Extra ablation beyond puLmonary vein Isolation Nurtures Elimination of atrial fibrillation, or not? (Ext-LINE) Study

JRCT ID: jRCT1052230134

Registered date:22/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 28/11/2023
• Target sample size: 180
• Study type: Interventional
• Intervention(s): In ExTRa mapping-guided ablation group, atrial sites of high %NP (mean %NP >35% and low voltage <0.5 mV ) were ablated and ExTRa mapping-guided anatomical line ablation was added after pulmonary vein isolation, and then electrical cardiversion was performed when sinus restoration was not obtained in 15 minutes after injection of Nifekalant 0.3mg/kg.

Outcome(s)

• Primary Outcome: Atrial arrhythmia recurrence beyond 90 days after catheter ablation for atrial fibrillation

Secondary Outcome

Cardiac function after procedure
Atrial fibrillation-free survival, atrial tachycardia-fre e survival
Atrial fibrillation termination rate
Procedure detail (procedure time, ablation numbe r, ablation region)
Adverse events
Atrial arrhythmia recurrence beyond 90 days after repeat procedures

Key inclusion & exclusion criteria

• Age minimum: >= 21age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

First time ablation procedure for persistent atrial fibrillation
Patients who can be followed for at least 1-year after procedure
Patients from who we get written informed consent

Exclude criteria

Patients with AF termination only by pulmonary vein isolation
Patients who received ablation procedure or MAZE procedure for for atrial fibrillation before enrollment

Related Information

• Primary Sponsor: Nishiwaki Shushi
• Secondary ID(s): UMIN000052490