NCT03759912: TAILOR

Ultra-High-Resolution Mapping Guided Partial Antral Ablation for AF

Terminated Last updated 31 May 2023

What this trial tests

trial in Atrial Fibrillation in 75 participants. Terminated before completion.

Timeline

20 November 2018

Primary endpoint
5 August 2020

7 August 2021

Quick facts

Lead sponsor	Keimyung University Dongsan Medical Center
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	75
Start date	20 November 2018
Primary completion	5 August 2020
Estimated completion	7 August 2021
Sites	1 location across South Korea

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Keimyung University Dongsan Medical Center

Who can join

Adults 20 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation techniques for the treatment of atrial fibrillation (AF) because the PV is the most common trigger of AF. Wide bi-antral circumferential ablation (WACA) is more effective than segmental PV isolation in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up. Therefore, it is widely accepted as initial ablation strategy. However, the WACA technique requires a much larger number of ablation and higher energy to achieve complete isolation because of thick atrial myocardial sleeves with multiple muscle layers present in most of the PV antrum, which is less likely to achieve homogenous transmural lesions in the entire circumference with the currently available ablation technologies. Meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human PV-Left atrium (LA) junction are previously reported, and electrical PV isolation can usually be achieved without complete circumferential ablation. However, the current electroanatomical mapping (EAM) system has a limitation to understand the complex relationship of PV-LA junction mainly due to relatively low resolution.

The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion, Boston Scientific). Owing to better resolution, this new system capable of rapidly and accurately identify critical isthmuses and low-voltage regions of interest and also allows automatic acquisition and accurate annotation of the electrograms, without the need for manual correction.

In this context, we hypothesized that rapid and precise identification of activation pattern of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of PVs without circumferential antral ablation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.