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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Safety evaluation: Procedure-related cardiac complication rate — 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 — 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 3 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

Trial sites (1)

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