Changes of Left Atrial Function and Quality of Life After Transcatheter Closure of Left Atrial Appendage in Patients With Atrial Fibrillation

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

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2022-09-28

Brief Summary

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A total of 105 (AF) patients with atrial fibrillation are scheduled to undergo surgery and will be divided into three groups. Left atrial appendage occlusion ((LAAC)), radiofrequency ablation guided by three-dimensional mapping and LAAC combined with radiofrequency ablation were performed respectively (allocation ratio 1:1:1). All patients were examined by real-time three-dimensional and two-dimensional ultrasound before operation and 3, 6 and 12 months after operation, and the (LA) function of left atrium was measured. All ultrasound data will be stored and the professional director of the ultrasound room will be invited to conduct quantitative analysis. Ultrasonic examination indexes include: anterior and posterior diameter of left atrium, left atrial ejection fraction and so on. All patients underwent transesophageal echocardiography before and 3 months after operation. The results were interpreted by 2 experienced ultrasound doctors to measure the presence of left atrial thrombus, residual shunt and device-related thrombus. Blood samples were taken to detect B-type natriuretic peptide before operation, 1 day, 3-6 months and 12 months after operation. All patients underwent 6-minute walking test and quality of life score before operation and 3, 6 and 12 months after operation. At the same time, the thickness of crest in all patients was measured during operation. This study will clarify the changes of left atrial function and quality of life in patients with atrial fibrillation after LAAC. In addition, this study also observed the effect of radiofrequency ablation combined with LAAC on left atrial function and evaluated whether one-stop surgery was superior to simple occlusion or ablation, and the above results were analyzed. The patients were followed up for an average of one year, and the changes of left atrial function, quality of life and embolic events were analyzed.

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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 105 patients with persistent atrial fibrillation(AF), who are persistented more than one year and planned to undergo surgical treatment, will be allocated into two groups. These patients will receive left atrial appendage closure, radiofrequency ablation under the guidance of 3D mapping and left atrial appendage closure combined with radiofrequency ablation, respectively (allocation ratio, 1:1:1)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The researchers will participate in the operation to record operative parameters such as LA pressure. 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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Left atrial appendage closure group

Group Type EXPERIMENTAL

Left atrial appendage closure

Intervention Type PROCEDURE

Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography

Radiofrequency ablation group

Group Type EXPERIMENTAL

Radiofrequency ablation

Intervention Type PROCEDURE

Each patient with persistent AF receives circumferential pulmonary vein isolation under the 3D electro-anatomical mapping system , and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation.

LAAC combined with radiofrequency ablation group

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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Left atrial appendage closure

Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography

Intervention Type PROCEDURE

Radiofrequency ablation

Each patient with persistent AF receives circumferential pulmonary vein isolation under the 3D electro-anatomical mapping system , and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation.

Intervention Type PROCEDURE

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