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Correlation of Atrial Fibrillation Recurrence After Bipolar Radiofrequency Ablation With microRNA Expression

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ClinicalTrials.gov Identifier: NCT04134793
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Jian Zhao, Henan Institute of Cardiovascular Epidemiology

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: radiofrequency ablation

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Correlation of Atrial Fibrillation Recurrence After Bipolar Radiofrequency Ablation With microRNA Expression
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sinus group
Six-month follow-up, by holter ECG record,the patients keep normal sinus after atrial fibrillation radiofrequency ablation.
Procedure: radiofrequency ablation
bipolar radiofrequency ablation by ablation forceps

atrial fibrillation recurrence group
Six-month follow-up, by holter ECG record,the patients again suffer from atrial fibrillation after atrial fibrillation radiofrequency ablation.
Procedure: radiofrequency ablation
bipolar radiofrequency ablation by ablation forceps




Primary Outcome Measures :
  1. atrial fibrillation recurrence rate [ Time Frame: six months after bipolar radiofrequency ablation ]
    Holter ECG record

  2. miRNA expression difference [ Time Frame: six months after bipolar radiofrequency ablation ]
    miRNA-1, miRNA-19, miRNA-23, miRNA-29,miRNA-409,


Biospecimen Retention:   Samples With DNA
microRNA from left atrium appendage


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134793


Contacts
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Contact: Jian Zhao, dOCTOR 037158681065 doctorzhao66@126.com
Contact: Leilei Zhang, doctor

Locations
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China, Henan
Henan Provincial People' Hospital
Zhengzhou, Henan, China, 450003
Sponsors and Collaborators
Henan Institute of Cardiovascular Epidemiology
Investigators
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Study Director: Xiaoqiang Quan, doctor Henan Provincial People' Hospital
Publications:

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Responsible Party: Jian Zhao, associate professor, Henan Institute of Cardiovascular Epidemiology
ClinicalTrials.gov Identifier: NCT04134793    
Other Study ID Numbers: HenanICE201901
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jian Zhao, Henan Institute of Cardiovascular Epidemiology:
atrial fibrillation, ablation, microRNA
Additional relevant MeSH terms:
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Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes