ClinicalTrials.Veeva

Menu

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

R

Ruiqin xie

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Procedure: LAAC combined with radiofrequency ablation group
Procedure: Left atrial appendage closure
Procedure: Radiofrequency ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT04376606
XieruiqindoctorLAAC

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

105 participants in 3 patient groups

Left atrial appendage closure group
Experimental group
Treatment:
Procedure: Left atrial appendage closure
Radiofrequency ablation group
Experimental group
Treatment:
Procedure: Radiofrequency ablation
LAAC combined with radiofrequency ablation group
Experimental group
Treatment:
Procedure: LAAC combined with radiofrequency ablation group

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems