Atrial FibrillationNCT03479073
Risk Factors of Stroke or Systemic Embolism After Atrial Fibrillation Ablation
An observational study of Atrial Fibrillation, run by Korea University Guro Hospital at 3 sites in South Korea.
Trial summary
To investigate the rate and risk factors of stroke or systemic embolism (SE) following atrial fibrillation (AF) ablation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 3,198 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 17 May 2017to 14 Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population was extracted from a consortium of registry of AF ablation by three University Hospitals (Korea univ Guro, Korea univ Anam and Seoul National University) from 1998 to 2016.
Who may be able to join
- Patients who underwent catheter ablation for AF
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: The Characteristics of Patients Experiencing Stroke or Systemic Embolism During Follow up Period After Atrial Fibrillation Ablation
To investigate the rate and risk factors of stroke or systemic embolism (SE) following atrial fibrillation (AF) ablation.
Read the detailed description
Since catheter ablation for AF reduces the burden of AF effectively, several studies have demonstrated that catheter ablation not only improves the quality of life but also reduces the risk of stroke and all cause mortality. However, until now the guideline has recommended the continuation of oral anticoagulation (OAC) therapy in patients who are at risk of stroke or systemic embolism (SE) based on the CHA2DS2-VASc score, even though they have sinus rhythm following catheter ablation. The aims of this retrospective study is to assess the rate of stroke/SE during follow-up period after AF ablation and identify the independent risk factors for stroke/SE in patients who underwent catheter ablation for AF.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke group | Patients who experienced stroke or systemic embolic event following catheter ablation for AF. | |
| Control group | Patients who did not experienced stroke or systemic embolic event following catheter ablation for AF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of stroke or systemic embolism after AF ablation
Risk factors for stroke or systemic embolism after AF ablation
Measured: From the time of catheter ablation until the date of the last visit or the date of event.(Retrospective period of up to 20 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start17 May 2017
- Primary completion14 Jun 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanmi Pharmaceutical Company Limited
- Responsible party
- Principal investigator, Hong Euy Lim, MD, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479073
- Sponsor's protocol ID
- KUGH17098-001
- Status last verified
- Jun 2018
- First submitted
- 6 Mar 2018
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahn J, Shin SY, Shim J, Kim YH, Han SJ, Choi EK, Oh S, Shin JY, Choe JC, Park JS, Lee HW, Oh JH, Choi JH, Lee HC, Cha KS, Hong TJ, Lip GYH, Lim HE. Association between epicardial adipose tissue and embolic stroke after catheter ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2019 Nov;30(11):2209-2216. doi: 10.1111/jce.14154. Epub 2019 Sep 19.
PubMed 31502330
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Patients Experiencing Stroke or Systemic Embolism During Follow up Period After Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT03479073
- Acronym / sponsor ID
- KUGH17098-001
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,198 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Hanmi Pharmaceutical Company Limited
- Study start
- 17 May 2017 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 27 Mar 2018 (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.
To investigate the rate and risk factors of stroke or systemic embolism (SE) following atrial fibrillation (AF) ablation.
Detailed description
Since catheter ablation for AF reduces the burden of AF effectively, several studies have demonstrated that catheter ablation not only improves the quality of life but also reduces the risk of stroke and all cause mortality. However, until now the guideline has recommended the continuation of oral anticoagulation (OAC) therapy in patients who are at risk of stroke or systemic embolism (SE) based on the CHA2DS2-VASc score, even though they have sinus rhythm following catheter ablation. The aims of this retrospective study is to assess the rate of stroke/SE during follow-up period after AF ablation and identify the independent risk factors for stroke/SE in patients who underwent catheter ablation for AF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke group | – | –Patients who experienced stroke or systemic embolic event following catheter ablation for AF. |
| Control group | – | –Patients who did not experienced stroke or systemic embolic event following catheter ablation for AF. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population was extracted from a consortium of registry of AF ablation by three University Hospitals (Korea univ Guro, Korea univ Anam and Seoul National University) from 1998 to 2016.
Key inclusion criteria (1 listed)
- Patients who underwent catheter ablation for AF
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of stroke or systemic embolism after AF ablation
Time frame: From the time of catheter ablation until the date of the last visit or the date of event.(Retrospective period of up to 20 years)
Risk factors for stroke or systemic embolism after AF ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Derived from this study: PubMed 31502330Ahn J, Shin SY, Shim J, Kim YH, Han SJ, Choi EK, Oh S, Shin JY, Choe JC, Park JS, Lee HW, Oh JH, Choi JH, Lee HC, Cha KS, Hong TJ, Lip GYH, Lim HE. Association between epicardial adipose tissue and embolic stroke after catheter ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2019 Nov;30(11):2209-2216. doi: 10.1111/jce.14154. Epub 2019 Sep 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 Korea University Guro Hospital at 3 sites 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 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: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stroke or systemic embolism after AF ablation (time frame: From the time of catheter ablation until the date of the last visit or the date of event.(Retrospective period of up to 20 years)). 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 NCT03479073, which also lists 1 linked publication.
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 Jun 2018.