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

Left Atrial Appendage Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04524780
• Other study ID #: Xieruiqin/ICE
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2021
• Source: The Second Hospital of Hebei Medical University
• Contact: Xie Ruiqin
• Phone: 13230178060
• Email: 13230178060[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A total of 60 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Left Atrial Appendage Occlusion

Intervention

Device:
• intracardiac echocardiography
30 patients use intracardiac echocardiography to guide left atrial appendage occluder device, 30 patients use radiography to guide left atrial appendage occluder device.

Locations

Country	Name	City	State
China	Second Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	record contrast media as well as fluoroscopy time were recorded	record contrast media as well as fluoroscopy time were recorded in all patients	in the procedure
Primary	measure left atrial appendage opening and depth in different angles by intracardiac echocardiography	use intracardiac echocardiography to measure left atrial appendage opening and depth	in the procedure
Primary	measure left atrial appendage opening and depth in different angles by radiography	use left atrial appendage radiography to measure left atrial appendage opening and depth	in the procedure