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Use of Intracardiac Echocardiography or Left Atrial Appendage Radiography to Guide Implantation of a Left Atrial Appendage Occlusion Device

Not Applicable
Recruiting
Conditions
Left Atrial Appendage Occlusion
Interventions
Device: intracardiac echocardiography
Registration Number
NCT04524741
Lead Sponsor
The Second Hospital of Hebei Medical University
Brief Summary

A total of 40 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. The diameter and depth of the left atrial appendage opening were measured by angiography in group A(ICE group), and measured by ICE in group B(radiography group). The size of the occluder device was selected according to the measurement size of the two groups, the occluder device success rate of the two groups was compared, and the relationship between measurement size and the size of the occluder device was obtained.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
40
Inclusion Criteria

patients taking class I and class III antiarrhythmic drugs could not prevent atrial fibrillation, patients younger than 80 years old Cha2ds2-vasc score ≥2 and Has-bled score ≥3, not suitable for long-term oral anticoagulant drugs.

Exclusion Criteria

Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
left atrial appendage radiographyintracardiac echocardiography-
intracardiac echocardiography guidanceintracardiac echocardiography-
Primary Outcome Measures
NameTimeMethod
record contrast media as well as fluoroscopy time were recordedin the procedure

record contrast media as well as fluoroscopy time were recorded in all patients

measure left atrial appendage opening and depth in different angles by radiographyin the procedure

use left atrial appendage radiography to measure left atrial appendage opening and depth

measure left atrial appendage opening and depth in different angles by intracardiac echocardiographyin the procedure

use intracardiac echocardiography to measure left atrial appendage opening and

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Second Hospital of Hebei Medical University

🇨🇳

Shijiazhuang, Hebei, China

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