Comprehensive CT-guided vs Echo-fluoroscopy-guided Strategy in the Left Atrial Appendage Occlusion
NCT ID: NCT04913207
Last Updated: 2021-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
310 participants
INTERVENTIONAL
2020-08-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Traditional echo-fluoroscopy guided group
LAA angiography is performed with a 6F pigtail catheter in LAA at the view of RAO 30°, CAU 20° and RAO 30°, CRA 20°. Next, the outline of the LAA will be drawn on the screen according to the LAA angiography. LAmbre device size selection is based on diameters of LAA ostium and landing zone measured on LAA angiography. The process of device implantation, assessment, releasing will be carried out at RAO 30°, CAU 20°. TEE is used to check whether the residual peri-device leaks is less than 5mm. The device will be released if it passes the 'COST' standard; otherwise readjusting the implantation position, change the device size and even re-puncturing transseptal to achieve a better axis will be proceeded.
method of device size selection
device size selection based on 3D-CTA
3D-CTA guided group
Patients in 3D-CTA based perimeter group will undergo CCTA examination before LAAO and a 3D model of the left atrium is reconstructed by a workstation. LAmbre device size selection is based on perimeters of LAA ostium and landing zone which are obtained by the measurement method shown previously in this protocol. After transseptal puncture, LAA angiography is performed with a 6F pigtail catheter in LAA at the tangent angle view which is obtained preoperatively by 3D-CCTA. Then, the outline of the LAA will be drawn on the screen according to the LAA angiography. The process of device implantation, assessment, releasing will be carried out at this tangent angle view. TEE is used to check whether the residual peri-device leaks is less than 5mm. The device will be released if it passes the 'COST' standard; otherwise readjusting the implantation position, change the device size and even re-puncturing transseptal to achieve a better axis will be proceeded.
method of device size selection
device size selection based on 3D-CTA
Interventions
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method of device size selection
device size selection based on 3D-CTA
Eligibility Criteria
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Inclusion Criteria
* Age \>18years
* CHA2DS2-VASc scores ≥ 2
* And at least one of the following indications: (a) HAS- BLED scores ≥ 3; (b) intolerance to long-term OAC; (c) stroke, TIA or thromboembolism even under OAC treatment
Exclusion Criteria
* Thrombus in LA and LAA
18 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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HJ LUO
Role: STUDY_CHAIR
Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital
Locations
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Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LAAO-3DCT
Identifier Type: -
Identifier Source: org_study_id
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