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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04134793
• Other study ID #: HenanICE201901
• Status: Not yet recruiting
• Start date: October 2019
• Est. completion date: July 2020

Study information

• Verified date: October 2019
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: Jian Zhao, dOCTOR
• Phone: 037158681065
• Email: doctorzhao66[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2020
• Est. primary completion date: May 2020
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Procedure:
• radiofrequency ablation
bipolar radiofrequency ablation by ablation forceps

Locations

Country	Name	City	State
China	Henan Provincial People' Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

References & Publications (9)

Briasoulis A, Sharma S, Telila T, Mallikethi-Reddy S, Papageorgiou N, Oikonomou E, Tousoulis D. MicroRNAs in Atrial Fibrillation. Curr Med Chem. 2019;26(5):855-863. doi: 10.2174/0929867324666170920151024. Review. — View Citation

Gal P, Marrouche NF. Magnetic resonance imaging of atrial fibrosis: redefining atrial fibrillation to a syndrome. Eur Heart J. 2017 Jan 1;38(1):14-19. doi: 10.1093/eurheartj/ehv514. Epub 2015 Sep 25. Review. — View Citation

Jia X, Zheng S, Xie X, Zhang Y, Wang W, Wang Z, Zhang Y, Wang J, Gao M, Hou Y. MicroRNA-1 accelerates the shortening of atrial effective refractory period by regulating KCNE1 and KCNB2 expression: an atrial tachypacing rabbit model. PLoS One. 2013 Dec 30;8(12):e85639. doi: 10.1371/journal.pone.0085639. eCollection 2013. — View Citation

Liu T, Zhong S, Rao F, Xue Y, Qi Z, Wu S. Catheter ablation restores decreased plasma miR-409-3p and miR-432 in atrial fibrillation patients. Europace. 2016 Jan;18(1):92-9. doi: 10.1093/europace/euu366. Epub 2015 Mar 16. — View Citation

McManus DD, Tanriverdi K, Lin H, Esa N, Kinno M, Mandapati D, Tam S, Okike ON, Ellinor PT, Keaney JF Jr, Donahue JK, Benjamin EJ, Freedman JE. Plasma microRNAs are associated with atrial fibrillation and change after catheter ablation (the miRhythm study). Heart Rhythm. 2015 Jan;12(1):3-10. doi: 10.1016/j.hrthm.2014.09.050. Epub 2014 Oct 9. — View Citation

Philpott JM, Zemlin CW, Cox JL, Stirling M, Mack M, Hooker RL, Morris A, Heimansohn DA, Longoria J, Gandhi DB, McCarthy PM. The ABLATE Trial: Safety and Efficacy of Cox Maze-IV Using a Bipolar Radiofrequency Ablation System. Ann Thorac Surg. 2015 Nov;100(5):1541-6; discussion 1547-8. doi: 10.1016/j.athoracsur.2015.07.006. Epub 2015 Sep 19. — View Citation

Sardu C, Santamaria M, Paolisso G, Marfella R. microRNA expression changes after atrial fibrillation catheter ablation. Pharmacogenomics. 2015 Nov;16(16):1863-77. doi: 10.2217/pgs.15.117. Epub 2015 Nov 10. Review. — View Citation

van den Berg NWE, Kawasaki M, Berger WR, Neefs J, Meulendijks E, Tijsen AJ, de Groot JR. MicroRNAs in Atrial Fibrillation: from Expression Signatures to Functional Implications. Cardiovasc Drugs Ther. 2017 Jun;31(3):345-365. doi: 10.1007/s10557-017-6736-z. Review. — View Citation

Wang M, Sun L, Ding W, Cai S, Zhao Q. Ablation alleviates atrial fibrillation by regulating the signaling pathways of endothelial nitric oxide synthase/nitric oxide via miR-155-5p and miR-24-3p. J Cell Biochem. 2019 Mar;120(3):4451-4462. doi: 10.1002/jcb.27733. Epub 2018 Oct 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	atrial fibrillation recurrence rate	Holter ECG record	six months after bipolar radiofrequency ablation
Primary	miRNA expression difference	miRNA-1, miRNA-19, miRNA-23, miRNA-29,miRNA-409,	six months after bipolar radiofrequency ablation