Study on Left Atrial Function of Atrial Fibrillation After Radiofrequency Ablation With Statin Therapy
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
atorvastatin group
non-atorvastatin group
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation;left atrial function
Eligibility Criteria
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
Sites / Locations
- The Second Hospital of Hebei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
atorvastatin group
non-atorvastatin group
Arm Description
atrial fibrillation in atorvastatin group will orally receive atorvastatin before and after operation.
atrial fibrillation in non-atorvastatin group will not receive atorvastatin before and after operation..
Outcomes
Primary Outcome Measures
Left atrial function of postoperative atrial fibrillation detected
Secondary Outcome Measures
Plasma biomarkers of inflammation,myocardial injury and prothrombotic assessed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02776956
Brief Title
Study on Left Atrial Function of Atrial Fibrillation After Radiofrequency Ablation With Statin Therapy
Official Title
Study on Left Atrial Function of Atrial Fibrillation After Radiofrequency Ablation With Statin Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
xieruiqin
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation;left atrial function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
atorvastatin group
Arm Type
Experimental
Arm Description
atrial fibrillation in atorvastatin group will orally receive atorvastatin before and after operation.
Arm Title
non-atorvastatin group
Arm Type
Other
Arm Description
atrial fibrillation in non-atorvastatin group will not receive atorvastatin before and after operation..
Intervention Type
Drug
Intervention Name(s)
atorvastatin group
Intervention Description
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
Intervention Name(s)
non-atorvastatin group
Intervention Description
Patients in non-atorvastatin group will not receive atorvastatin before the operation and after the operation.
Primary Outcome Measure Information:
Title
Left atrial function of postoperative atrial fibrillation detected
Time Frame
1-12 month
Secondary Outcome Measure Information:
Title
Plasma biomarkers of inflammation,myocardial injury and prothrombotic assessed
Time Frame
1-3 month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study on Left Atrial Function of Atrial Fibrillation After Radiofrequency Ablation With Statin Therapy
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