Intracardiac Versus Transesophageal Echocardiography for Left Atrial Appendage Occlusion Combined With Radiofrequency Ablation

A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography 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. All patients underwent transesophageal echocardiography before and 3 months after operation, and the results were explained by two experienced ultrasound doctors to measure the presence of left atrial thrombus, residual shunt and device-related thrombus. All patients were examined by transthoracic echocardiography 3 months after operation to evaluate new pericardial effusion, pericardial tamponade, instrument embolization / displacement and so on. The baseline clinical and surgical features and hospitalization outcomes of patients guided by ICE and TEE were recorded and compared. Clinical endpoints include death, new pericardial effusion that does not require pericardiocentesis, tamponade with pericardiocentesis, instrument embolism / displacement, bleeding at the entry site, thromboembolic events (stroke / transient ischemic attack [TIA]), and renal failure requiring dialysis. The purpose of this study was to evaluate the feasibility, safety and effectiveness of intracardiac echocardiographic (ICE)-guided and transesophageal echocardiographic (TEE)-guided left atrial appendage occlusion combined with radiofrequency ablation. And try to analyze whether intracardiac echocardiography can be used as an alternative to transesophageal echocardiography in transcatheter closure of left atrial appendage. The average follow-up time was 1 year.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: LAAC combined with radiofrequency ablation group

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

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • Second Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

sustained AF attack occurred in patients with a duration of more than one year, patients taking class I and class III antiarrhythmic drugs could not prevent AF, patients younger than 80 years old Cha2ds2-vasc score ≥2, 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 Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transesophageal echocardiography guidance	Procedure: LAAC combined with radiofrequency ablation group; Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening
Experimental: intracardiac echocardiography guidance	Procedure: LAAC combined with radiofrequency ablation group; Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
injected contrast media as well as fluoroscopy time were recorded	injected contrast media as well as fluoroscopy time were recorded in all patients	in the procedure
the time from femoral vein puncture to transseptal puncture to closure were recorded	the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients	in the procedure
residual shunt and DRT after transcatheter closure of left atrial appendage detected	Transesophageal echocardiography	1-12months
new pericardial effusion, pericardial tamponade were detected	Transthoracic echocardiography	1-12months

Collaborators and Investigators

• Sponsor: Ruiqin xie

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: atrial fibrillation; intracardiac echocardiography; transesophageal echocardiography; left atrial appendage closure combined with radiofrequency ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: XieruiqindoctorLAA

Drug and device information, study documents

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