Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by Multimodal Echocardiographic Techniques

Not Applicable

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: radiofrequency ablation (RFCA)

• Registration Number: NCT02838914
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

The purpose of the study is to assess the reconstruction and inverse reconstruction in right atrium by speckle tracking echocardiography combined with real-time three dimensional echocardiography for atrial fibrillation patients before and after radiofrequency ablation (RFCA)

Detailed Description

The prevalence of atrial fibrillation (AF) has increased in recent years. The construction and function of right atrium haven't shown clearly before and after radiofrequency ablation (RFCA).The purpose of the study is to investigate whether RFCA can lead to inverse reconstruction of right atrium for atrial fibrillation patients, which diagnosing by speckle tracking echocardiography combined with real-time three dimensional echocardiography. All patients will be followed up for 12 months.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-07-17
• Study First Posted: 2016-07-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-16
• Last Update Posted: 2018-12-19
• Primary Completion: 2019-05
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. With a history of paroxysmal Af (PAF) and PAF record within 6 months prior to ablation, confirming at least one of the following findings: AF lasting for ≥30 s recorded in Holter or 12-lead ECG.
2. No response to more than one antiarrhythmic drug, or unwilling to receive longterm drug treatment.
3. Can provide informed consent form expressing willingness to participate in the study and comply with follow-up tests and evaluation procedures.
4. Aged 18-80 years.

Exclusion Criteria

1. With acute diseases, such as acute phase after myocardial infarction (within 3 months), within 3 months after acute heart failure or new cerebral infarction;
2. In the list of heart transplantation;
3. Expected survival less than 1 year;
4. With other hemorrhagic diseases and anticoagulant therapy is not allowed;
5. Thrombosis in left atrium;
6. Heart failure, New York Heart Association(NYHA) III/IV or eject fraction(EF)<40%;
7. Patients with uncontrolled cancer;
8. Significant hepatic or renal impairment (and/or alanine transaminase(ALT) or Aspartate transaminase(AST) >2 times upper limit of normal, creatinine clearance rate(CCr)<50%);
9. Previous catheter radiofrequency ablation for AF or cardiac surgery;
10. Pregnant and lactating women, women who plan to become pregnant, or women of child bearing age not using reliable contraceptive measures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assigned Comparisons	radiofrequency ablation (RFCA)	After radiofrequency ablation (RFCA)
patients with AF	radiofrequency ablation (RFCA)	Before radiofrequency ablation (RFCA)

Primary Outcome Measures

Name	Time	Method
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients	In one week before RFCA

Secondary Outcome Measures

Name	Time	Method
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients	In one week after RFCA
Adverse event that is related to RFCA, such as the incidence of cardiac tamponade (%) was obtained by echocardiography	In one week after RFCA
Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients	At six months after RFCA

Trial Locations

Locations (1)

Xinhua Hospital,Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China