Atrial FibrillationNCT02176616
Evaluation of Proper Radiofrequency Catheter Ablation Strategy for the Patients Who Were Changed to Paroxysmal Atrial Fibrillation From Persistent Atrial Fibrillation
A study testing linear ablation and pulmonary vein isolation in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
1. Purpose of the study 1) To compare clinical outcome, procedure time, complication rate of patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary vein isolation with… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- linear ablation and pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Jun 2024
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) 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.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Hui-Nam Pak, MD, 82-2-2228-8459, hnpak@yuhs.ac
About this study
- Purpose of the study
- To compare clinical outcome, procedure time, complication rate of patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary vein isolation with conventional linear ablation.
- Scientific evidence of the study
- In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
- drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
- catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
- However, there are no consensus for proper ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation .
- additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
- Therefore, we will compare conventional pulmonary vein isolation with additional conventional linear ablation.
- Methods
- Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation.
- there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.
- study contents
- to evaluate superior ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
- compare conventional pulmonary vein isolation with additional liner ablation, both strategies are conventional ablation strategies being performed world-wide.
- Conditions
- Atrial Fibrillation
- Being tested
- linear ablation, pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linear ablationProcedure or surgery
The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
pulmonary vein isolationProcedure or surgery
The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| linear ablation | Active comparator | The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation Receives: Procedure: linear ablation |
| pulmonary vein isolation | Experimental | The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation Receives: Procedure: pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation
lifelong, checked per every outpatient clinic visit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176616
- Sponsor's protocol ID
- 4-2014-0279
- Status last verified
- Mar 2019
- First submitted
- 23 Jun 2014
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pak HN, Park J, Park JW, Yang SY, Yu HT, Kim TH, Uhm JS, Choi JI, Joung B, Lee MH, Kim YH, Shim J. Electrical Posterior Box Isolation in Persistent Atrial Fibrillation Changed to Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Randomized Study. Circ Arrhythm Electrophysiol. 2020 Sep;13(9):e008531. doi: 10.1161/CIRCEP.120.008531. Epub 2020 Jul 28.
PubMed 32755396Yu HT, Shim J, Park J, Kim IS, Kim TH, Uhm JS, Joung B, Lee MH, Kim YH, Pak HN. Pulmonary Vein Isolation Alone Versus Additional Linear Ablation in Patients With Persistent Atrial Fibrillation Converted to Paroxysmal Type With Antiarrhythmic Drug Therapy: A Multicenter, Prospective, Randomized Study. Circ Arrhythm Electrophysiol. 2017 Jun;10(6):e004915. doi: 10.1161/CIRCEP.116.004915.
PubMed 28611206
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Proper Radiofrequency Catheter Ablation Strategy for the Patients Who Were Changed to Paroxysmal Atrial Fibrillation From Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02176616
- Acronym / sponsor ID
- 4-2014-0279
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 Jun 2014 (estimated)
- 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.
- Purpose of the study
- To compare clinical outcome, procedure time, complication rate of patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary vein isolation with conventional linear ablation.
- Scientific evidence of the study
- In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
- drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
- catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
- However, there are no consensus for proper ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation .
- additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
- Therefore, we will compare conventional pulmonary vein isolation with additional conventional linear ablation.
- Methods
- Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation.
- there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.
- study contents
- to evaluate superior ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
- compare conventional pulmonary vein isolation with additional liner ablation, both strategies are conventional ablation strategies being performed world-wide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| linear ablation | Active comparator | Procedure: linear ablationThe group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation |
| pulmonary vein isolation | Experimental | Procedure: pulmonary vein isolationThe group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| linear ablationThe group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation | Procedure or surgery | linear ablation |
| pulmonary vein isolationThe group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation | Procedure or surgery | pulmonary vein isolation |
Primary outcome
number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation
Time frame: 1 year
lifelong, checked per every outpatient clinic visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Derived from this study: PubMed 32755396Pak HN, Park J, Park JW, Yang SY, Yu HT, Kim TH, Uhm JS, Choi JI, Joung B, Lee MH, Kim YH, Shim J. Electrical Posterior Box Isolation in Persistent Atrial Fibrillation Changed to Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Randomized Study. Circ Arrhythm Electrophysiol. 2020 Sep;13(9):e008531. doi: 10.1161/CIRCEP.120.008531. Epub 2020 Jul 28.
- Derived from this study: PubMed 28611206Yu HT, Shim J, Park J, Kim IS, Kim TH, Uhm JS, Joung B, Lee MH, Kim YH, Pak HN. Pulmonary Vein Isolation Alone Versus Additional Linear Ablation in Patients With Persistent Atrial Fibrillation Converted to Paroxysmal Type With Antiarrhythmic Drug Therapy: A Multicenter, Prospective, Randomized Study. Circ Arrhythm Electrophysiol. 2017 Jun;10(6):e004915. doi: 10.1161/CIRCEP.116.004915.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing linear ablation and pulmonary vein isolation in people with 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: status not confirmed, as of the sponsor's last update on 28 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?
Results are not available in the source record.
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?
number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation (time frame: 1 year). 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 NCT02176616, which also lists 2 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 28 Mar 2019.