NCT03920917

Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Paroxysmal Atrial Fibrillation: Prospective Randomized Trial (CRAPAF Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal atrial fibrillation, and it can reduce the procedure time compared to conventional radiofrequency (RF) catheter ablation. Recently, high-power short-duration RF ablation has been known to reduce procedure time remarkably, and it can eliminate extra-pulmonary vein foci, which cannot be treated by Cryoballoon ablation. The aim of this study is to compare Cryoballoon ablation and high-power short-duration RF ablation in patients with paroxysmal atrial fibrillation in terms of the efficacy and the safety in a prospective randomized trial.

Detailed description

A. Study design 1. Prospective randomization (cryoballoon PV isolation group vs. Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation) (Using the Python program, a random number module is imported with the import random syntax, and the random number table for the two groups is created.) 2. Target number of subjects: 330 (165 per group) 3. Rhythm FU : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 3,6 month, and thereafter every 6 months to 24 month, then 1 year; 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, 3,6 months, and thereafter every 6-month after procedure. 3. Rhythm control at 3,6 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 weeks, 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 3, 6 months, and thereafter 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

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Cryoballoon Pulmonary Vein isolation	1. Pulmonary vein isolation will be performed using a cryoballoon catheter. 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. A 28mm second or third cryoballoon catheter will be used. 4. Esophageal temperature will be monitored to prevent esophageal injury. 5. Cryoablation will be performed for 180 secs at -45°C or below on condition that the pulmonary vein is occluded with a cryoballoon. 6. CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein. 7. The procedure and cryoablation times will be evaluated. 8. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
PROCEDURE	Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation	1. Pulmonary vein isolation will be performed using a radiofrequency catheter. 2. Additional cavo-tricuspid isthmus ablation will be performed with a radiofrequency catheter. 3. Additional superior vena cava-right atrial septal linear ablation will be performed with a radiofrequency catheter. 4. If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed. 5. Evaluated the procedure and radiofrequency ablation time. 6. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Timeline

• Start date: 2019-04-03
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2019-04-19
• Last updated: 2021-01-05

Locations

1 site across 1 country: South Korea