Incremental value of systematic follow-up with CT after left atrial appendage occluder device implantation

Incremental value of systematic follow-up with CT after left atrial appendage occluder device implantation - follow-up with CT after left atrial appendage occluder device implantation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42544

Enrollment

Registered

2015-08-07

Start date

2015-09-02

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

Artrial appendix trombus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patient accepted for LAAO device implantation. • At least 18 years old • Signed informed consent

Exclusion criteria

Exclusion criteria: • Impaired renal function (serum creatinine > 120 umol/l or GFR

Design outcomes

Primary

Measure	Time frame
Investigate if CT is a reliable modality to detect blood flow distal to the LAAO device validated by TEE.	—

Secondary

Measure	Time frame
Evaluate the reproducibility of position and blood flow measurements: inter and intra observer variance, CT compared with TEE. • Determine the optimal device position and size, based on pre-implantation anatomical CT data. Measurements of the LAA shape, ostium, depth and trabeculations in relation to the LAAO device landing position. When describing the ostium diameters specific attention can be placed on the oval shape as the ability of the device to change it from a circular to an oval shape is limited. • Compare CT findings with clinical follow-up with specific interest for thromboembolic complications. Investigate if these can be related to suboptimal device position, trabeculations at the device landing zone, or contrast enhancement distal to the device. • Size of the LAA distal to the device can be measured and compared to the LAA size as measured before implantation. Possibly allowing for volumetric measurements of thrombus and to determine the ratio of contrast and thrombus distal to the LAAO device.	—

Measure

Time frame

Evaluate the reproducibility of position and blood flow measurements: inter and intra observer variance, CT compared with TEE. • Determine the optimal device position and size, based on pre-implantation anatomical CT data. Measurements of the LAA shape, ostium, depth and trabeculations in relation to the LAAO device landing position. When describing the ostium diameters specific attention can be placed on the oval shape as the ability of the device to change it from a circular to an oval shape is limited. • Compare CT findings with clinical follow-up with specific interest for thromboembolic complications. Investigate if these can be related to suboptimal device position, trabeculations at the device landing zone, or contrast enhancement distal to the device. • Size of the LAA distal to the device can be measured and compared to the LAA size as measured before implantation. Possibly allowing for volumetric measurements of thrombus and to determine the ratio of contrast and thrombus distal to the LAAO device.

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Countries

Netherlands

Outcome results