Comprehensive CT-guided vs Echo-fluoroscopy-guided Strategy in the Left Atrial Appendage Occlusion

NCT04913207 | Unknown DMC

• 1 other identifier: LAAO-3DCT
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in patients with nonvalvular atrial fibrillation (AF). Transesophageal echocardiography (TEE) and fluoroscopy were used to measure the maximal diameters of LAA. However, the LAA maximal diameters measured on Two dimensional (2D) views could be limited due to the morphology of LAA varies with each individua. Three dimension computed tomography angiography technology (3D-CTA) is based on cardiac computed tomography angiography (CCTA). The 3D-CTA technology provides an innovative measuring method of LAA to guide the selection of device size, and the best fluoroscopy view to implant device. This measuring method and guideline have never been reported and its role in LAAO is uncertain

Conditions

Cardiology

Outcome Measures

Primary Outcomes (1)

• the rate of success at first device selected

  the device selected successfully at first time during LAAO

  In the procedure of LAAO

Study Arms (2)

Traditional echo-fluoroscopy guided group

SHAM COMPARATOR

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.

Procedure: method of device size selection

3D-CTA guided group

EXPERIMENTAL

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.

Procedure: method of device size selection

Interventions

method of device size selection PROCEDURE

device size selection based on 3D-CTA

3D-CTA guided group; Traditional echo-fluoroscopy guided group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of atrial fibrillation Disease
• 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

You may not qualify if:

• GFR \<50 mL/min/1.73 m2
• Thrombus in LA and LAA

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Study Officials

• HJ LUO

  Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital

  STUDY CHAIR

Central Study Contacts

JUN PU, Doctor

CONTACT

+86 13817577592; pujun310@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 4, 2021
• Study Start: August 1, 2020
• Primary Completion: August 1, 2023
• Study Completion: December 31, 2023
• Last Updated: June 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)