NCT04632550

Giant Left Atrium Atrial fibrillatioN CathEter Ablation, Posterior Box Isolation vs. Dallas Lesion Set

Giant Left Atrium Atrial fibrillatioN CathEter Ablation, Posterior Box Isolation vs. Dallas Lesion Set: Prospective Randomized Trial (GLANCE Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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). 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

A. Study design 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

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2020-11-17
• Last updated: 2020-11-17

Locations

1 site across 1 country: South Korea