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

NCT ID: NCT02776956

Last Updated: 2019-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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atorvastatin group

atrial fibrillation in atorvastatin group will orally receive atorvastatin before and after operation.

Group Type EXPERIMENTAL

atorvastatin group

Intervention Type DRUG

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

atrial fibrillation in non-atorvastatin group will not receive atorvastatin before and after operation..

Group Type OTHER

non-atorvastatin group

Intervention Type DRUG

Patients in non-atorvastatin group will not receive atorvastatin before the operation and after the operation.

Interventions

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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

Intervention Type DRUG

non-atorvastatin group

Patients in non-atorvastatin group will not receive atorvastatin before the operation and after the operation.

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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xieruiqin

OTHER

Sponsor Role lead

Responsible Party

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xieruiqin

director of cardiology department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Countries

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China

Other Identifiers

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xierqdoctormd

Identifier Type: -

Identifier Source: org_study_id

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