Atrial FibrillationBiMap-AFNCT03812601
Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study uses two AcQMap imaging and electroanatomical mapping systems (Acutus Medical) to simultaneously visualise and map patterns of wavefront propagation in both the left and right atria during atrial fibrillation in order to identify mechanisms of rhythm propagation and maintenance and the importance of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Simultaneous bi-atrial electroanatomic mapping and ablation
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Oct 2018to 10 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing their first catheter ablation procedure for atrial fibrillation
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 years or above.
- Diagnosed with paroxysmal or persistent atrial fibrillation and planned for a catheter ablation procedure.
- In the Investigator's opinion is able and willing to comply with all trial requirements.
Who cannot join
- Physical or anatomical barriers to the use of two simultaneous mapping catheters
- Previous cardiac surgery
- Previous ablation (catheter or surgical)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Participants who have participated in another research trial involving an investigational medicinal product in the past 12 weeks. (Involvement in any other research trial is not a contraindication per se.)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation - a Prospective Mechanistic Study
This study uses two AcQMap imaging and electroanatomical mapping systems (Acutus Medical) to simultaneously visualise and map patterns of wavefront propagation in both the left and right atria during atrial fibrillation in order to identify mechanisms of rhythm propagation and maintenance and the importance of the interaction of the left and right atria. Mapping will also be performed during pacing from different sites and cycle lengths to identify regions of abnormal conduction that may be related to the maintenance of atrial fibrillation.
Read the detailed description
Patients undergoing first time catheter ablation for atrial fibrillation with undergo simultaneous bi-atrial mapping using two linked AcQMap imaging and mapping systems from Acutus Medical. Mapping will be performed during AF, sinus rhythm and pacing (following cardioversion if required). Pacing will be undertaken from 3 sites in order to create different vectors of conduction and at varying cycle lengths and coupling intervals in order to identify regions of slow and anisotropic conduction. Patients will then undergo pulmonary vein isolation by radiofrequency ablation followed by ablation of non-pulmonary vein targets at the operators discretion (ablation in line with clinical practice and not as part of the study). Regions of focal firing, rotational or slow conduction during AF will be noted and the interaction between each atria described.
- Conditions
- Atrial Fibrillation
- Being tested
- Simultaneous bi-atrial electroanatomic mapping and 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.
Simultaneous bi-atrial electroanatomic mapping and ablationProcedure or surgery
Simultaneous bi-atrial electroanatomic mapping during atrial fibrillation and during pacing from 3 different vectors at varying cycle lengths followed by pulmonary vein isolation and AcQMap guided ablation of non-pulmonary vein mechanisms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatiotemporal distribution of non-pulmonary vein focal impulses identified during non-contact mapping of atrial fibrillation
The number and location of focal impulses will be collected over 2 recordings
Measured: Catheter ablation procedure
Spatiotemporal distribution of irregular and rotational activation during 2 recordings of atrial fibrillation
Number of sites of irregular and rotational activation (LA and RA) and their frequency over time during 2 recordings of atrial fibrillation
Measured: Catheter ablation procedure
Frequency of inter-atrial wavefront propagation during AF
Proportion of wavefronts originating in each atria activating from left to right and right to left and site of inter-atrial conduction
Measured: Catheter ablation procedure
Secondary outcomes (1)
Outcome of AcQMap guided catheter ablation of atrial fibrillation
Freedom from recurrent atrial fibrillation on 12 lead ECG or >30seconds on ambulatory monitoring
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start11 Oct 2018
- Primary completion10 Sep 2020
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust
- Investigators
- Timothy R Betts, MB ChB, MD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812601
- Sponsor's protocol ID
- 13608
- Acronym
- BiMap-AF
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2019
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation - a Prospective Mechanistic Study
- ClinicalTrials.gov ID
- NCT03812601
- Acronym / sponsor ID
- BiMap-AF / 13608
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 23 Jan 2019 (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 study uses two AcQMap imaging and electroanatomical mapping systems (Acutus Medical) to simultaneously visualise and map patterns of wavefront propagation in both the left and right atria during atrial fibrillation in order to identify mechanisms of rhythm propagation and maintenance and the importance of the interaction of the left and right atria. Mapping will also be performed during pacing from different sites and cycle lengths to identify regions of abnormal conduction that may be related to the maintenance of atrial fibrillation.
Detailed description
Patients undergoing first time catheter ablation for atrial fibrillation with undergo simultaneous bi-atrial mapping using two linked AcQMap imaging and mapping systems from Acutus Medical. Mapping will be performed during AF, sinus rhythm and pacing (following cardioversion if required). Pacing will be undertaken from 3 sites in order to create different vectors of conduction and at varying cycle lengths and coupling intervals in order to identify regions of slow and anisotropic conduction. Patients will then undergo pulmonary vein isolation by radiofrequency ablation followed by ablation of non-pulmonary vein targets at the operators discretion (ablation in line with clinical practice and not as part of the study). Regions of focal firing, rotational or slow conduction during AF will be noted and the interaction between each atria described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing their first catheter ablation procedure for atrial fibrillation
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 years or above.
- Diagnosed with paroxysmal or persistent atrial fibrillation and planned for a catheter ablation procedure.
- In the Investigator's opinion is able and willing to comply with all trial requirements.
Key exclusion criteria (6 listed)
- Physical or anatomical barriers to the use of two simultaneous mapping catheters
- Previous cardiac surgery
- Previous ablation (catheter or surgical)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
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 |
|---|---|---|
| Simultaneous bi-atrial electroanatomic mapping and ablationSimultaneous bi-atrial electroanatomic mapping during atrial fibrillation and during pacing from 3 different vectors at varying cycle lengths followed by pulmonary vein isolation and AcQMap guided ablation of non-pulmonary vein mechanisms. | Procedure or surgery | – |
Primary outcome
Spatiotemporal distribution of non-pulmonary vein focal impulses identified during non-contact mapping of atrial fibrillation
Time frame: Catheter ablation procedure
The number and location of focal impulses will be collected over 2 recordings
Spatiotemporal distribution of irregular and rotational activation during 2 recordings of atrial fibrillation
Time frame: Catheter ablation procedure
Number of sites of irregular and rotational activation (LA and RA) and their frequency over time during 2 recordings of atrial fibrillation
Frequency of inter-atrial wavefront propagation during AF
Time frame: Catheter ablation procedure
Proportion of wavefronts originating in each atria activating from left to right and right to left and site of inter-atrial conduction
1 secondary outcome
Outcome of AcQMap guided catheter ablation of atrial fibrillation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
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Atrial Fibrillation (AF)
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.
Timothy R Betts, MB ChB, MD principal investigator
Oxford University Hospitals NHS Trust
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, run by Oxford University Hospitals 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 4 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 19 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spatiotemporal distribution of non-pulmonary vein focal impulses identified during non-contact mapping of atrial fibrillation (time frame: Catheter ablation procedure). The study lists 3 primary outcomes in all. 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 19 Jan 2022.