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

NCT ID: NCT03759912

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2021-08-07

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PVI using Ultra-High-Resolution Mapping

The paroxysmal atrial fibrillation patients who received pulmonary vein antral catheter ablation for electrical isolation of pulmonary veins using ultra-high-resolution mapping system (Rhythmia High Density mapping system).

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seongwook Han

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seongwook Han, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Keimyung University

Locations

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Countries

South Korea

Other Identifiers

2018-07-008

Identifier Type: -

Identifier Source: org_study_id