Short Term Changes of Left Atrial Function and Quality of Life in Patients With Atrial Fibrillation After Left Atrial Appendage Occlusion
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- quality of life assessed
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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.)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with AF lasting for more than one year;
- •Antiarrhythmic drugs are ineffective;
- •Age of patients is less than 80 years old;
- •Cha2ds2-vasc score ≥ 2;
- •Not suitable for long-term oral anticoagulants.
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.
Outcomes
Primary Outcomes
quality of life assessed
Time Frame: 1- 3 month
Shot Form 36 Health Survey Questionnaire：the higher the patient's score, the better the quality of life
changes of 6-minute walking test
Time Frame: 1- 3 month
6-minute walking test in meter
Left atrial function of postoperative left atrial appendage occlusion detected
Time Frame: 1- 3 month
Transthoracic ultrasound
Secondary Outcomes
- Residual shunt after transcatheter closure of left atrial appendage detected(1-3 month)
- device-related thrombus after transcatheter closure of left atrial appendage detected(1-3 month)
- C creative protein(1-3 month)
- B natriuretic peptide assessed(before and 3 month after operation)
Investigators
Ruiqin xie
director of cardiology department
The Second Hospital of Hebei Medical University