Study on Left Atrial Function of Atrial Fibrillation After Radiofrequency Ablation With Statin Therapy

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: atorvastatin group; Drug: non-atorvastatin group

• Registration Number: NCT02776956
• Lead Sponsor: xieruiqin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-19
• Status Verified: 2017-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2019-09-21
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atorvastatin group	atorvastatin group	atrial fibrillation in atorvastatin group will orally receive atorvastatin before and after operation.
non-atorvastatin group	non-atorvastatin group	atrial fibrillation in non-atorvastatin group will not receive atorvastatin before and after operation..

Primary Outcome Measures

Name	Time	Method
Left atrial function of postoperative atrial fibrillation detected	1-12 month

Secondary Outcome Measures

Name	Time	Method
Plasma biomarkers of inflammation,myocardial injury and prothrombotic assessed	1-3 month

Trial Locations

Locations (1)

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China