Atrial Flutter TypicalATOMNCT04900831
Validation of Beat-to-beat Wavefront Direction Using Omnipolar Mapping
An observational study of Atrial Flutter Typical, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
To validate omnipolar mapping in a well-described circuit within the heart (Atrial Flutter) and compare it with the gold standard of Local Activation Time (LAT) mapping during routine, clinically indicated procedures of Atrial Flutter ablation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Flutter Typical
- What is being tested?
- Omnipolar Eletroanatomical mapping
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2020to 1 Aug 2022
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with persistent Atrial Flutter that have been listed on a clinical basis to have a Cavotricuspid Isthmus ablation (Atrial Flutter Ablation).
Who may be able to join
- Eligible patients on the waiting list for radiofrequency ablation of Atrial Flutter at the Hammersmith Hospital, Imperial College Healthcare NHS Trust.
- Suitable candidate for catheter mapping/ablation of arrhythmias.
- Eighteen (18) to eighty-five (85) years of age.
- Body Mass Index (BMI) <40 (Wt. in Kgs / Ht. in cm).
- Signed Informed Consent.
Who cannot join
- Severe cerebrovascular disease
- Moderate to severe renal impairment (eGFR<30 ml/min/1.73m2)
- Active gastrointestinal bleeding.
- Active infection or fever.
- Short life expectancy.
- Significant anaemia.
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- Severe uncontrolled systemic hypertension.
- Severe electrolyte imbalance.
- Ejection fraction <35%.
- Congestive heart failure (NYHA IV).
- Unstable angina requiring emergent PTCA (percutaneous transluminal coronary angioplasty) or CABG (Coronary Artery Bypass Grafting).
- Recent myocardial infarction.
- Bleeding or clotting disorders.
- Uncontrolled diabetes.
- Inability to receive IV or oral Anticoagulants.
- Unable to give informed consent (these patients would not be recruited).
- Previous catheter or surgical ablation treatment for Atrial Fibrillation.
- Previous catheter ablation treatment for Atrial Flutter.
- Pregnancy (urinary pregnancy test will be offered on the day of the procedure for all women of reproductive age)
- Drug and/or alcohol abuse.
- Patients who have participated in another study of an investigational medicinal product in the last 3 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
Dimitrios Panagopoulos, +447858778189, d.panagopoulos@nhs.net
Boon Lim, PhD
About this study
To validate omnipolar mapping in a well-described circuit within the heart (Atrial Flutter) and compare it with the gold standard of Local Activation Time (LAT) mapping during routine, clinically indicated procedures of Atrial Flutter ablation. A conventional, LAT map will be created during the procedure, prior to treatment, to guide the procedure. A repeat map will be performed after ablation during the procedure. The investigators will export the map files for off-line analysis with the omnipolar software.
Read the detailed description
Electroanatomical mapping of the chambers of the heart has revolutionised the way physicians treat heart rhythm disorders. However, there still are technical limitations that prevent us from gathering information that could be used to understand and treat these abnormal circuits in more detail.
The gold standard technique in creating electrical maps of the heart in stable circuits is the Local Activation Time (LAT) map. This map is formed by using a stable electrical point (one of the electrode catheters within the heart - plastic tubes with metallic sensors at the end) as a zero point and then collecting electrical data from around the heart based on timings off of that point. This data is then loaded on a licenced software that creates the map. These maps are very useful in creating electrical maps of the heart in relatively stable electrical circuits and can give us information on how the electrical current travels through the heart tissue. These are widely used in guiding ablation by helping us locate areas to ablate (apply local radiofrequency and burn part of the circuit, deactivating it).
In more unstable circuits, such as in Atrial Fibrillation (chaotic electrical activity at the top left chamber of the heart), there are a lot of limitations of this technology as the electrical current changes from heart beat to heart beat and there is no stable zero point In the circuit to "anchor" the map in time. In these situations real-time map creation with local electrical currents would be ideal as it would help us see the direction the electrical wave front travels in real time. Our current electrical catheters have certain limitations which mainly have to do with difficulty in local electrical discrimination and detection of the orientation of the electrical current in real time.
The Advisor HD Grid catheter by Abbott UK can overcome this hurdle. It has a special electrode configuration (4 by 4) that creates 9 distinct anatomical spaces within the catheter grid that can "triangulate" micro current direction in real time (omnipolar mapping). This will greatly enhance our ability to quickly detect electrical wave fronts in unstable circuits such as Atrial Fibrillation which will lead to better understanding of the arrhythmia and identify targets for treatment quickly and efficiently.
The investigators aim to first validate the robustness of omnipolar mapping in a well-described, stable circuit such as Atrial Flutter, and compare it to the gold standard of LAT mapping. This will then help pave the way for use of this technology in more complex circuits, such as Atrial Fibrillation.
- Conditions
- Atrial Flutter Typical
- Being tested
- Omnipolar Eletroanatomical mapping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnipolar Eletroanatomical mappingDiagnostic test
Analyse intracardiac EGMs collected with the HD Grid catheter (Abbott, Chicago, IL) during routine Atrial Flutter ablation using the Omnipolar algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Diagnostic Test: Omnipolar Eletroanatomical mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omnipolar real time wavefront direction is non inferior to LAT map.
Maps will be compared post EP Study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start18 Jun 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Flutter TypicalStudies 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
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900831
- Sponsor's protocol ID
- 19HH5064
- Acronym
- ATOM
- Status last verified
- Jan 2022
- First submitted
- 20 May 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Beat-to-beat Wavefront Direction Using Omnipolar Mapping
- ClinicalTrials.gov ID
- NCT04900831
- Acronym / sponsor ID
- ATOM / 19HH5064
- Conditions
- Atrial Flutter Typical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 25 May 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.
To validate omnipolar mapping in a well-described circuit within the heart (Atrial Flutter) and compare it with the gold standard of Local Activation Time (LAT) mapping during routine, clinically indicated procedures of Atrial Flutter ablation. A conventional, LAT map will be created during the procedure, prior to treatment, to guide the procedure. A repeat map will be performed after ablation during the procedure. The investigators will export the map files for off-line analysis with the omnipolar software.
Detailed description
Electroanatomical mapping of the chambers of the heart has revolutionised the way physicians treat heart rhythm disorders. However, there still are technical limitations that prevent us from gathering information that could be used to understand and treat these abnormal circuits in more detail.
The gold standard technique in creating electrical maps of the heart in stable circuits is the Local Activation Time (LAT) map. This map is formed by using a stable electrical point (one of the electrode catheters within the heart - plastic tubes with metallic sensors at the end) as a zero point and then collecting electrical data from around the heart based on timings off of that point. This data is then loaded on a licenced software that creates the map. These maps are very useful in creating electrical maps of the heart in relatively stable electrical circuits and can give us information on how the electrical current travels through the heart tissue. These are widely used in guiding ablation by helping us locate areas to ablate (apply local radiofrequency and burn part of the circuit, deactivating it).
In more unstable circuits, such as in Atrial Fibrillation (chaotic electrical activity at the top left chamber of the heart), there are a lot of limitations of this technology as the electrical current changes from heart beat to heart beat and there is no stable zero point In the circuit to "anchor" the map in time. In these situations real-time map creation with local electrical currents would be ideal as it would help us see the direction the electrical wave front travels in real time. Our current electrical catheters have certain limitations which mainly have to do with difficulty in local electrical discrimination and detection of the orientation of the electrical current in real time.
The Advisor HD Grid catheter by Abbott UK can overcome this hurdle. It has a special electrode configuration (4 by 4) that creates 9 distinct anatomical spaces within the catheter grid that can "triangulate" micro current direction in real time (omnipolar mapping). This will greatly enhance our ability to quickly detect electrical wave fronts in unstable circuits such as Atrial Fibrillation which will lead to better understanding of the arrhythmia and identify targets for treatment quickly and efficiently.
The investigators aim to first validate the robustness of omnipolar mapping in a well-described, stable circuit such as Atrial Flutter, and compare it to the gold standard of LAT mapping. This will then help pave the way for use of this technology in more complex circuits, such as Atrial Fibrillation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Omnipolar Eletroanatomical mapping |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent Atrial Flutter that have been listed on a clinical basis to have a Cavotricuspid Isthmus ablation (Atrial Flutter Ablation).
Key inclusion criteria (5 listed)
- Eligible patients on the waiting list for radiofrequency ablation of Atrial Flutter at the Hammersmith Hospital, Imperial College Healthcare NHS Trust.
- Suitable candidate for catheter mapping/ablation of arrhythmias.
- Eighteen (18) to eighty-five (85) years of age.
- Body Mass Index (BMI) <40 (Wt. in Kgs / Ht. in cm).
- Signed Informed Consent.
Key exclusion criteria (21 listed)
- Severe cerebrovascular disease
- Moderate to severe renal impairment (eGFR<30 ml/min/1.73m2)
- Active gastrointestinal bleeding.
- Active infection or fever.
- Short life expectancy.
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 |
|---|---|---|
| Omnipolar Eletroanatomical mappingAnalyse intracardiac EGMs collected with the HD Grid catheter (Abbott, Chicago, IL) during routine Atrial Flutter ablation using the Omnipolar algorithm. | Diagnostic test | Group 1 |
Primary outcome
Omnipolar real time wavefront direction is non inferior to LAT map.
Time frame: 1 year
Maps will be compared post EP Study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No. No IPD will be shared.
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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.
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 Flutter Typical, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 5 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 10 Feb 2022. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitrios Panagopoulos (+447858778189, d.panagopoulos@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omnipolar real time wavefront direction is non inferior to LAT map. (time frame: 1 year). 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 10 Feb 2022.