The primary objective is to investigate the determinants of aortic root deformation occurring >= 3 months after successful ASO implantation in adult patients with an atrial septal defect.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Assessment of the device shape and relation to adjacent atrial/ aortic walls;
o Device size, device/defect ratio, device/ septal ratio
o Aortic-end shape (flare vs. closed)
o Relation to adjacent structures (aorta/atria): non-touch, touch or pressure
• Retrospective assessment of periprocedural echocardiography before device
deployment;
o Total septal length(s)/area (3D)
o Septal mobility (redundancy)
o Septal eccentricity/mal-alignment
o Defect size and shape (3D)
o Defect expansibility (dynamicity)
o Adequacy and consistency of rims
• Retrospective assessment of periprocedural echocardiography before and after
device deployment;
o Aortic annular diameters (AP, ML) and eccentricity (systolic and diastolic)
o SOV diameters (AP, ML) and eccentricity (systolic and diastolic)
o STJ diameters (AP, ML) (systolic and diastolic)
Secondary outcome
• Aortic valve dimensions and function at long-term follow-up (>= 3 months)
after successful ASO implantation.
o Planimetered AVA (systolic)
o Leaflet *effective height* (systolic)
o Aortic annular motion (STE)
o Aortic regurgitation (CFM; jet width, VC width and area)
Background summary
Device erosion is a rare fatal complication of percutaneous atrial septal
defect (ASD) closure using the Amplatzer Septal Occluder (ASO) and the risk of
erosion continues up to years after device implantation. The absolute risk of
erosion after ASO implantation has been estimated to range from 0.043% to
0.5%.1-8 Erosion of ASD closure devices has been linked to different (sometimes
confusing and/or contradicting) risk factors (principally, deficient
aortic/posterior rim). This discrepancy in the number of supposedly susceptible
patients and the actual rate of device erosion precludes a simple direct causal
relationship. The extent of interaction between the implanted device and the
aorta may be described as post-implantation aortic root deformation and may be
detected by transoesophageal echocardiography. Post-implantation aortic root
deformation by the ASO has been reported to be more likely in those with
deficient aortic rim and may be associated with the occurrence of device
erosion. Aortic root deformation could, thus, serve as a surrogate risk marker
for device erosion and exploring its predictors is more practical than
exploring the direct predictors of device erosion.
Study objective
The primary objective is to investigate the determinants of aortic root
deformation occurring >= 3 months after successful ASO implantation in adult
patients with an atrial septal defect.
Study design
Observational cohort study. Patients eligible for the study will undergo a
single transesophageal echocardiogram (TEE) from which aortic root deformation
will be assessed (i.e. by measuring device size/ shape, aortic annular
diameters and eccentricity, among others). Patients* baseline echocardiographic
parameters will be retrospectively studied for predictors of aortic root
deformation (i.e. device/ defect ratio, defect dynamicity and aortic rim among
others).
Study burden and risks
No study-specific benefits and risks are anticipated for the subjects in the
study population.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57822.018.16 |