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A Multicenter, Randomized, Parallel-Group Study of the Efficacy and Safety of a Low Ablation Index Group versus a High Ablation Index Group during Extensive Encircling Pulmonary Vein Isolation for Atrial Fibrillation

optimal ablation InDEx for Atrial fibriLlation during extensive encircling Pulmonary Vein Isolation study (IDEAL-PVI study)

Shizuta Satoshi

Kyoto University Hospital

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan

shizuta@kuhp.kyoto-u.ac.jp

Nishiwaki Shushi

Kyoto University Hospital

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan

+81-75-751-4255

s_nishiwaki@kuhp.kyoto-u.ac.jp

Pending

Nov. 17, 2021

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

All of the following criteria should be met.
(1) Patients undergoing initial ablation for atrial fibrillation (regardless of duration).
(2) Female/male patients who are aged 20 years or older and 85 years or younger at the time of consent/enrollment.

Patients should be excluded if any of the following conditions apply
(1) Patients with contraindications to anticoagulation.
(2) Patients with thrombus in the left atrium.
(3) Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.

Both

Atrial fibrillation

Low Ablation Index group
The left pulmonary vein is energized with a target Ablation Index of 550 from the canopy to the anterior wall of the carina, and 400 from the anterior wall of the left inferior pulmonary vein to the posterior wall (when the esophageal thermometer reaches 40 degrees, energization is terminated even if 400 is not met). The right pulmonary vein should be energized with a target of 550 from the canopy to the anterior wall and 400 from the base to the posterior wall.
High Ablation Index group
The left pulmonary vein is energized with the following targets: Ablation Index 550-600 from the canopy to the anterior wall of the left superior pulmonary vein, 600-650 for the anterior wall of the left carina, 400 from the anterior wall of the left inferior pulmonary vein to the posterior wall, 500-600 for the posterior wall of the left pulmonary vein, and 400-450 for the superior esophagus. (When the esophageal thermometer reaches 40 degrees, the current flow is terminated even if it does not meet 400.) For the right pulmonary vein, target 600-650 for the anterior wall to base of the right inferior pulmonary vein, 600 for the anterior wall to top of the right superior pulmonary vein, and 550-600 for the posterior wall of the right pulmonary vein.

Atrial fibrillation

Catheter ablation

D001281

D017115

Acute effects of expanded pulmonary vein isolation by High Ablation Index (successful isolation in one round of pulmonary vein energization, presence of reconduction after waiting, presence of dormant conduction by ATP administration)), safety evaluation (complications, procedure time, fluoroscopy time)

Chronic phase effects of expanded pulmonary vein isolation by High Ablation Index (excluding the blanking period within 3 months after ablation, the rate of recurrent atrial arrhythmias lasting longer than 30 seconds at 12 months, status under antiarrhythmic medication, and changes in quality of life).

+81-75-753-4680

Oct. 11, 2021

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