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

Not Applicable

• Conditions: Atrial fibrillation; D001281

• Registration Number: JPRN-jRCT1052210122
• Lead Sponsor: Shizuta Satoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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).