N/A
N=1,000
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Atrial Septal Defect
Bottom Line
View on ClinicalTrials.gov: NCT00650936 ↗Enrolled (actual)
1,000
Serious AEs
5.7%
Results posted
Jun 2019
Primary outcome: Primary: Percent of Subjects With Two-year Device-related Hemodynamic Compromise — 0.65 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AMPLATZER Septal Occluder (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects With Two-year Device-related Hemodynamic Compromise |
0.65 | — |
| PRIMARY Co-Primary Effectiveness Endpoint |
97.87 | — |
| PRIMARY Co-Primary Safety Endpoint |
6.34 | — |
Summary
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
Eligibility Criteria
Inclusion Criteria
- Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she:
- is indicated for implantation with the AMPLATZER Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure),
- is willing and able to complete the follow-up requirements of this study, and
- signs the informed consent (or a legal representative signs the informed consent).
Data sourced from ClinicalTrials.gov (NCT00650936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.