Clinical trial NCT04376606: Changes of Left Atrial Function and Quality of Life After Transcatheter Closure of Left Atrial Appendage in Patients With Atrial Fibrillation
Official title: Changes of Left Atrial Function and Quality of Life After Transcatheter Closure of Left Atrial Appendage in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
left atrial appendage closure
left atrial function
quality of life
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Left atrial function of postoperative left atrial appendage occlusion detected
timeFrame: 1-12 months
measure: 6-minute walking test
timeFrame: 1-12 months
measure: quality of life score test
timeFrame: 1-12 months
Secondary outcomes:
measure: residual shunt and DRT after transcatheter closure of left atrial appendage detected
timeFrame: 1-12 months
measure: B natriuretic peptide assessed
timeFrame: 1-12 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
Study officials:
References: