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Randomized Controlled Trial
. 2025 Aug;36(8):1999-2010.
doi: 10.1111/jce.16772. Epub 2025 Jun 23.

Efficacy of additional ExTRa Mapping-guided substrate ablation beyond pulmonary vein isolation in persistent atrial fibrillation: The ROTATE trial

Tetsuma Kawaji  1   2 , Takanori Aizawa  2 , Satoshi Shizuta  2 , Saki Yamano  1 , Misaki Naka  1 , Bingyuan Bao  1 , Shun Hojo  1 , Shintaro Matsuda  1 , Masashi Kato  1 , Takafumi Yokomatsu  1 , Shinji Miki  1
Affiliations
Randomized Controlled Trial

Efficacy of additional ExTRa Mapping-guided substrate ablation beyond pulmonary vein isolation in persistent atrial fibrillation: The ROTATE trial

Tetsuma Kawaji et al. J Cardiovasc Electrophysiol. 2025 Aug.

Abstract

Introduction: There are currently no established effective additional substrate ablation strategies beyond pulmonary vein isolation (PVI) for persistent atrial fibrillation (AF).

Objective: This randomized clinical trial evaluated the efficacy of a novel substrate ablation technique using the ExTRa Mapping system, which visualizes rotational activation during AF rhythm.

Methods: This study included 80 patients undergoing initial catheter ablation for persistent AF. Eighty patients whose AF persisted after PVI and ExTRa Mapping were randomly assigned in a 1:1 ratio to either PVI alone or PVI plus ExTRa Mapping-guided substrate ablation targeting areas with high non-passively activated ratio(%NP)( ≥ 35%)(ExTRa group). The primary outcome measure was recurrence of atrial tachyarrhythmias after a 90-day blanking period postablation.

Results: Post-PVI ExTRa Mapping assessed a median of 36 sites per patient in both atria. Baseline characteristics were comparable between groups. The ExTRa group showed higher event-free survival from the primary outcome compared to the PVI alone group (85.0% vs. 67.5% at 1-year, p = 0.07). This favorable prognosis was more pronounced for patients with a large( ≥ 12 sites) area of rotational activation area (81.0% vs. 57.9% at 1-year, p = 0.01). Multivariable analysis identified the number of high %NP areas as an independent risk factor for recurrent tachyarrhythmias (HR 1.13, 95%CI 1.03-1.23, p = 0.005), while ExTRa Mapping-guided substrate ablation emerged as a unique protective factor (HR 0.38, 95%CI 0.13-0.99, p = 0.047).

Conclusion: While the reduction in atrial tachyarrhythmia recurrence of persistent AF patients did not reach statistical significance, the addition of ExTRa Mapping™-guided substrate ablation beyond PVI demonstrated promising potential, especially in patients with larger rotational activation areas.

Keywords: ExTRa mapping; atrial fibrillation; atrial fibrillation driver; catheter ablation; persistent atrial fibrillation.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Study flow chart. AF = atrial fibrillation; PVI = pulmonary vein isolation.
Figure 2
Figure 2
Recurrent atrial tachyarrhythmias. (A) Primary outcome measure: event free survival from recurrent atrial tachyarrhythmias after a 90‐day postablation blanking period, (B) Early recurrence within 90 days after the procedure, (C) Primary outcome measure in patients with and without large high %NP area (≥ 12 sites). PVI = pulmonary vein isolation; %NP=the non‐passively activated ratio.
Figure 3
Figure 3
Types of recurrent atrial tachyarrhythmias. AF = atrial fibrillation; AT = atrial tachycardia.
Figure 4
Figure 4
Sub‐group analysis for the primary outcome measure. Low body weight indicates < 55 kg in men and < 50 kg in women. AF = atrial fibrillation; CI = confidence interval; HR = hazard ratio; PVI = pulmonary vein isolation; %NP = the non‐passively activated ratio.
See this image and copyright information in PMC

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