Aortic root changes after percutaneous atrial septal defect closure; Insights towards understanding the mechanism and predictors of device erosion and aortic valve dysfunction.

Aortic root changes after percutaneous atrial septal defect closure; Insights towards understanding the mechanism and predictors of device erosion and aortic valve dysfunction. - ARCADE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43366

Enrollment

Registered

2016-10-25

Start date

2017-01-31

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Slight damage to intracardial structures adjacent to the closure device

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Contraindications to transesophageal echocardiography (TEE). - Inability to record a good-quality 3D echocardiographic images.

Design outcomes

Primary

Measure	Time frame
• 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)	—

Measure

Time frame

• 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

Measure	Time frame
• 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)	—

Countries

Netherlands

Outcome results