Persistent Atrial FibrillationNCT05093868
Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF)
A study testing Electrographic Flow Mapping in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by Corewell Health East at 1 site in United States.
Trial summary
This is a prospective, observational, single center pilot trial to find out if a new computerized technology for analysis of the electrical activity recorded during atrial fibrillation can identify the electrical source of this arrhythmia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
- What is being tested?
- Electrographic Flow Mapping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2022to 2 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo elective catheter ablation of AF
- History of persistent or longstanding persistent AF (see definitions below)
- Able to provide written informed consent prior to the procedure
- Age ≥18 years
Who cannot join
- Ineligible to undergo elective atrial fibrillation ablation procedure due to medical illness or poor medical condition
- Presence of a permanent endocardial pacemaker or ICD (implantable cardioverter defibrillator)
- Presence of a prosthetic mitral heart valve
- Known reversible causes of AF including clinical hyperthyroidism, pericarditis/pleuritis or other active systemic inflammatory disease including post pericardiotomy syndrome, systemic lupus erythematosus, sarcoidosis and rheumatoid arthritis
- Decompensated clinical heart failure (NYHA class 4)
- Any cerebral ischemic event (strokes or transient ischemic attacks) which occurred during the 6-month interval preceding the consent date
Show all 9Show fewer
- History of systemic thromboembolic event defined as clinical and arteriographic evidence of thromboembolism to any distal arterial vascular bed within the past 6 months, or evidence of intracardiac thrombus at the time of the procedure
- Pregnancy (pre-procedure pregnancy serum test will be performed in all premenopausal women)
- Unable to provide own informed consent due to cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Electrographic Flow Mapping VALidation in Patients With Persistent Atrial Fibrillation (EVAL AF)
This is a prospective, observational, single center pilot trial to find out if a new computerized technology for analysis of the electrical activity recorded during atrial fibrillation can identify the electrical source of this arrhythmia. If we are able to reliably identify the source, then in the future we may be able to use this technology to determine the optimal sites for catheter ablation of atrial fibrillation in the heart. The present study will compare the standard electrical recordings to the new computerized algorithm analysis of recordings gathered at the same time. The study will enroll 30 participants with persistent or longstanding persistent atrial fibrillation (AF) that are scheduled for elective catheter ablation of AF. The catheters that are being placed in the heart are standard Food and Drug Administration (FDA)-approved mapping catheters. The investigational computerized software that will be employed in the trial will be used after the case has done and will not directly impact any of the activities during the ablation procedure. Information learned from this trial will improve understanding of the mechanisms of atrial fibrillation and will potentially improve success rates of AF ablation for patients in the future and will be used to design a prospective trial.
Read the detailed description
It is hypothesized that initiation and propagation of atrial fibrillation (AF) is dependent, at least in part, on rapid atrial stimulation from focal sources. It is debated whether the mechanism of arrhythmogenesis at these foci is abnormal automaticity, triggered activity, microreentry or rotational reentry. However, after activation emerges from these "driver" sites, fibrillatory conduction ensues resulting in the disorganized conduction pattern of AF. Conventional mapping systems can either achieve high spatial resolution by sequential tachycardia beats following a fixed intra-atrial activation pattern (as in macro reentrant atrial flutter), or high temporal resolution with very low spatial resolution achieved through multielectrode basket catheters. Activation mapping in AF with commercially available mapping systems has been unsuccessful in identifying driver sites because atrial activation patterns change on a beat-to-beat basis precluding the use of sequential mapping approaches, and real-time mapping with basket electrodes lacks sufficient resolution to delineate the complex patterns of conduction. Electrographic Flow (EGF) mapping (AblaMap®, Ablacon, Inc, Wheat Ridge, CO) is a unique method to assess dominant patterns of intra-atrial conduction during ongoing atrial fibrillation and has been previously described. Recordings from a multielectrode basket catheter are analyzed for electrical activation vectors over sequential 2-second segments during a 60 second acquisition period. Patterns of reproducible vector activation are used to identify driver sources for the AF. Multiple sources are often identified in patients with persistent AF. It is anticipated that substrate modification of these source regions will eliminate the AF drivers and result in a favorable response to catheter ablation.
Participants undergoing elective catheter ablation of AF will be enrolled. During the elective catheter ablation and during ongoing AF, A 64-pole basket mapping catheter (FIRMap™, Abbott Laboratories, Abbott Park, IL) will be inserted into the right atrium, and electrical signals will be passively acquired. This is the only aspect of the procedure that will be research beyond standard of care. A 16-pole HD grid mapping catheter (Advisor™ HD Grid, Abbott Laboratories, Abbott Park, IL) will be inserted into the right atrium and high density electrogram signals will be recorded from each site for 2 minutes. At least 6 sites will be assessed. After transseptal catheterization, mapping of the left atrium will proceed in a similar fashion. Electrogram signals will be recorded in the electroanatomical mapping system as well as the 128-channel electrophysiology recording system. The collected electrogram data will be analyzed post procedure.
- Being tested
- Electrographic Flow Mapping
- Keywords
- electrographic flow mapping, EGF, atrial fibrillation, FIRMap, Abbott Laboratories, EGF Maps, HD Grid Maps
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrographic Flow MappingDevice
Electrographic Flow Mapping will be collected
| Study group | Role | What they receive |
|---|---|---|
| FIRMap™ (Abbott Laboratories, Abbott Park, IL) | Experimental | A 64-pole basket mapping catheter (FIRMap™, Abbott Laboratories, Abbott Park, IL) will be used to passively acquire electrical signals Receives: Device: Electrographic Flow Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with correlation in detection of sources of atrial fibrillation between the electrographic flow (EGF) mapping multielectrode basket catheter and the high-density (HD) regional mapping catheter.
The number of participants will be reported who have the same areas identified for primary sources of AF, secondary sources of AF and passive flow regions, using the two catheter modalities.
Measured: During elective catheter ablation procedure, an average duration of 3 to 6 hours
Secondary outcomes (2)
AF cycle length calculated from EGF mapping catheter
Calculated mean AF cycle length in milliseconds as recorded using the EGF mapping multielectrode basket catheter
Measured: Two-minute time intervals during elective catheter ablation procedure, an average duration of 3-6 hours
AF cycle length calculated from HD grid regional mapping catheter
Calculated mean AF cycle length in milliseconds as recorded using the HD grid regional mapping catheter
Measured: Two-minute time intervals during elective catheter ablation procedure, an average duration of 3-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start2 Sep 2022 (estimated)
- Primary completion2 Sep 2022 (estimated)
- Study completion2 Sep 2022 (estimated)
Why it stopped: Required equipment could not be obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nishaki Mehta, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093868
- Sponsor's protocol ID
- 2021-021
- Status last verified
- Dec 2023
- First submitted
- 14 Oct 2021
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrographic Flow Mapping VALidation in Patients With Persistent Atrial Fibrillation (EVAL AF)
- ClinicalTrials.gov ID
- NCT05093868
- Acronym / sponsor ID
- 2021-021
- Keywords
- electrographic flow mapping, EGF, atrial fibrillation, FIRMap, Abbott Laboratories, EGF Maps, HD Grid Maps
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Required equipment could not be obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 2 Sep 2022 (estimated)
- Primary completion
- 2 Sep 2022 (estimated)
- Study completion
- 2 Sep 2022 (estimated)
- First posted
- 26 Oct 2021 (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.
This is a prospective, observational, single center pilot trial to find out if a new computerized technology for analysis of the electrical activity recorded during atrial fibrillation can identify the electrical source of this arrhythmia. If we are able to reliably identify the source, then in the future we may be able to use this technology to determine the optimal sites for catheter ablation of atrial fibrillation in the heart. The present study will compare the standard electrical recordings to the new computerized algorithm analysis of recordings gathered at the same time. The study will enroll 30 participants with persistent or longstanding persistent atrial fibrillation (AF) that are scheduled for elective catheter ablation of AF. The catheters that are being placed in the heart are standard Food and Drug Administration (FDA)-approved mapping catheters. The investigational computerized software that will be employed in the trial will be used after the case has done and will not directly impact any of the activities during the ablation procedure. Information learned from this trial will improve understanding of the mechanisms of atrial fibrillation and will potentially improve success rates of AF ablation for patients in the future and will be used to design a prospective trial.
Detailed description
It is hypothesized that initiation and propagation of atrial fibrillation (AF) is dependent, at least in part, on rapid atrial stimulation from focal sources. It is debated whether the mechanism of arrhythmogenesis at these foci is abnormal automaticity, triggered activity, microreentry or rotational reentry. However, after activation emerges from these "driver" sites, fibrillatory conduction ensues resulting in the disorganized conduction pattern of AF. Conventional mapping systems can either achieve high spatial resolution by sequential tachycardia beats following a fixed intra-atrial activation pattern (as in macro reentrant atrial flutter), or high temporal resolution with very low spatial resolution achieved through multielectrode basket catheters. Activation mapping in AF with commercially available mapping systems has been unsuccessful in identifying driver sites because atrial activation patterns change on a beat-to-beat basis precluding the use of sequential mapping approaches, and real-time mapping with basket electrodes lacks sufficient resolution to delineate the complex patterns of conduction. Electrographic Flow (EGF) mapping (AblaMap®, Ablacon, Inc, Wheat Ridge, CO) is a unique method to assess dominant patterns of intra-atrial conduction during ongoing atrial fibrillation and has been previously described. Recordings from a multielectrode basket catheter are analyzed for electrical activation vectors over sequential 2-second segments during a 60 second acquisition period. Patterns of reproducible vector activation are used to identify driver sources for the AF. Multiple sources are often identified in patients with persistent AF. It is anticipated that substrate modification of these source regions will eliminate the AF drivers and result in a favorable response to catheter ablation.
Participants undergoing elective catheter ablation of AF will be enrolled. During the elective catheter ablation and during ongoing AF, A 64-pole basket mapping catheter (FIRMap™, Abbott Laboratories, Abbott Park, IL) will be inserted into the right atrium, and electrical signals will be passively acquired. This is the only aspect of the procedure that will be research beyond standard of care. A 16-pole HD grid mapping catheter (Advisor™ HD Grid, Abbott Laboratories, Abbott Park, IL) will be inserted into the right atrium and high density electrogram signals will be recorded from each site for 2 minutes. At least 6 sites will be assessed. After transseptal catheterization, mapping of the left atrium will proceed in a similar fashion. Electrogram signals will be recorded in the electroanatomical mapping system as well as the 128-channel electrophysiology recording system. The collected electrogram data will be analyzed post procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIRMap™ (Abbott Laboratories, Abbott Park, IL) | Experimental | Device: Electrographic Flow MappingA 64-pole basket mapping catheter (FIRMap™, Abbott Laboratories, Abbott Park, IL) will be used to passively acquire electrical signals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo elective catheter ablation of AF
- History of persistent or longstanding persistent AF (see definitions below)
- Able to provide written informed consent prior to the procedure
- Age ≥18 years
Key exclusion criteria (9 listed)
- Ineligible to undergo elective atrial fibrillation ablation procedure due to medical illness or poor medical condition
- Presence of a permanent endocardial pacemaker or ICD (implantable cardioverter defibrillator)
- Presence of a prosthetic mitral heart valve
- Known reversible causes of AF including clinical hyperthyroidism, pericarditis/pleuritis or other active systemic inflammatory disease including post pericardiotomy syndrome, systemic lupus erythematosus, sarcoidosis and rheumatoid arthritis
- Decompensated clinical heart failure (NYHA class 4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrographic Flow MappingElectrographic Flow Mapping will be collected | Device | FIRMap™ (Abbott Laboratories, Abbott Park, IL) |
Primary outcome
Number of participants with correlation in detection of sources of atrial fibrillation between the electrographic flow (EGF) mapping multielectrode basket catheter and the high-density (HD) regional mapping catheter.
Time frame: During elective catheter ablation procedure, an average duration of 3 to 6 hours
The number of participants will be reported who have the same areas identified for primary sources of AF, secondary sources of AF and passive flow regions, using the two catheter modalities.
2 secondary outcomes
AF cycle length calculated from EGF mapping catheter
Time frame: Two-minute time intervals during elective catheter ablation procedure, an average duration of 3-6 hours
AF cycle length calculated from HD grid regional mapping catheter
Time frame: Two-minute time intervals during elective catheter ablation procedure, an average duration of 3-6 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Nishaki Mehta, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrographic Flow Mapping in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by Corewell Health East 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 9 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: withdrawn, as of the sponsor's last update on 28 Dec 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with correlation in detection of sources of atrial fibrillation between the electrographic flow (EGF) mapping multielectrode basket catheter and the high-density (HD) regional mapping catheter. (time frame: During elective catheter ablation procedure, an average duration of 3 to 6 hours). 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 28 Dec 2023.