The Randomized Controlled Trial Evaluating Utility of Catheter Ablation Us ing ExTRa mapping for Atrial Fibrillation

JRCT ID: jRCT1052210026

Registered date:17/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 22/06/2021
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Atrial sites of high %NP (%NP >35% and LVZ <0.5mV for the first 20 pts., and %NP >35% for the ne xt 20 pts) were ablated, and electr ical car diversio n was performed when sinus resta nd electrical ca rdiversion was performed when sin us restoration was not obtained in 15 minutes afte r injection of Nifekalant 0.3mg/kg.

Outcome(s)

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

Secondary Outcome

Atrial fibrillation termination rate
Atrial fibrillation-free survival, atrial tachycardia-free survival
Procedure detail (procedure time, ablation number, ablation region)
Adverse events
Atrial arrhythmia recurrence beyond 90 days after repeat procedures
The difference of results compared between the different ExTRa-guide ablatio n in combined data with CONTROL-AF study

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 whose atrial fibrillation was restored after only pulmonay veins isolation
Patients who received ablation procedure or MAZE procedure for for atrial fibrillation before enrollment

Related Information

• Primary Sponsor: Shizuta Satoshi
• Secondary ID(s): UMIN000043393