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

Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by by Multimodal Echocardiographic Techniques for Atrial Fibrillation Patients Before and After Radiofrequency Ablation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02838914
Enrollment
80
Registered
2016-07-20
Start date
2015-06-30
Completion date
2019-08-31
Last updated
2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Right atrium, Echocardiography, Remodeling

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.

Interventions

PROCEDUREradiofrequency ablation (RFCA)

Patients undergo radiofrequency ablation (RFCA)

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patientsIn one week before RFCA

Secondary

MeasureTime frame
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patientsIn one week after RFCA
Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patientsAt three months after RFCA
Adverse event that is related to RFCA, such as the incidence of cardiac tamponade (%) was obtained by echocardiographyIn one week after RFCA

Other

MeasureTime frame
Adverse events that are related to RFCA, such as the incidence of pulmonary vein stenosis(%) and embolism(%) were obtained by CTAt six months after RFCA

Countries

China

Contacts

Primary ContactKun Sun, M.D.;Ph.D.
sunkunxh@163.com13651696395
Backup ContactYi Yu, M.D.
yuyi20122012@163.com13817308128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026