NCT04391504

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

Completed NA Last updated 5 May 2022

What this trial tests

NA trial testing LAAC combined with radiofrequency ablation group in Atrial Fibrillation in 60 participants. Completed in 1 April 2022.

Timeline

1 May 2020

Primary endpoint
1 April 2022

1 April 2022

Quick facts

Lead sponsor	Ruiqin xie
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 May 2020
Primary completion	1 April 2022
Estimated completion	1 April 2022
Sites	1 location across China

Drugs / interventions tested

• LAAC combined with radiofrequency ablation group

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Ruiqin xie

Who can join

Adults 18 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Results and Safety of Intracardiac Echocardiography Guidance for Combined Catheter Ablation and Left Atrial Appendage Occlusion.
   Liu Q, You L, Yang J, Zhang Y, et al · · 2024 · cited 4× · PMID 39076324 · DOI 10.31083/j.rcm2506192