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

NCT04524780 | Unknown

• 1 other identifier: Xieruiqin/ICE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Left Atrial Appendage Occlusion

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

left atrial appendage radiography

EXPERIMENTAL

Device: intracardiac echocardiography

intracardiac echocardiography guidance

EXPERIMENTAL

Device: intracardiac echocardiography

Interventions

intracardiac echocardiography DEVICE

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

Also known as: left atrial appendage radiography

intracardiac echocardiography guidance; left atrial appendage radiography

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Central Study Contacts

Xie Ruiqin

CONTACT

13230178060; 13230178060@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-08

Locations

CN (1)