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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Left Atrial Appendage Occlusion
• Intervention / Treatment: Device: intracardiac echocardiography

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • Second Hospital of Hebei Medical University
      • Contact: Xie Ruiqin, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: left atrial appendage radiography	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.; Other Names: left atrial appendage radiography
EXPERIMENTAL: intracardiac echocardiography guidance	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.; Other Names: left atrial appendage radiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Second Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (ACTUAL): August 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Xieruiqin/ICE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No