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

NCT ID: NCT04833985

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2021-07-31

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 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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

transesophageal echocardiography guidance

Group Type: EXPERIMENTAL

LAAC combined with radiofrequency ablation

Intervention Type: PROCEDURE

Each patient received the same group of patients with simple radiofrequency ablation and LAAC

intracardiac echocardiography guidance

Group Type: EXPERIMENTAL

LAAC combined with radiofrequency ablation

Intervention Type: PROCEDURE

Each patient received the same group of patients with simple radiofrequency ablation and LAAC

fluoroscopy only guidance

Group Type: EXPERIMENTAL

LAAC combined with radiofrequency ablation

Intervention Type: PROCEDURE

Each patient received the same group of patients with simple radiofrequency ablation and LAAC

Interventions

LAAC combined with radiofrequency ablation

Each patient received the same group of patients with simple radiofrequency ablation and LAAC

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

xieruiqin

OTHER

Sponsor Role: lead

Responsible Party

xieruiqin

director of cardiology department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

TEE vs.ICE vs.fluoroscopy only

Identifier Type: -

Identifier Source: org_study_id