Atrial FibrillationNCT03082963
Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
A study testing Electrogram Morphology Mapping (EMR) in people with Atrial Fibrillation, run by Jeffrey Goldberger at 1 site in United States.
Trial summary
The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Electrogram Morphology Mapping (EMR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2017to 18 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female at least 21 years of age
- persistent Afib with one prior failed ablation for persistent or long standing persistent Afib
Who cannot join
- Inability to sign consent
- Patients with a life expectancy less than one (1) year
- Patients with chronic kidney disease with sufficiently low GFR that precludes either CT angiogram of the heart or contrast MRI study
- Pregnant women and women that are breast feeding
- Patients with multiple (2 or more) prior failed ablations
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to identify potential sites for ablation. Furthermore, this study could help demonstrate the efficacy of this technology's ability to terminate or slow AF.
The Investigator will test this technology on ten subjects undergoing a second ablation procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable activity and ablate the area. The Investigator believes that the study could produce acute AF termination or AF cycle length slowing. In addition to testing the real-time electrogram morphology recurrence mapping, the study would also like to determine the acute effects of radiofrequency ablation of areas of high recurrence rates and determine long term freedom from AF following ablation of areas of high recurrence rates.
- Conditions
- Atrial Fibrillation
- Being tested
- Electrogram Morphology Mapping (EMR)
- Keywords
- atrial fibrillation, ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrogram Morphology Mapping (EMR)Device
Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium \& then the left atrium.
| Study group | Role | What they receive |
|---|---|---|
| EMR Feasibility | Other | In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. Receives: Device: Electrogram Morphology Mapping (EMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility
As measured by number of patients where real-time EMR mapping is completed.
Measured: 2 hours
Secondary outcomes (3)
Ablation Acute Effects
ablation based on EMR map as measured by number of participants that terminate atrial fibrillation.
Measured: 2 hours
Number of Participants With Treatment Emergent Adverse Events
Number of participants with treatment emergent adverse events will be measured by the type of adverse event, severity, and whether the AE/SAE is related to the mapping
Measured: 30 days
Ablation Acute Effects
ablation based on EMR map as measured by number of participants that slow atrial fibrillation cycle length by at least 15%.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start4 Apr 2017
- Primary completion18 Jun 2022
- Study completion18 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Goldberger
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Jeffrey Goldberger, University of Miami
- Investigators
- Raul Mitrani, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082963
- Sponsor's protocol ID
- 20150757
- Other IDs
- 1R41HL127907-01A1
- Status last verified
- Jul 2023
- First submitted
- 27 Feb 2017
- Last updated
- 3 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT03082963
- Acronym / sponsor ID
- 20150757
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jeffrey GoldbergerUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 18 Jun 2022 (actual)
- Study completion
- 18 Jun 2022 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Posted 3 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to identify potential sites for ablation. Furthermore, this study could help demonstrate the efficacy of this technology's ability to terminate or slow AF.
The Investigator will test this technology on ten subjects undergoing a second ablation procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable activity and ablate the area. The Investigator believes that the study could produce acute AF termination or AF cycle length slowing. In addition to testing the real-time electrogram morphology recurrence mapping, the study would also like to determine the acute effects of radiofrequency ablation of areas of high recurrence rates and determine long term freedom from AF following ablation of areas of high recurrence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMR Feasibility | Other | Device: Electrogram Morphology Mapping (EMR)In this feasibility study, all ten patients will undergo EMR mapping which will be used to guide ablation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female at least 21 years of age
- persistent Afib with one prior failed ablation for persistent or long standing persistent Afib
Key exclusion criteria (6 listed)
- Inability to sign consent
- Patients with a life expectancy less than one (1) year
- Patients with chronic kidney disease with sufficiently low GFR that precludes either CT angiogram of the heart or contrast MRI study
- Pregnant women and women that are breast feeding
- Patients with multiple (2 or more) prior failed ablations
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 |
|---|---|---|
| Electrogram Morphology Mapping (EMR)Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium \& then the left atrium. | Device | EMR Feasibility |
Primary outcome
Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility
Time frame: 2 hours
As measured by number of patients where real-time EMR mapping is completed.
3 secondary outcomes
Ablation Acute Effects
Time frame: 2 hours
Number of Participants With Treatment Emergent Adverse Events
Time frame: 30 days
Ablation Acute Effects
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Raul Mitrani, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrogram Morphology Mapping (EMR) in people with Atrial Fibrillation, run by Jeffrey Goldberger 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 3 Aug 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?
Yes. Results are posted in the registry (first posted 3 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility (time frame: 2 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 3 Aug 2023.