AzTrials
AzTrials

Atrial FibrillationNCT02138695

The Evaluation for Prognostic Factors After Catheter Ablation of Atrial Fibrillation: Cohort Study

An observational study of Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

1. Purpose of the study 1) To explore clinical recurrence associated clinical factors including age, sex, clinical, electrophysiological, anatomical, imaging, and serologic characteristics. 2) To develop simulation model to predict clinical recurrence and the efficacy of catheter ablation 2. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Atrial Fibrillation
How many people
3,100 participants
Where
1 siteSouth Korea
Study dates
May 2014to Feb 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients with atrial fibrillation who undergoing catheter ablation in Yonsei Cardiovascular hospital, Yonsei university health system, Seoul, Korea.

Who may be able to join

  • patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

Who cannot join

  • patients who do not agree with study inclusion
  • permanent AF refractory to electrical cardioversion
  • AF with valvular disease ≥ grade 2
  • patients with left atrial diameter greater than 60mm
  • patients with age less than 19

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hui-Nam Pak, MD contact

82-2-2228-8459

hnpak@yuhs.ac

South Korea1 site, 1 recruiting

  • Severance Hospital

    Seoul, 120-752

    Hui-Nam Pak, 82-2-2228-8459, hnpak@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

  1. Purpose of the study
  2. To explore clinical recurrence associated clinical factors including age, sex, clinical, electrophysiological, anatomical, imaging, and serologic characteristics.
  3. To develop simulation model to predict clinical recurrence and the efficacy of catheter ablation 2. Scientific evidence of the study
  4. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
  5. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
  6. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
  7. clinical outcome after catheter ablation is affected not only by age, sex and underlying disease, but also by electrophysiologic, imaging, serologic and electroanatomical remodeling of the heart. However, there are few studies concerning these multifactorial variables.
  8. Study population
Keywords
atrial fibrillation, catheter ablation, recurrence
Medical subject headings
Atrial Fibrillation, Recurrence

What participants receive

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

Study groups in NCT02138695
Study groupRoleWhat they receive
Yonsei AF CohortPatients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation

What is being measured

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

  1. Clinical recurrence of atrial fibrillation (AF) after catheter ablation

    We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Patients were asked to attend scheduled outpatient follow-up appointments 2, 6, 12, 18, 24, 36, 48 and 60 months after catheter ablation.

    Measured: Participants will be followed for 5 year after catheter ablation

Timeline

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

  1. First posted14 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (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
3,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02138695
Sponsor's protocol ID
4-2014-0104
Status last verified
Mar 2019
First submitted
16 Apr 2014
Last updated
18 Mar 2019
Results posted
No

Publications

  • Cho S, Kim D, Park H, Kwon OS, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. Mapping and ablation outcomes of extra-pulmonary vein triggers in atrial fibrillation: single-centre retrospective study with consistent provocation protocol. Europace. 2025 Oct 7;27(10):euaf225. doi: 10.1093/europace/euaf225.

    PubMed 40974035

  • Hwang T, Lim B, Kwon OS, Kim MH, Kim D, Park JW, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Hwang C, Pak HN. Clinical usefulness of digital twin guided virtual amiodarone test in patients with atrial fibrillation ablation. NPJ Digit Med. 2024 Oct 23;7(1):297. doi: 10.1038/s41746-024-01298-z.

    PubMed 39443659

  • Park JS, Cho I, Kim D, Kim MH, Park JW, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. Differentiating Left Atrial Pressure Responses in Paroxysmal and Persistent Atrial Fibrillation: Implications for Diagnosing Heart Failure With Preserved Ejection Fraction and Managing Atrial Fibrillation. J Am Heart Assoc. 2024 Sep 3;13(17):e035246. doi: 10.1161/JAHA.124.035246. Epub 2024 Aug 27.

    PubMed 39189473

  • Jin Z, Hwang T, Kim D, Lim B, Kwon OS, Kim S, Kim MH, Park JW, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. Anti- and pro-fibrillatory effects of pulmonary vein isolation gaps in human atrial fibrillation digital twins. NPJ Digit Med. 2024 Mar 26;7(1):81. doi: 10.1038/s41746-024-01075-y.

    PubMed 38532181

  • Park YJ, Park JW, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. Sex difference in atrial fibrillation recurrence after catheter ablation and antiarrhythmic drugs. Heart. 2023 Mar 10;109(7):519-526. doi: 10.1136/heartjnl-2021-320601.

    PubMed 35332048

  • Kim M, Yu HT, Kim TH, Lee DI, Uhm JS, Kim YD, Nam HS, Joung B, Lee MH, Heo JH, Pak HN. Ischemic Stroke in Non-Gender-Related CHA2DS2-VA Score 0~1 Is Associated With H2FPEF Score Among the Patients With Atrial Fibrillation. Front Cardiovasc Med. 2022 Feb 8;8:791112. doi: 10.3389/fcvm.2021.791112. eCollection 2021.

    PubMed 35211517

  • Kwon OS, Hong M, Kim TH, Hwang I, Shim J, Choi EK, Lim HE, Yu HT, Uhm JS, Joung B, Oh S, Lee MH, Kim YH, Pak HN. Genome-wide association study-based prediction of atrial fibrillation using artificial intelligence. Open Heart. 2022 Jan;9(1):e001898. doi: 10.1136/openhrt-2021-001898.

    PubMed 35086918

  • Kim M, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. One-Year Change in the H2FPEF Score After Catheter Ablation of Atrial Fibrillation in Patients With a Normal Left Ventricular Systolic Function. Front Cardiovasc Med. 2021 Aug 3;8:699364. doi: 10.3389/fcvm.2021.699364. eCollection 2021.

    PubMed 34414218

  • Pak HN, Park JW, Yang SY, Kim M, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH. Sex differences in mapping and rhythm outcomes of a repeat atrial fibrillation ablation. Heart. 2021 Dec;107(23):1862-1867. doi: 10.1136/heartjnl-2020-318282. Epub 2021 Jan 22.

    PubMed 33483352

  • Park JW, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Hwang C, Pak HN. Atrial Fibrillation Catheter Ablation Increases the Left Atrial Pressure. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e007073. doi: 10.1161/CIRCEP.118.007073.

    PubMed 30917688

  • Kim TH, Lee JS, Park J, Park JK, Uhm JS, Joung B, Lee MH, Pak HN. Blunted rate-dependent left atrial pressure response during isoproterenol infusion in atrial fibrillation patients with impaired left ventricular diastolic function: a comparison to pacing. Europace. 2015 Oct;17 Suppl 2:ii89-96. doi: 10.1093/europace/euv239.

    PubMed 26842122

  • Choi EK, Park JH, Lee JY, Nam CM, Hwang MK, Uhm JS, Joung B, Ko YG, Lee MH, Lubitz SA, Ellinor PT, Pak HN. Korean Atrial Fibrillation (AF) Network: Genetic Variants for AF Do Not Predict Ablation Success. J Am Heart Assoc. 2015 Aug 13;4(8):e002046. doi: 10.1161/JAHA.115.002046.

    PubMed 26272656

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.

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 5 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: looking for participants now, as of the sponsor's last update on 18 Mar 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 South Korea. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hui-Nam Pak, MD (82-2-2228-8459, hnpak@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical recurrence of atrial fibrillation (AF) after catheter ablation (time frame: Participants will be followed for 5 year after catheter ablation). 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 NCT02138695, which also lists 12 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 18 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in