- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06892561
Phase-Aligned Atrial Fibrillation Mapping
December 31, 2025 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
Active, not recruiting
Conditions
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
Observational
Enrollment (Actual)
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
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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-
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
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:
- 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.
- One/First AF ablation procedure (no prior atrial ablation procedures)
- Documented complete pulmonary vein isolation at the end of the ablation
- 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:
- Familial AF, AF as a syndrome in rare diseases (cardiomyopathies / WPW/ channelopathies).
- 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 |
|---|
|
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
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
Collaborators
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)
August 16, 2023
Primary Completion (Estimated)
August 16, 2026
Study Completion (Estimated)
August 16, 2026
Study Registration Dates
First Submitted
March 19, 2025
First Submitted That Met QC Criteria
March 19, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
January 5, 2026
Last Update Submitted That Met QC Criteria
December 31, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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