Clinical trial NCT04134793: Correlation of Atrial Fibrillation Recurrence After Bipolar Radiofrequency Ablation With microRNA Expression
Official title: Correlation of Atrial Fibrillation Recurrence After Bipolar Radiofrequency Ablation With microRNA Expression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation, ablation, microRNA
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study Population include persistent atrial fibrillation with mitral valve stenosis or regurgitation alone. Surgery procedure is mitral valve repair or replacement. Left atrium appendage was harvested for later tissue miRNA study. Six-month follow-up was performed by holter and echocardiography.

Brief summary: The recurrence rate of atrial fibrillation (AF) after bipolar radiofrequency ablation was about 30%. Besides the factors, left atrium diameter, the duration of AF, NT-proBNP, and ejection fraction(EF), some studies demonstrated that the specific microRNA expression (miRNA1, miRNA19,miRNA23, miRNA409 ) showed the significant change in AF patients compared with normal sinus patients, who underwent catheter ablation. Therefore, the correlation of atrial fibrillation recurrence and above-mentioned microRNA after bipolar radiofrequency ablation remained unclear, although bipolar radiofrequency ablation had high rate of sinus.

Detailed description: Numerous studies identify specific microRNA (miRNA) expression profiles associated with atrial fibrillation (AF), changes in plasmamiRNA expression in pre-and post-operativeAFpatients who have received catheterisation . The correlation of atrial fibrillation recurrence and above-mentioned microRNA after bipolar radiofrequency ablation remain poorly characterized.

This study aimed to reveal disease-related biomarkers by detecting plasmamiRNA expression in AF patients, and examining the levels of AF-specific miRNAs in patients after bipolar radiofrequency ablation, in order to help gauge therapeutic effects and assess prognosis.

A total of 50 Han Chinese patients with AF who had received bipolar radiofrequency ablation recruited to the study. Atrial fibrillation-specific plasma miRNAs were detected by sequencing and quantitative reverse transcription polymerase chain reaction. According to AF recurrence rate of about 30%, the expression levels of AF-specific miRNAs were investigated in15 post-operative AF patients and 35 patients with normal sinus after ablation,to explore changes in miRNA expression.

Eligibility criteria: Inclusion Criteria:

persistent atrial fibrillation, with alone mitral valve stenosis or regurgitation

Exclusion Criteria:

left atrium more than 60mm ejection fraction less than 30% complicated with other valve disease of aortic valve stenosis or regurgitation

Primary outcomes:
measure: atrial fibrillation recurrence rate
timeFrame: six months after bipolar radiofrequency ablation
measure: miRNA expression difference
timeFrame: six months after bipolar radiofrequency ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People' Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People' Hospital
name: Xiaoqiang Quan, doctor
role: STUDY_DIRECTOR
References:
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