Phase-Aligned Atrial Fibrillation Mapping

NCT ID: NCT06892561

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 336 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-16
• Study Completion Date: 2026-08-16

Brief Summary

Cardiac arrhythmia in the upper chamber of the heart (atrial fibrillation) can be cured by burning. Physicians burn very small pieces of abnormal tissue. It is important to know where to burn. The investigators propose a new way to find out where to burn. The investigators will use a new way to analyze electrical signals inside the heart and build a new electric map. The study may lead to the development of new technology. In the future, novel technology may increase the success rate and the number of cured atrial fibrillation patients. This study is a retrospective study of data collected during routine clinical care: atrial fibrillation ablations. The investigators will compare intracardiac electrograms and atrial activation maps in patients who had successful ablation outcomes (no recurrence within 1 year) and those who experienced a recurrence of arrhythmia within 1 year after the procedure.

Detailed Description

Atrial fibrillation (AF) ablation is an important treatment strategy, potentially capable of curing AF. However, there is a variable degree of success of the persistent AF ablation procedure. Therefore, it is necessary to improve the success rate of persistent AF ablation. To improve the success rate of persistent AF ablation, the investigators proposed a novel analytical approach to AF mapping. Analysis of intracardiac electrograms (EGMs) is the key component of AF mapping. In the past, several approaches to atrial EGM analysis have been developed, aiming to help guide AF ablation beyond pulmonary vein isolation (PVI). However, none (except PVI) have been established to guide the AF catheter ablation procedure. The most widely used approach for AF ablation is an empiric, anatomic AF ablation approach (PVI). Previously tested (and ultimately failed) methods included complex fractionated atrial electrogram (CFAÉ), dominant frequency (DF) mapping, activation (FIRM) mapping, and fibrosis-detected-by-CMR-mapping AF ablation. A novel solution to the known AF mapping problem is necessary to improve AF ablation outcomes. Successful completion of the proposed project will suggest a path to improve the success rate of persistent AF ablation, which is crucially necessary for further progress in the cardiac electrophysiology field. The investigators proposed a novel analytical approach. The investigators will apply phase-aligned spectral filtering to AF atrial EGM mapping data to identify spatially structured dynamic components and thus identify AF ablation targets. Spectral filtering is an efficient dimension reduction for high-dimensional time series, which has not been applied to AF mapping data analysis. Such an approach assumes that the observed spatiotemporal data (AF EGM mapping data) represent superimposed lower-rank smooth oscillations and movements from a dynamic generative system (AF ablation target) mixed with higher-rank random noises. Separating the signals from noises is essential for us to locate and understand these lower-rank dynamic systems. It could be that such a lower-rank dynamic system has multiple independent components corresponding to different trends or functionalities of the system. The investigators propose a novel framework for identifying lower-rank dynamics and their components embedded in a high-dimensional spatiotemporal system (AF EGM map). It is based on a known statistical approach of structural decomposition and phase-aligned construction in the frequency domain, which has not been applied to AF EGM analysis.

Conditions

Atrial Fibrillation (AF)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

successful persistent AF ablation

Cases are defined as successful persistent AF ablation cases (documented freedom from AF during ≥1 year after ablation).

No interventions assigned to this group

failed persistent AF ablation

Controls are defined as failed persistent AF ablation (recurrent, persistent AF in patients with documented well-isolated pulmonary veins).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Records of patients with persistent AF who underwent pulmonary vein isolation (PVI) with any additional AF ablation strategy with available stored digital AF mapping data. Persistent AF is defined as AF lasting more than 7 days.

2. One/First AF ablation procedure (no prior atrial ablation procedures)

3. Documented complete pulmonary vein isolation at the end of the ablation

4. Available uniform, high-quality (as described below) clinical data required to detect AF recurrence during ≥ 1 year after ablation, and/or ECG monitoring (implantable loop recording or repeated long-term ECG monitoring via ECG patch or similar)

Exclusion Criteria

1. Familial AF, AF as a syndrome in rare diseases (cardiomyopathies / WPW/ channelopathies).

2. Missing data of exposure (AF ablation map), outcome (definition of cases and controls), or covariates

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Larisa Tereshchenko, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Larisa Tereshchenko, MD, PhD

Staff, Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Related Links

https://proposalcentral.com/Insights/yK3zgRfRQcI=/Public/AwardDetails/1054947

American Heart Association Award

Other Identifiers

23IPA1054947

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

23IPA1054947

Identifier Type: -

Identifier Source: org_study_id