Changes of Left Atrial Function and Quality of Life After Transcatheter Closure of Left Atrial Appendage in Patients With Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Procedure: Left atrial appendage closureProcedure: Radiofrequency ablationProcedure: LAAC combined with radiofrequency ablation group
- Registration Number
- NCT04376606
- Lead Sponsor
- Ruiqin xie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Left atrial appendage closure group Left atrial appendage closure - Radiofrequency ablation group Radiofrequency ablation - LAAC combined with radiofrequency ablation group LAAC combined with radiofrequency ablation group -
- Primary Outcome Measures
Name Time Method Left atrial function of postoperative left atrial appendage occlusion detected 1-12 months Transthoracic echocardiography
quality of life score test 1-12 months quality of life assessed
6-minute walking test 1-12 months quality of life assessed
- Secondary Outcome Measures
Name Time Method residual shunt and DRT after transcatheter closure of left atrial appendage detected 1-12 months Transesophageal echocardiography
B natriuretic peptide assessed 1-12 months Blood samples are extracted in all patients to detected
Trial Locations
- Locations (1)
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China