluder |
Timeline
- Start date
- 2015-01-19
- Primary completion
- 2017-02-24
- Completion
- 2017-02-24
- First posted
- 2015-02-02
- Last updated
- 2019-02-04
Locations
65 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02353351. Inclusion in this directory is not an endorsement.