Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833985
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2021-03-29
Brief Title:
Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion
Sponsor:
xieruiqin
Organization:
The Second Hospital of Hebei Medical University
Study Overview
Official Title:
Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A total of 75 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation which were divided into 3 groups The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography and fluoroscope only respectively allocation ratio 111 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 and fluoroscopy only 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 The purpose of this study was to evaluate the feasibility safety and effectiveness of intracardiac echocardiographic ICE-guided and transesophageal echocardiographic TEE-guided and fluoroscopy only-guided left atrial appendage occlusion combined with radiofrequency ablation The average follow-up time is 3 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None