Study on Left Atrial Function of Atrial Fibrillation Afte... | NCT02776956

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

NCT02776956

Sponsor

xieruiqin

Status

Completed

Last Update Posted

Sep 24, 2019Actual

Enrollment

180Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

atorvastatin group
non-atorvastatin group

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Aug 2018Actual

Completion Date

Aug 2018Actual

First Submitted Date

Apr 29, 2016

First Submission Date that Met QC Criteria

May 18, 2016

First Posted Date

May 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2019

Last Update Posted Date

Sep 24, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

xieruiqin, director of cardiology department, The Second Hospital of Hebei Medical UniversitySponsor-Investigator

Lead Sponsor

xieruiqinOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left atrial function of postoperative atrial fibrillation detected		1-12 month

Secondary Outcomes

Measure	Description	Time Frame
Plasma biomarkers of inflammation,myocardial injury and prothrombotic assessed		1-3 month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Hospital of Hebei Medical University		Shijiazhuang	Hebei	050000	China

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided