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

NANot yet recruitingINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

May 31, 2019

Primary Completion Date

March 31, 2029

Study Completion Date

March 31, 2029

Conditions
Valvular Atrial Fibrillation
Interventions
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 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."

Trial Locations (1)

120-752

Severance Cardiovascular Hospital, Yonsei University Health System, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT03920891 - Cryoballoon Pulmonary Vein Isolation vs. Radiofrequency Pulmonary Vein Isolation With Additional Right Atrial Linear Ablation for Valvular Atrial Fibrillation: Prospective Randomized Trial (CRAVA Trial) | Biotech Hunter | Biotech Hunter