Atrial FibrillationNCT04632550
Giant Left Atrium Atrial fibrillatioN CathEter Ablation, Posterior Box Isolation vs. Dallas Lesion Set
A study testing Circumferential pulmonary vein isolation(CPVI) group, Posterior box isolation(POBI) group and POBI+Anterior linear ablation(AL) group in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
Although the additional linear ablation after pulmonary vein isolation (PVI) is a class IIB indication for AF catheter ablation in patients with persistent AF, no clear benefit has been demonstrated in the recent randomized clinical trials (STAR-AF2 or POBI trials). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Circumferential pulmonary vein isolation(CPVI) group, Posterior box isolation(POBI) group and POBI+Anterior linear ablation(AL) group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2020to Oct 2025
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with persistent atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
- Left atrium size ≥ 50mm
- Persistent atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
- Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)
Who cannot join
- AF Patients with LA size less than 50mm
- Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
- Patients with severe renal impairment or CT imaging difficulty using contrast media
- Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
- Patients with active internal bleeding
- Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
Show all 12Show fewer
- Patients with valvular atrial fibrillation (mitral stenosis >grade 2, mechanical valve, mitral valvuloplasty)
- Patients with a severe comorbid disease
- Expected survival < 1 year
- Drug addicts or alcoholics
- Patients who cannot read the consent form (illiterates, foreigners, etc.)
- Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei Severance Hospital
Seoul
Hui-Nam Pak, 82-2-2228-8459, hnpak@yuhs.ac
About this study
Official title: Giant Left Atrium Atrial fibrillatioN CathEter Ablation, Posterior Box Isolation vs. Dallas Lesion Set: Prospective Randomized Trial (GLANCE Trial)
Although the additional linear ablation after pulmonary vein isolation (PVI) is a class IIB indication for AF catheter ablation in patients with persistent AF, no clear benefit has been demonstrated in the recent randomized clinical trials (STAR-AF2 or POBI trials). Nevertheless, in the retrospective cohort data of this research team, additional POBI and AL were helpful in persistent AF patients with left atrial (LA) size > 50mm or more or low LA voltage. The purpose of this study was to evaluate the efficacy and safety of additional POBI and AL compared to CPVI alone in persistent AF patients with LA size over 50mm. Also, we intend to proceed with this randomized clinical trial with the high power short duration ablation protocol, which is effective in shortening the procedure time.
Read the detailed description
- Study design
- Prospective randomization (pulmonary vein isolation [PVI] group vs. additional posterior box isolation [POBI] group vs. additional POBI and anterior line [AL] group)
- Target number of subjects: 480 (160 per group)
- Rhythm follow-up : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.
- Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Follow-up at 1 weeks, 3 months, and thereafter every 6-month after procedure.
- Rhythm control at 3 months, and thereafter every 6-month follow-up with Holter
- If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.
- Follow-up All the patients will be followed-up at 1, 3, 6 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.
- Conditions
- Atrial Fibrillation
- Being tested
- Circumferential pulmonary vein isolation(CPVI) group, Posterior box isolation(POBI) group, POBI+Anterior linear ablation(AL) group
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumferential pulmonary vein isolation(CPVI) groupProcedure or surgery
- PVI(pulmonary vein isolation) will be performed using a radiofrequency catheter
- Esophageal temperature will be monitored to prevent esophageal injury.
- Evaluation of procedure time, radiofrequency ablation time
- Evaluation of the complication after the procedure.
- Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
Posterior box isolation(POBI) groupProcedure or surgery
- PVI will be performed using a radiofrequency catheter
- Additional POBI(Posterior box isolation) is performed according to the traditional method and experience of the practitioner.
- Esophageal temperature will be monitored to prevent esophageal injury.
- The bidirectional block of each lesion set is the target of the procedures. But, we remain the incomplete block if three times of linear ablation failed to achieve the bidirectional block for the safety purpose.
- Evaluation of procedure time, radiofrequency ablation time
- Evaluation of the complication after the procedure.
- Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
POBI+Anterior linear ablation(AL) groupProcedure or surgery
- PVI, POBI will be performed using a radiofrequency catheter
- Additional AL(anterior linear) ablation is performed according to the traditional method and experience of the practitioner.
- Esophageal temperature will be monitored to prevent esophageal injury.
- The bidirectional block of each lesion set is the target of the procedures. But, we remain the incomplete block if three times of linear ablation failed to achieve the bidirectional block for the safety purpose.
- Evaluation of procedure time, radiofrequency ablation time
- Evaluation of the complication after the procedure.
- Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
| Study group | Role | What they receive |
|---|---|---|
| Circumferential pulmonary vein isolation(CPVI) group | Active comparator | Not described Receives: Procedure: Circumferential pulmonary vein isolation(CPVI) group |
| Posterior box isolation(POBI) group | Experimental | Not described Receives: Procedure: Posterior box isolation(POBI) group |
| POBI+Anterior linear ablation(AL) group | Experimental | Not described Receives: Procedure: POBI+Anterior linear ablation(AL) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation: Procedure-related cardiac complication rate
-including open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications within 30 days post procedure.
Measured: within 30 days post procedure
Efficacy evaluation: clinical recurrence rate
- Defined as atrial fibrillation or atrial tachycardia > 30 sec after 3 months within 1 year; based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Measured: Within 1 year after 3 months of procedure
Efficacy evaluation: Major cardiovascular event rate
- death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Measured: immediate after procedure
Efficacy evaluation: Major cardiovascular event rate
- death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Measured: 12 months after procedure
Secondary outcomes (5)
procedure time
Measured: immediate after the procedure
hospitalization duration
Measured: immediate after the discharge
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Measured: immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure.
rate of electrical cardioversion
Measured: immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure.
rate of cardiovascular hospitalization
Measured: immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study startDec 2020 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
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
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Nam Pak, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632550
- Sponsor's protocol ID
- 4-2020-0954
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giant Left Atrium Atrial fibrillatioN CathEter Ablation, Posterior Box Isolation vs. Dallas Lesion Set: Prospective Randomized Trial (GLANCE Trial)
- ClinicalTrials.gov ID
- NCT04632550
- Acronym / sponsor ID
- 4-2020-0954
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 17 Nov 2020 (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.
Although the additional linear ablation after pulmonary vein isolation (PVI) is a class IIB indication for AF catheter ablation in patients with persistent AF, no clear benefit has been demonstrated in the recent randomized clinical trials (STAR-AF2 or POBI trials). Nevertheless, in the retrospective cohort data of this research team, additional POBI and AL were helpful in persistent AF patients with left atrial (LA) size > 50mm or more or low LA voltage. The purpose of this study was to evaluate the efficacy and safety of additional POBI and AL compared to CPVI alone in persistent AF patients with LA size over 50mm. Also, we intend to proceed with this randomized clinical trial with the high power short duration ablation protocol, which is effective in shortening the procedure time.
Detailed description
- Study design
- Prospective randomization (pulmonary vein isolation [PVI] group vs. additional posterior box isolation [POBI] group vs. additional POBI and anterior line [AL] group)
- Target number of subjects: 480 (160 per group)
- Rhythm follow-up : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.
- Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Follow-up at 1 weeks, 3 months, and thereafter every 6-month after procedure.
- Rhythm control at 3 months, and thereafter every 6-month follow-up with Holter
- If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.
- Follow-up All the patients will be followed-up at 1, 3, 6 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Circumferential pulmonary vein isolation(CPVI) group | Active comparator | Procedure: Circumferential pulmonary vein isolation(CPVI) group |
| Posterior box isolation(POBI) group | Experimental | Procedure: Posterior box isolation(POBI) group |
| POBI+Anterior linear ablation(AL) group | Experimental | Procedure: POBI+Anterior linear ablation(AL) group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with persistent atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
- Left atrium size ≥ 50mm
- Persistent atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
- Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)
Key exclusion criteria (12 listed)
- AF Patients with LA size less than 50mm
- Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
- Patients with severe renal impairment or CT imaging difficulty using contrast media
- Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
- Patients with active internal bleeding
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 |
|---|---|---|
| Circumferential pulmonary vein isolation(CPVI) group1. PVI(pulmonary vein isolation) will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. Evaluation of procedure time, radiofrequency ablation time 4. Evaluation of the complication after the procedure. 5. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. | Procedure or surgery | Circumferential pulmonary vein isolation(CPVI) group |
| Posterior box isolation(POBI) group1. PVI will be performed using a radiofrequency catheter 2. Additional POBI(Posterior box isolation) is performed according to the traditional method and experience of the practitioner. 3. Esophageal temperature will be monitored to prevent esophageal injury. 4. The bidirectional block of each lesion set is the target of the procedures. But, we remain the incomplete block if three times of linear ablation failed to achieve the bidirectional block for the safety purpose. 5. Evaluation of procedure time, radiofrequency ablation time 6. Evaluation of the complication after the procedure. 7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. | Procedure or surgery | Posterior box isolation(POBI) group |
| POBI+Anterior linear ablation(AL) group1. PVI, POBI will be performed using a radiofrequency catheter 2. Additional AL(anterior linear) ablation is performed according to the traditional method and experience of the practitioner. 3. Esophageal temperature will be monitored to prevent esophageal injury. 4. The bidirectional block of each lesion set is the target of the procedures. But, we remain the incomplete block if three times of linear ablation failed to achieve the bidirectional block for the safety purpose. 5. Evaluation of procedure time, radiofrequency ablation time 6. Evaluation of the complication after the procedure. 7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design. | Procedure or surgery | POBI+Anterior linear ablation(AL) group |
Primary outcome
Safety evaluation: Procedure-related cardiac complication rate
Time frame: within 30 days post procedure
-including open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications within 30 days post procedure.
Efficacy evaluation: clinical recurrence rate
Time frame: Within 1 year after 3 months of procedure
- Defined as atrial fibrillation or atrial tachycardia > 30 sec after 3 months within 1 year; based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Efficacy evaluation: Major cardiovascular event rate
Time frame: immediate after procedure
- death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Efficacy evaluation: Major cardiovascular event rate
Time frame: 12 months after procedure
- death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
5 secondary outcomes
procedure time
Time frame: immediate after the procedure
hospitalization duration
Time frame: immediate after the discharge
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
Time frame: immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure.
rate of electrical cardioversion
Time frame: immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure.
rate of cardiovascular hospitalization
Time frame: immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Hui-Nam Pak principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumferential pulmonary vein isolation(CPVI) group, Posterior box isolation(POBI) group and POBI+Anterior linear ablation(AL) group 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 4 inclusion and 12 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 17 Nov 2020. 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 (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?
Safety evaluation: Procedure-related cardiac complication rate (time frame: within 30 days post procedure). The study lists 4 primary outcomes in all. 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 17 Nov 2020.