Giant Left Atrium Atrial fibrillatioN CathEter Ablation, Posterior Box Isolation vs. Dallas Lesion Set
NCT ID: NCT04632550
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
480 participants
INTERVENTIONAL
2020-12-31
2025-10-31
Brief Summary
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Detailed Description
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1. Prospective randomization (pulmonary vein isolation \[PVI\] group vs. additional posterior box isolation \[POBI\] group vs. additional POBI and anterior line \[AL\] group)
2. Target number of subjects: 480 (160 per group)
3. 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)
4. Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
5. All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.
B. Progress and rhythm/ECG follow-up
1. To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
2. Follow-up at 1 weeks, 3 months, and thereafter every 6-month after procedure.
3. Rhythm control at 3 months, and thereafter every 6-month follow-up with Holter
4. 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.
C. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Circumferential pulmonary vein isolation(CPVI) group
Circumferential pulmonary vein isolation(CPVI) group
1. 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.
Posterior box isolation(POBI) group
Posterior box isolation(POBI) group
1. 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.
POBI+Anterior linear ablation(AL) group
POBI+Anterior linear ablation(AL) group
1. 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.
Interventions
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Circumferential pulmonary vein isolation(CPVI) group
1. 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.
Posterior box isolation(POBI) group
1. 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.
POBI+Anterior linear ablation(AL) group
1. 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.
Eligibility Criteria
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Inclusion Criteria
2. Left atrium size ≥ 50mm
3. Persistent atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
4. Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)
Exclusion Criteria
2. Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
3. Patients with severe renal impairment or CT imaging difficulty using contrast media
4. Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
5. Patients with active internal bleeding
6. Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
7. Patients with valvular atrial fibrillation (mitral stenosis \>grade 2, mechanical valve, mitral valvuloplasty)
8. Patients with a severe comorbid disease
9. Expected survival \< 1 year
10. Drug addicts or alcoholics
11. Patients who cannot read the consent form (illiterates, foreigners, etc.)
12. Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study
20 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Hui-Nam Pak
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Yonsei Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Hui-Nam Pak
Role: primary
Other Identifiers
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4-2020-0954
Identifier Type: -
Identifier Source: org_study_id