Persistent Atrial FibrillationNCT01088126
Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms in Persistent Atrial Fibrillation
A study testing radiofrequency catheter ablation in people with Persistent Atrial Fibrillation, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial tachyarrhythmias (AT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- radiofrequency catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to 2 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients age 18 or greater
- persistent atrial fibrillation
- candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication
- at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial
- continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation
- patients must be able and willing to provide written informed consent to participate in the clinical trial
Who cannot join
- paroxysmal or permanent atrial fibrillation
- patients with AF felt to be secondary to an obvious reversible cause
- inadequate anticoagulation as defined in the inclusion criteria
- left atrial thrombus on TEE prior to procedure
- contraindications to systemic anticoagulation with heparin or coumadin
- previously undergone atrial fibrillation ablation
- patients who are or may potentially be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms After Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: A Prospective & Randomized Controlled Study
The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- radiofrequency catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency catheter ablationProcedure or surgery
radiofrequency catheter ablation, NavX system
| Study group | Role | What they receive |
|---|---|---|
| Focal ablation | Active comparator | PV isolation + CFAE-targeted focal ablation Receives: Procedure: radiofrequency catheter ablation |
| Linear ablation | Active comparator | PV isolation + CFAE-guided linear ablation Receives: Procedure: radiofrequency catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom from AF/AT more than 3 months after first ablation
Measured: 12 months
Secondary outcomes (6)
freedom from AF/AT within 3 months following first ablation
Measured: 3 months
acute intra-procedure termination of AF
Measured: 12 months
organization of AF/conversion to AT during the ablation
Measured: 12 months
procedure time
Measured: 12 months
ablation time
Measured: 12 months
procedure-related complication
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completion2 Mar 2017
Why it stopped: It was difficult to enrol patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Young-Hoon Kim, M.D., Ph.D., Principal investigator, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088126
- Sponsor's protocol ID
- AN09239
- Status last verified
- Jan 2010
- First submitted
- 1 Mar 2010
- Last updated
- 20 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms After Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: A Prospective & Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01088126
- Acronym / sponsor ID
- AN09239
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was difficult to enrol patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 17 Mar 2010 (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.
The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focal ablation | Active comparator | Procedure: radiofrequency catheter ablationPV isolation + CFAE-targeted focal ablation |
| Linear ablation | Active comparator | Procedure: radiofrequency catheter ablationPV isolation + CFAE-guided linear ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients age 18 or greater
- persistent atrial fibrillation
- candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication
- at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial
- continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation
Key exclusion criteria (7 listed)
- paroxysmal or permanent atrial fibrillation
- patients with AF felt to be secondary to an obvious reversible cause
- inadequate anticoagulation as defined in the inclusion criteria
- left atrial thrombus on TEE prior to procedure
- contraindications to systemic anticoagulation with heparin or coumadin
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 |
|---|---|---|
| radiofrequency catheter ablationradiofrequency catheter ablation, NavX system | Procedure or surgery | Focal ablation, Linear ablation |
Primary outcome
freedom from AF/AT more than 3 months after first ablation
Time frame: 12 months
6 secondary outcomes
freedom from AF/AT within 3 months following first ablation
Time frame: 3 months
acute intra-procedure termination of AF
Time frame: 12 months
organization of AF/conversion to AT during the ablation
Time frame: 12 months
procedure time
Time frame: 12 months
ablation time
Time frame: 12 months
procedure-related complication
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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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.
Young-Hoon Kim, M.D., Ph.D. principal investigator
Korea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency catheter ablation in people with Persistent Atrial Fibrillation, run by Korea University Anam Hospital 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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 20 Mar 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
freedom from AF/AT more than 3 months after first ablation (time frame: 12 months). 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 20 Mar 2018.