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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2022-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The researchers will participate in the operation to record operative parameters. Other researchers including follow-up personnel and the ultrasonic data analyst are uninformed about the random situation of the patients (patient information is recorded according to the random number.Random numbers corresponding to the random allocation list are stored in the research center. After follow-up of the last patient is completed, the random allocation list is published by the random number designer; and the designer does not participate in the data collection and statistics.

Study Groups

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transesophageal echocardiography guidance

Group Type EXPERIMENTAL

LAAC combined with radiofrequency ablation group

Intervention Type PROCEDURE

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

intracardiac echocardiography guidance

Group Type EXPERIMENTAL

LAAC combined with radiofrequency ablation group

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No