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Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial)
Sponsor: Yonsei University
Summary
Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. We previously reported that the rhythm outcome of radiofrequency (RF) catheter ablations are equivalent in patients with non-valvular atrial fibrillation and in those with surgically and hemodynamically corrected valvular atrial fibrillation. In contrast, the Cryoballoon ablation can reduce the procedure times, it cannot conduct empirical linear ablation or extra-pulmonary vein foci ablation. The aim of this study is to compare Cryoballoon pulmonary vein isolation and RF ablation including linear ablation or extra-pulmonary vein foci ablations in patients with hemodynamically corrected valvular atrial fibrillation.
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2019-05
Completion Date
2029-03
Last Updated
2019-04-19
Healthy Volunteers
No
Conditions
Interventions
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.
Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation
1. Pulmonary vein isolation will be performed using a radiofrequency catheter. 2. Additional left atrium posterior wall isolation, left atrium anterior wall linear ablation, cavo-tricuspid isthmus ablation, superior vena cava-right atrial septal ablation. 3. If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed. 4. Evaluated the procedure and radiofrequency ablation time. 5. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
Locations (1)
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, South Korea