Clinical trial NCT04403412: Changes of Left Atrial Function and Quality of Life in Patients With Left Atrial Appendage Occlusion
Official title: Short Term Changes of Left Atrial Function and Quality of Life in Patients With Atrial Fibrillation After Left Atrial Appendage Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
left atrial appendage closure
quality of life assessed
left atrial function
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2020-05-27
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 patients with atrial fibrillation (AF) are scheduled to receive surgical treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC), three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency ablation (1:1:1) were performed respectively. All patients were examined three-dimensional and two-dimensional ultrasound before operation, 1 and 3 months after operation to measure left atrial (LA) function. The routine blood test and high-sensitivity C-reactive protein were performed in all patients before operation, 1 day and 1 month after operation. B-type natriuretic peptide was detected in all patients before operation and 1 day, 1 month and 3 months after operation. All patients underwent 6-minute walking test and quality of life score before operation, 1 and 3 months after operation.

Detailed description: A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC), three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency ablation (1:1:1) were performed respectively. All patients were examined by real-time three-dimensional and two-dimensional ultrasound before operation, 1 and 3 months after operation to measure left atrial (LA) function. All ultrasound data will be stored and the professional director of the ultrasound room will be invited for quantitative analysis. The ultrasound indexes include: left atrial diameter, left atrial ejection fraction, etc. All patients underwent transesophageal echocardiography before operation and 3 months after the operation. Results two experienced ultrasound doctors judged whether there was left atrial thrombus, residual shunt and instrument surface related thrombus. The routine blood test and high-sensitivity C-reactive protein were performed in all patients before operation, 1 day and 1 month after operation. B-type natriuretic peptide was detected in all patients before operation and 1 day, 1 month and 3 months after operation. All patients underwent 6-minute walking test and quality of life score before operation, 1 and 3 months after operation. At the same time, the thickness of crista was measured in all patients. This study will clarify the changes of left atrial function and biochemical quality in patients with AF 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 has more advantages than simple occlusion or ablation, and analyzed the above results. The patients were followed up for an average of three months to analyze the changes of left atrial function, quality of life and embolism events.

Eligibility criteria: Inclusion Criteria:

1. Patients with AF lasting for more than one year;
2. Antiarrhythmic drugs are ineffective;
3. Age of patients is less than 80 years old;
4. Cha2ds2-vasc score ≥ 2;
5. Not suitable for long-term oral anticoagulants.

Exclusion Criteria:

1. Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation);
2. Patients undergoing prosthetic heart valve replacement;
3. Pregnant women;
4. 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- 3 month
measure: changes of 6-minute walking test
timeFrame: 1- 3 month
measure: quality of life assessed
timeFrame: 1- 3 month
Secondary outcomes:
measure: Residual shunt after transcatheter closure of left atrial appendage detected
timeFrame: 1-3 month
measure: device-related thrombus after transcatheter closure of left atrial appendage detected
timeFrame: 1-3 month
measure: C creative protein
timeFrame: 1-3 month
measure: B natriuretic peptide assessed
timeFrame: before and 3 month after operation
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
Study officials:
References: