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

Not yet recruiting

• Conditions: Atrial fibrillation

• Registration Number: jRCT1052210122

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-17
• Last Update Posted: 2025-04-10

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: parallel assignment

Primary Outcome Measures

Name	Time	Method
presence of reconduction after waiting		Presence of reconduction after waiting
successful isolation in one round of pulmonary vein energization		Successful isolation in one round of pulmonary vein energization
presence of dormant conduction by ATP administration		Presence of dormant conduction by ATP administration
complications		Safety evaluation: complications
procedure time		Safety evaluation: procedure time
fluoroscopy time		Safety evaluation: fluoroscopy time

Secondary Outcome Measures

Name	Time	Method
Recurrent atrial arrhythmias	12 months	Rate of recurrent atrial arrhythmias lasting longer than 30 seconds