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OpenTrials
Completed

NCT Number: NCT02776956

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

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.

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Key information

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin group

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

Drug

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

Primary outcomes

  1. Left atrial function of postoperative atrial fibrillation detected

    Time frame: 1-12 month

Secondary outcomes

  1. Plasma biomarkers of inflammation,myocardial injury and prothrombotic assessed

    Time frame: 1-3 month

Sponsors and collaborators

Lead sponsor

xieruiqin

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 19, 2016
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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