Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion

Atrial Fibrillation Clinical Trial

Official title:

Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833985
• Other study ID #: TEE vs.ICE vs.fluoroscopy only
• Status: Completed
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: July 2020
• Source: The Second Hospital of Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 1:1:1). 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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 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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• LAAC combined with radiofrequency ablation
Each patient received the same group of patients with simple radiofrequency ablation and LAAC

Locations

Country	Name	City	State
China	Second Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
xieruiqin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	injected contrast media	milliliter	in the procedure
Primary	fluoroscopy time were recorded	mGy	in the procedure
Secondary	the time from femoral vein puncture to transseptal puncture to closure were recorded	second	in the procedure
Secondary	The size of the LAA	millimeter	in the procedure
Secondary	the size of the selected umbrella in operation	millimeter	in the procedure
Secondary	residual shunt and DRT after transcatheter closure of left atrial appendage detected	Transesophageal echocardiography	before operation and 3 months after operation
Secondary	new pericardial effusion were detected	Transthoracic echocardiography	3 months after operation
Secondary	pericardial tamponade were detected	Transthoracic echocardiography	3 months after operation