Aortic root changes after percutaneous atrial septal defect closure; Insights towards understanding the mechanism and predictors of device erosion and aortic valve dysfunction.
Completed
- Conditions
- Slight damage to intracardial structures adjacent to the closure device100103941000751010007593
- Registration Number
- NL-OMON43366
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
- Adult (> 18 years)
- Secundum atrial septal defect successfully percutaneously closed in the Academic Medical Center using a single/multiple septal occluder.
- Baseline, procedural and echocardiographic (pre- and intra-procedural) data available.
Exclusion Criteria
- Contraindications to transesophageal echocardiography (TEE).
- Inability to record a good-quality 3D echocardiographic images.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Assessment of the device shape and relation to adjacent atrial/ aortic walls;<br /><br>o Device size, device/defect ratio, device/ septal ratio<br /><br>o Aortic-end shape (flare vs. closed)<br /><br>o Relation to adjacent structures (aorta/atria): non-touch, touch or pressure<br /><br><br /><br>• Retrospective assessment of periprocedural echocardiography before device<br /><br>deployment;<br /><br>o Total septal length(s)/area (3D)<br /><br>o Septal mobility (redundancy)<br /><br>o Septal eccentricity/mal-alignment<br /><br>o Defect size and shape (3D)<br /><br>o Defect expansibility (dynamicity)<br /><br>o Adequacy and consistency of rims<br /><br><br /><br>• Retrospective assessment of periprocedural echocardiography before and after<br /><br>device deployment;<br /><br>o Aortic annular diameters (AP, ML) and eccentricity (systolic and diastolic)<br /><br>o SOV diameters (AP, ML) and eccentricity (systolic and diastolic)<br /><br>o STJ diameters (AP, ML) (systolic and diastolic)</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Aortic valve dimensions and function at long-term follow-up (>= 3 months)<br /><br>after successful ASO implantation.<br /><br>o Planimetered AVA (systolic)<br /><br>o Leaflet *effective height* (systolic)<br /><br>o Aortic annular motion (STE)<br /><br>o Aortic regurgitation (CFM; jet width, VC width and area)</p><br>