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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: radiofrequency ablation (RFCA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02838914

XH-16-006

Details and patient eligibility

About

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)

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

patients with AF

Experimental group

Description:

Before radiofrequency ablation (RFCA)

Treatment:

Procedure: radiofrequency ablation (RFCA)

Assigned Comparisons

Experimental group

Description:

After radiofrequency ablation (RFCA)

Treatment:

Procedure: radiofrequency ablation (RFCA)