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

Atrial Fibrillation Clinical Trial

— TAILOR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03759912
• Other study ID #: 2018-07-008
• Status: Terminated
• Start date: November 20, 2018
• Est. completion date: August 7, 2021

Study information

• Verified date: May 2023
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: August 7, 2021
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu

Sponsors (2)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center	Boston Scientific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial arrhythmia recurrence	recurrence of atrial tachyarrhythmia after the index procedure	one year
Secondary	acute pulmonary vein isolation rate	Percentage of patients who are able to obtain pulmonary vein isolation during the procedure	During procedure
Secondary	acute pulmonary vein reconnection rate	Percentage of patients who achieve pulmonary vein isolation during the procedure but have PV reconnection within the procedure	During procedure
Secondary	percentage of ablation area in the antrum	Area of pulmonary vein antrum ablated to obtain pulmonary vein isolation	During procedure
Secondary	Procedural outcome	procedure time in minute	During procedure
Secondary	Procedural outcome	fluoroscopic time in minute	During procedure
Secondary	Procedural outcome	total ablation time in minute	During procedure
Secondary	Procedural outcome	procedural complications - number of patients who experienced complications	During procedure