NCT04134793

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 18, 2019

Last Update Submit

October 18, 2019

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, ablation, microRNA

Outcome Measures

Primary Outcomes (2)

  • atrial fibrillation recurrence rate

    Holter ECG record

    six months after bipolar radiofrequency ablation

  • miRNA expression difference

    miRNA-1, miRNA-19, miRNA-23, miRNA-29,miRNA-409,

    six months after bipolar radiofrequency ablation

Study Arms (2)

Sinus group

Six-month follow-up, by holter ECG record，the patients keep normal sinus after atrial fibrillation radiofrequency ablation.

Procedure: radiofrequency ablation

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

Interventions

radiofrequency ablationPROCEDURE

bipolar radiofrequency ablation by ablation forceps

Sinus groupatrial fibrillation recurrence group

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • persistent atrial fibrillation, with alone mitral valve stenosis or regurgitation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Provincial People' Hospital

Zhengzhou, Henan, 450003, China

Location

Related Publications (9)

  • 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.

    PMID: 26554530BACKGROUND

  • 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.

    PMID: 26387721BACKGROUND

  • 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.

    PMID: 26409008BACKGROUND

  • 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.

    PMID: 28933293BACKGROUND

  • 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.

    PMID: 25257092BACKGROUND

  • 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.

    PMID: 28752208BACKGROUND

  • 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.

    PMID: 25782451BACKGROUND

  • 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.

    PMID: 30302809BACKGROUND

  • 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.

    PMID: 24386485BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

microRNA from left atrium appendage

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Xiaoqiang Quan, doctor

    Henan Provincial People' Hospital

    STUDY DIRECTOR

Central Study Contacts

Jian Zhao, dOCTOR

CONTACT

037158681065doctorzhao66@126.com

Leilei Zhang, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 22, 2019

Study Start

October 1, 2019

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)