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Funder no longer operating so the study team is unable to deliver the study.
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Atrial fibrillation (AF) is an abnormal heart rhythm which originates from the top two chambers (atria) of the heart. It can cause significant symptoms and have severe consequences such as stroke.
Catheter ablation is a treatment for AF. It is minimally invasive, involving thin tubes known as catheters, being inserted through a blood vessel in the groin and passed to the heart under X-ray guidance. Once in the heart, regions of tissue believed responsible for the abnormal heart rhythm can be identified, and hot or cold energy used to create scar at these areas, preventing the abnormal rhythm.
Identifying these regions is a key challenge in making the treatment as effective as possible. The investigators believe that there may be a change in the shape of a participant's atria in these regions and as such identifying and treating areas of abnormal shape may be beneficial.
To investigate this, the study team propose three phases. The first, uses previously collected data to make a model of what is average atrial geometry in AF. Investigators will then compare individual participants' atrial geometries to this average shape to identify areas of geometric abnormality and see how these correspond to areas of abnormal electrical activity. In the second phase, investigators will collect new data on how much atrial geometry changes during catheter ablation procedures. Finally, in the third phase, investigators will investigate whether including geometric assessment in the catheter ablation procedure is feasible from a work flow perspective.
This study will utilise the AcQMap system (Acutus Medical). This is a combined multi-electrode and imaging mapping system, with intra chamber ultrasound used to create a surface mesh of a participant's atrial anatomy. Noncontact charge-density mapping using AcQMap is novel, in that it allows whole chamber conduction to be analysed during AF. This is a distinct advantage over traditional contact mapping techniques, which are unable to globally map the inherently unstable and changing activation patterns occurring in AF. The system's AcQTrack software identifies patterns of localised propagation which may represent AF drivers and displays these on the surface mesh. They are classified as one of three phenomena (localised irregular activation [LIA], localised rotational activity [LRA], focal firing [FF]). AcQMap is the ideal tool for our investigation, given its ability to capture both global AF maps and geometric data. It is utilised routinely in clinical practice and there is an existing rich local dataset of previous cases.
Study Phases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective observational | Retrospective observational arm recruiting >50 participants, utilising data already collected as part of standard clinical care. |
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| Prospective single-arm | Prospective single-arm recruiting 20 participants undergoing AcQMap guided ablation. |
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| Feasibility study | Feasibility study recruiting 10 participants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrachamber ultrasound | Diagnostic Test | Ultrasound left atrial geometry collecting using AcQMap. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regional deformation between participant left atrial geometry and SSM (study phase 1). | Left atria will be partitioned into 6 segments: anterior, posterior, inferior, roof, septal and lateral. Regional deformation is defined by the mean proximity of these segments from their respective closest locations on the SSM. | 1 year. |
| Location of AF drivers defined by AcQTrack (study phase 1). | Location defined using 6 segment model as described above (outcome 1). | 1 year. |
| Frequency of AF drivers defined by AcQTrack (study phase 1). | Frequency of AcQTrack phenomena reported as #/s. | 1 year. |
| Regional change in AcQMap left atrial geometry during ablation procedure (study phase 2). | Regional change defined using 6 segments as per outcome 1. Calculated as mean proximity of these segments during repeated geometry collection from their respective closest locations during initial geometry collection. | 2 years. |
| Completion of additional shape analysis (study phase 3). | 3 years. | |
| Additional procedure time (study phase 3). | 3 years. |
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Inclusion Criteria:
Retrospective component:
Prospective component:
Exclusion Criteria:
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Participants with atrial fibrillation referred to a tertiary hospital (John Radcliffe, Oxford) for ablation.
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| Name | Affiliation | Role |
|---|---|---|
| Tim Betts, MD MBChB FRCP | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Statistical shape analysis | Other | Statistical shape analysis tools used to investigate left atrial geometry |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |