Atrial FibrillationNCT04134793
Correlation of Atrial Fibrillation Recurrence After Bipolar Radiofrequency Ablation With microRNA Expression
An observational study of Atrial Fibrillation, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2019to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- persistent atrial fibrillation, with alone mitral valve stenosis or regurgitation
Who cannot join
- left atrium more than 60mm ejection fraction less than 30% complicated with other valve disease of aortic valve stenosis or regurgitation
Trial locations and contacts
1 site in 1 country.
Leilei Zhang, doctor contact
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- radiofrequency ablation
- Keywords
- atrial fibrillation, ablation, microRNA
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
bipolar radiofrequency ablation by ablation forceps
| Study group | Role | What they receive |
|---|---|---|
| Sinus group | Six-month follow-up, by holter ECG record，the patients keep normal sinus after atrial fibrillation radiofrequency ablation. Receives: 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. Receives: Procedure: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation recurrence rate
Holter ECG record
Measured: six months after bipolar radiofrequency ablation
miRNA expression difference
miRNA-1, miRNA-19, miRNA-23, miRNA-29,miRNA-409,
Measured: six months after bipolar radiofrequency ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study startOct 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhao, Henan Institute of Cardiovascular Epidemiology
- Investigators
- Xiaoqiang Quan, doctor, Study director, Henan Provincial People' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134793
- Sponsor's protocol ID
- HenanICE201901
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26554530Philpott 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.
PubMed 26387721Gal 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.
PubMed 26409008Briasoulis 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.
PubMed 28933293McManus 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.
PubMed 25257092van 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.
PubMed 28752208Liu 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.
PubMed 25782451Wang 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.
PubMed 30302809Jia 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.
PubMed 24386485
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Atrial Fibrillation Recurrence After Bipolar Radiofrequency Ablation With microRNA Expression
- ClinicalTrials.gov ID
- NCT04134793
- Acronym / sponsor ID
- HenanICE201901
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, ablation, microRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinus group | – | Procedure: radiofrequency ablationSix-month follow-up, by holter ECG record，the patients keep normal sinus after atrial fibrillation radiofrequency ablation. |
| atrial fibrillation recurrence group | – | Procedure: radiofrequency ablationSix-month follow-up, by holter ECG record，the patients again suffer from atrial fibrillation after atrial fibrillation radiofrequency ablation. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- persistent atrial fibrillation, with alone mitral valve stenosis or regurgitation
Key exclusion criteria (1 listed)
- left atrium more than 60mm ejection fraction less than 30% complicated with other valve disease of aortic valve stenosis or regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency ablationbipolar radiofrequency ablation by ablation forceps | Procedure or surgery | Sinus group, atrial fibrillation recurrence group |
Primary outcome
atrial fibrillation recurrence rate
Time frame: six months after bipolar radiofrequency ablation
Holter ECG record
miRNA expression difference
Time frame: six months after bipolar radiofrequency ablation
miRNA-1, miRNA-19, miRNA-23, miRNA-29,miRNA-409,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Background: PubMed 26554530Sardu 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.
- Background: PubMed 26387721Philpott 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.
- Background: PubMed 26409008Gal 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.
- Background: PubMed 28933293Briasoulis 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.
- Background: PubMed 25257092McManus 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.
- Background: PubMed 28752208van 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.
- Background: PubMed 25782451Liu 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.
- Background: PubMed 30302809Wang 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.
- Background: PubMed 24386485Jia 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.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leilei Zhang, doctor contact
Xiaoqiang Quan, doctor study director
Henan Provincial People' Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhao, dOCTOR (037158681065, doctorzhao66@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial fibrillation recurrence rate (time frame: six months after bipolar radiofrequency ablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04134793, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.