The Randomized Controlled Trial Evaluating Utility of Catheter Ablation Us ing New Strategy Targeting Arrhythmogenic Substrate in Atrial Fibrillation Patients

JRCT ID: jRCT1052210010

Registered date:22/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 10/05/2021
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Patients received CARTO FINDER-guided ablation or ExTRa mapping-guided ablation.
In FINDER group, atrial sites of focal activation pattern were ablated, and electrical cardiversion was performed when sinus restoration was not obtained in 15 minutes after injection of Nifekalant 0.3mg/kg.
In ExTRa group, atrial sites of high %NP (%NP >35 % for the first 20 pts., and %NP >35% and LVZ <0. 5mV for the next 20 pts) were ablated, and electrical car diversion was performed when sinus resta nd electrical cardiversion was performed when sin us 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

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 ROTATE study
Study results compared with matched historical control

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 MAZ E procedure for for atrial fibrillation before enrollment

Related Information

• Primary Sponsor: Nishiwaki Shushi
• Secondary ID(s): UMIN000043392