NCT02776956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 24, 2019

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

April 29, 2016

Last Update Submit

September 21, 2019

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation;left atrial function

Outcome Measures

Primary Outcomes (1)

  • Left atrial function of postoperative atrial fibrillation detected

    1-12 month

Secondary Outcomes (1)

  • Plasma biomarkers of inflammation,myocardial injury and prothrombotic assessed

    1-3 month

Study Arms (2)

atorvastatin group

EXPERIMENTAL

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

Drug: atorvastatin group

non-atorvastatin group

OTHER

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

Drug: non-atorvastatin group

Interventions

atorvastatin groupDRUG

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

atorvastatin group
non-atorvastatin groupDRUG

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

non-atorvastatin group

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director of cardiology department

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 19, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 24, 2019

Record last verified: 2017-08

Locations

CN(1)