Atrial FibrillationNCT02175043
Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation
A study testing atrial electrogram and liner ablation 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 persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted catheter ablation. 2. Scientific evidence of the study 1. 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?
- atrial electrogram and liner ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jun 2014to 28 Feb 2017
- 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
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
About this study
- Purpose of the study
- To compare clinical outcome, procedure time, complication rate of persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted catheter 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 longstanding persistent atrial fibrillation.
- additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
- Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter 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 longstanding persistent atrial fibrillation
- compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. both strategies are conventional ablation strategies being performed world-wide.
- compare complex fractionated atrial electrogram before and after linear ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- atrial electrogram and liner ablation
- 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.
atrial electrogram and liner ablationProcedure or surgery
- The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
- The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| the operation to add in CFAE to conventional liner ablation | Experimental | The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients Receives: Procedure: atrial electrogram and liner ablation |
| only doing conventional liner ablation | Active comparator | The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation Receives: Procedure: atrial electrogram and liner ablation |
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 posted26 Jun 2014 (estimated)
- Study start3 Jun 2014
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175043
- Sponsor's protocol ID
- 4-2014-0282
- Status last verified
- Apr 2017
- First submitted
- 23 Jun 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02175043
- Acronym / sponsor ID
- 4-2014-0282
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 Jun 2014 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 26 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 persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted catheter 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 longstanding persistent atrial fibrillation.
- additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
- Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter 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 longstanding persistent atrial fibrillation
- compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. both strategies are conventional ablation strategies being performed world-wide.
- compare complex fractionated atrial electrogram before and after linear ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the operation to add in CFAE to conventional liner ablation | Experimental | Procedure: atrial electrogram and liner ablationThe group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients |
| only doing conventional liner ablation | Active comparator | Procedure: atrial electrogram and liner ablationThe group of negative is the operation to only doing conventional liner ablation with 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 |
|---|---|---|
| atrial electrogram and liner ablation1. The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients 2. The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation | Procedure or surgery | only doing conventional liner ablation, the operation to add in CFAE to conventional liner ablation |
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
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 25 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atrial electrogram and liner ablation 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: finished, as of the sponsor's last update on 25 Apr 2017. 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?
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?
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?
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 25 Apr 2017.