optimal ablation InDEx for Atrial fibriLlation during extensive encircling Pulmonary Vein Isolation study

JRCT ID: jRCT1052210122

Registered date:17/11/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 17/11/2021
• Target sample size: 200
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: 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)
• Secondary Outcome: 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).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Shizuta Satoshi