Clinical trial NCT02776956: Study on Left Atrial Function of Atrial Fibrillation After Radiofrequency Ablation With Statin Therapy
Official title: Study on Left Atrial Function of Atrial Fibrillation After Radiofrequency Ablation With Statin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation;left atrial function
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 180
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 120 patients with persistent atrial fibrillation (including continuous and long-standing persistent atrial fibrillation) and 60 patients with paroxysmal atrial fibrillation will receive radiofrequency ablation. Patients in each group will be randomly allocated into the statin treatment group and non-statin treatment group (allocation ratio, 1:1). Left atrial appendage flow velocity of all patients are measured by Transesophageal Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of left atrial function are carried out for all patients before the operation and after the operation. Blood samples are extracted in all patients before the operation and after the operation. This study will clarify whether the application of statin drugs can improve postoperative left atrial function. This study will identify the time course and influence factors of left atrial recovery of atrial fibrillation after the operation to guide the time and the degree of anticoagulation and effectively prevent thromboembolic events. At the same time, biochemical indicators are detected to analyze which indicators are related to the postoperative recurrence of atrial fibrillation, the incidence of postoperative thrombosis and the recovery of postoperative left atrial function. Furthermore, this study will investigate whether the application of statin drugs can improve postoperative left atrial function by affecting these indicators.


Eligibility criteria: Inclusion Criteria:

* All persistent or permanent AF patients with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.
* paroxysmal atrial fibrillation with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.
* age is \<80 years

Exclusion Criteria:

* left ventricular dysfunction
* LA \>50 mm
* atrial thrombosis
* valvular heart disease
* hyperthyroidism
* patients who underwent prosthetic heart valve replacement
* patients with previous history of atrial fibrillation ablation
* Hyperlipidemia
* pregnant women
* patients with existing liver and kidney disease
* malignant tumors
* hematological system diseases

Primary outcomes:
measure: Left atrial function of postoperative atrial fibrillation detected
timeFrame: 1-12 month
Secondary outcomes:
measure: Plasma biomarkers of inflammation,myocardial injury and prothrombotic assessed
timeFrame: 1-3 month
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
Study officials:
References: