Atrial Fibrillation (AF)NCT06892561
Phase-Aligned Atrial Fibrillation Mapping
An observational study of Atrial Fibrillation (AF), run by Larisa Tereshchenko, MD, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2023to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Keywords
- atrial fibrillation, pulmonary vein isolation, case-control study
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Persistent AF ablation outcome
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).
Measured: 1 year after AF ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start16 Aug 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larisa Tereshchenko, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor-investigator, Larisa Tereshchenko, MD, PhD, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892561
- Sponsor's protocol ID
- 23IPA1054947
- Other IDs
- 23IPA1054947
- Status last verified
- Jun 2026
- First submitted
- 19 Mar 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Mapping Using Phase-Aligned Spectral Filtering for Decomposing Spatiotemporal Dynamics
- ClinicalTrials.gov ID
- NCT06892561
- Acronym / sponsor ID
- 23IPA1054947
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation, pulmonary vein isolation, case-control study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Larisa Tereshchenko, MD, PhDUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- American Heart Association AwardLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by Larisa Tereshchenko, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent AF ablation outcome (time frame: 1 year after AF ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.