Phase-Aligned Atrial Fibrillation Mapping

June 29, 2026 updated by: Larisa Tereshchenko, MD, PhD

Atrial Fibrillation Mapping Using Phase-Aligned Spectral Filtering for Decomposing Spatiotemporal Dynamics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
336

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study design: a retrospective case-control study of patients who underwent persistent AF ablation at Cleveland Clinic. The goal of the case-control study is to identify differences in AF mapping (using the proposed novel analytical approach) and persistent AF ablation strategy between the successful and failed persistent AF ablation cases. The selection of cases and controls will pay special attention to well-documented and verified successful and complete pulmonary vein isolation, as failed PVI is a well-known cause of failed AF ablation procedures, but it is not the goal of this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
successful persistent AF ablation
Cases are defined as successful persistent AF ablation cases (documented freedom from AF during ≥1 year after ablation).
failed persistent AF ablation
Controls are defined as failed persistent AF ablation (recurrent, persistent AF in patients with documented well-isolated pulmonary veins).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Persistent AF ablation outcome
Time Frame: 1 year after AF ablation procedure

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Larisa Tereshchenko, MD, PhD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Heart Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23IPA1054947 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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