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Atrial Fibrillation RecurrentNCT06202209

The Impact of Autonomic Function on Atrial Fibrillation Recurrence After Pulmonary Vein Ablation

An observational study of Atrial Fibrillation Recurrent, run by China National Center for Cardiovascular Diseases at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective and observational study. The investigator speculated that the use of DC in patients with paroxysmal AF can serve as a predictor for early and late AF recurrence following CPVI. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atrial Fibrillation Recurrent
What is being tested?
Circumferential Pulmonary Vein Isolation
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteChina
Study dates
13 Sep 2023to 30 Oct 2024
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing CPVI due to paroxysmal atrial fibrillation.

Who may be able to join

  • Sign the informed consent form;
  • Clearly diagnosed as paroxysmal AF, willing to receive CPVI treatment;
  • A class I or class III antiarrhythmic drug with poor efficacy, or intolerance to drugs.

Who cannot join

  • Diagnosis of sinus rhythm at recruitment;
  • Age is <18 years old or> 75 years old;
  • Transthoracic echocardiography suggested a left atrial anterior and posterior diameter of> 55mm;
  • Previous history of catheter ablation or surgical ablation for AF;
  • Left atrial thrombus recorded by ultrasound or CT;
  • With severe pulmonary diseases;
Show all 9Show fewer
  • Previous history of cardiac surgery;
  • Patients with hyperthyroidism, atrial septal defect, mitral valve stenosis or severe coronary heart disease who need further treatment;
  • During pregnancy or lactation.

Trial locations and contacts

1 site in 1 country.

yan Yao, PhD contact

13901121319

ianyao@263.net.cn

lihui Zheng, PhD contact

13910617612

zhenglihui@263.net

China1 site, 1 recruiting

  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing

    Zheng Lihui, MD PhD, +86-1391-0617-612, zhenglihui@263.net

    Recruiting

Other trials in China

About this study

Official title: The Impact of Autonomic Function on Recurrence Following Circumferential Pulmonary Vein Ablation for Atrial Fibrillation

This is a prospective and observational study. The investigator speculated that the use of DC in patients with paroxysmal AF can serve as a predictor for early and late AF recurrence following CPVI.

Read the detailed description

Atrial fibrillation (AF), also known as atrial flutter, is one of the most common cardiac arrhythmias and poses a serious threat to patients' health and well-being. The mechanism of AF is complex, with the autonomic nervous system playing a crucial role in its initiation and maintenance. Currently, medication and ablation are the main treatment methods to reduce AF episodes, but the efficacy of drug therapy is limited, and recurrence after ablation still exists. Recent studies have found that changes in autonomic nervous system activity are one of the key factors contributing to AF recurrence after ablation. Therefore, by objectively assessing changes in autonomic nervous system activity, it is expected to improve the success rate of AF ablation and provide a potential cure for AF, with significant social and economic value.

Studies have found that pulmonary vein isolation (PVI) ablation is the mainstream method for AF ablation, and it affects the autonomic nervous system function. Patients who show significant changes in autonomic nervous system function after AF ablation have higher success rates. Additionally, early-onset atrial arrhythmias are closely related to long-term AF recurrence after ablation. However, the mechanisms underlying early recurrence still require further investigation.

Our research team has conducted in-depth studies on the regulation of autonomic nervous system function in the heart and non-invasive assessment techniques, achieving breakthrough progress. The left atrial ganglion plays a crucial role in the initiation and maintenance of AF, and ablating the ganglion can improve the success rate of AF ablation. Non-invasive assessment techniques such as heart rate deceleration can quantitatively evaluate changes in vagal nerve activity in the heart, which can be used to predict the efficacy of autonomic ganglion intervention therapy.

Based on the above research, our research team hypothesizes that precise and quantitative assessment of autonomic nervous system function using heart rate deceleration can predict AF recurrence after PVI ablation. To validate this hypothesis, we plan to conduct a prospective observational study, recruiting patients with paroxysmal AF, assessing changes in autonomic nervous system function, monitoring early-onset atrial arrhythmias and AF recurrence, and providing theoretical support for the screening and intervention of high-risk recurrence patients, laying a foundation for clinical application.

Being tested
Circumferential Pulmonary Vein Isolation
Keywords
Atrial Fibrillation Recurrent, Early recurrent atrial arrhythmia, Cardioneuroablation, Automatic function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Circumferential Pulmonary Vein IsolationProcedure or surgery

    Circumferential pulmonary vein isolation (CPVI) is a type of cardiac ablation procedure. Cardiac ablation procedures involve creating small scars in the heart using thermal or cold energy to block irregular electrical signals and restore normal heart rhythm. CPVI specifically creates small scars in the area where the four pulmonary veins connect to the left atrium of the heart. The pulmonary veins carry oxygen-rich blood from the lungs to the heart.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of AF at 1 year after surgery

    Standard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring

    Measured: 12 months after CPVI

  2. Autonomic nerve function assessment

    The difference in DC values at 1 year compared to the preoperative baseline

    Measured: 12 months after CPVI

Secondary outcomes (4)

  1. Recurrence of AF at 1 month after surgery

    Standard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring

    Measured: 1 months after CPVI

  2. Autonomic nerve function assessment

    The difference in DC values at 1 month compared to the preoperative baseline

    Measured: 1 months after CPVI

  3. Recurrence of AF at 3 months after surgery

    Standard 12-lead surface electrocardiogram (ECG) and 24-hour ECG monitoring

    Measured: 3 months after CPVI

  4. Autonomic nerve function assessment

    The difference in DC values at 3 months compared to the preoperative baseline

    Measured: 3 months after CPVI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start13 Sep 2023
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Oct 2024 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06202209
Sponsor's protocol ID
2022-RW320-11
Status last verified
Nov 2023
First submitted
2 Jan 2024
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

    PubMed 32860505

  • Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and Clinical Outcomes. Circ Res. 2017 Apr 28;120(9):1501-1517. doi: 10.1161/CIRCRESAHA.117.309732.

    PubMed 28450367

  • Chen Z, Yang Y, Zou C, Zhang Y, Huang X, Li X, Yang X. Low heart deceleration capacity imply higher atrial fibrillation-free rate after ablation. Sci Rep. 2018 Apr 3;8(1):5537. doi: 10.1038/s41598-018-23970-7.

    PubMed 29615802

  • Sordillo LM, Redmond MJ, Campos M, Warren L, Babiuk LA. Cytokine activity in bovine mammary gland secretions during the periparturient period. Can J Vet Res. 1991 Jul;55(3):298-301.

    PubMed 1716178

  • Herring N, Kalla M, Paterson DJ. The autonomic nervous system and cardiac arrhythmias: current concepts and emerging therapies. Nat Rev Cardiol. 2019 Dec;16(12):707-726. doi: 10.1038/s41569-019-0221-2. Epub 2019 Jun 13.

    PubMed 31197232

  • Shen MJ, Choi EK, Tan AY, Lin SF, Fishbein MC, Chen LS, Chen PS. Neural mechanisms of atrial arrhythmias. Nat Rev Cardiol. 2011 Sep 27;9(1):30-9. doi: 10.1038/nrcardio.2011.139.

    PubMed 21946776

  • Shen MJ, Zipes DP. Role of the autonomic nervous system in modulating cardiac arrhythmias. Circ Res. 2014 Mar 14;114(6):1004-21. doi: 10.1161/CIRCRESAHA.113.302549.

    PubMed 24625726

  • January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Jul 9;74(1):104-132. doi: 10.1016/j.jacc.2019.01.011. Epub 2019 Jan 28. No abstract available.

    PubMed 30703431

  • Ketels S, Houben R, Van Beeumen K, Tavernier R, Duytschaever M. Incidence, timing, and characteristics of acute changes in heart rate during ongoing circumferential pulmonary vein isolation. Europace. 2008 Dec;10(12):1406-14. doi: 10.1093/europace/eun287. Epub 2008 Oct 19.

    PubMed 18936041

  • Tang LYW, Hawkins NM, Ho K, Tam R, Deyell MW, Macle L, Verma A, Khairy P, Sheldon R, Andrade JG; CIRCA-DOSE Study Investigators. Autonomic Alterations After Pulmonary Vein Isolation in the CIRCA-DOSE (Cryoballoon vs Irrigated Radiofrequency Catheter Ablation) Study. J Am Heart Assoc. 2021 Feb;10(5):e018610. doi: 10.1161/JAHA.120.018610. Epub 2021 Feb 26.

    PubMed 33634706

  • Yang E, Ipek EG, Balouch M, Mints Y, Chrispin J, Marine JE, Berger RD, Ashikaga H, Rickard J, Calkins H, Nazarian S, Spragg DD. Factors impacting complication rates for catheter ablation of atrial fibrillation from 2003 to 2015. Europace. 2017 Feb 1;19(2):241-249. doi: 10.1093/europace/euw178.

    PubMed 28172794

  • Yao Y, Zheng L, Zhang S, He DS, Zhang K, Tang M, Chen K, Pu J, Wang F, Chen X. Stepwise linear approach to catheter ablation of atrial fibrillation. Heart Rhythm. 2007 Dec;4(12):1497-504. doi: 10.1016/j.hrthm.2007.07.028. Epub 2007 Aug 11.

    PubMed 17997359

  • Liang JJ, Elafros MA, Chik WW, Santangeli P, Zado ES, Frankel DS, Supple GE, Schaller RD, Lin D, Hutchinson MD, Riley MP, Callans DJ, Marchlinski FE, Dixit S. Early recurrence of atrial arrhythmias following pulmonary vein antral isolation: Timing and frequency of early recurrences predicts long-term ablation success. Heart Rhythm. 2015 Dec;12(12):2461-8. doi: 10.1016/j.hrthm.2015.07.015. Epub 2015 Jul 14.

    PubMed 26187447

  • Oral H, Knight BP, Ozaydin M, Tada H, Chugh A, Hassan S, Scharf C, Lai SW, Greenstein R, Pelosi F Jr, Strickberger SA, Morady F. Clinical significance of early recurrences of atrial fibrillation after pulmonary vein isolation. J Am Coll Cardiol. 2002 Jul 3;40(1):100-4. doi: 10.1016/s0735-1097(02)01939-3.

    PubMed 12103262

  • Nalliah CJ, Lim TW, Kizana E, Qian P, Kovoor P, Thiagalingam A, Ross DL, Thomas SP. Clinical significance of early atrial arrhythmia type and timing after single ring isolation of the pulmonary veins. Europace. 2015 Jul;17(7):1038-44. doi: 10.1093/europace/euu314. Epub 2015 May 2.

    PubMed 25935165

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation Recurrent, run by China National Center for Cardiovascular Diseases 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 3 inclusion and 9 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 11 Jan 2024. 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 yan Yao, PhD (13901121319, ianyao@263.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of AF at 1 year after surgery (time frame: 12 months after CPVI). 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 NCT06202209, which also lists 24 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 11 Jan 2024.

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