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

The Efficacy of Ultra-High-Resolution Mapping Guided Partial Antral Ablation for Atrial Fibrillation

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03759912
Acronym
TAILOR
Enrollment
75
Registered
2018-11-30
Start date
2018-11-20
Completion date
2021-08-07
Last updated
2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation ablation, Pulmonary vein, Ultra high resolution mapping

Brief summary

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.

Interventions

None listed

Sponsors

Boston Scientific Corporation
CollaboratorINDUSTRY
Keimyung University Dongsan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Age over 20 years old and under 80 years old 2. Patients with non-valvular paroxysmal atrial fibrillation 3. Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. Patients who could have informed consent 5. Patients who are available for a follow-up of more than at least three months after the catheter ablation

Exclusion criteria

1. Patients unsuitable for catheter ablation due to a previous history of pulmonary surgery or structural heart disease 2. Patients who cannot receive standard treatments such as anticoagulation therapy needed before the radiofrequency catheter ablation 3. Patients in the subject group vulnerable to a clinical study 4. Patients who had undergone a prior catheter ablation for atrial fibrillation

Design outcomes

Primary

MeasureTime frameDescription
Atrial arrhythmia recurrenceone yearrecurrence of atrial tachyarrhythmia after the index procedure

Secondary

MeasureTime frameDescription
acute pulmonary vein isolation rateDuring procedurePercentage of patients who are able to obtain pulmonary vein isolation during the procedure
acute pulmonary vein reconnection rateDuring procedurePercentage of patients who achieve pulmonary vein isolation during the procedure but have PV reconnection within the procedure
percentage of ablation area in the antrumDuring procedureArea of pulmonary vein antrum ablated to obtain pulmonary vein isolation
Procedural outcomeDuring procedureprocedure time in minute

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026