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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776956
• Other study ID #: xierqdoctormd
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2017
• Source: The Second Hospital of Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• atorvastatin group
Patients in atorvastatin group will orally receive 20 mg of atorvastatin per night (Pfizer) for three days before the operation and three months after the operation
• non-atorvastatin group
Patients in non-atorvastatin group will not receive atorvastatin before the operation and after the operation.

Locations

Country	Name	City	State
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
xieruiqin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left atrial function of postoperative atrial fibrillation detected		1-12 month
Secondary	Plasma biomarkers of inflammation,myocardial injury and prothrombotic assessed		1-3 month