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NCT05993104Withdrawn

Shape vs Substrate in AF

Investigating the Interplay of Left Atrial Geometry With Abnormal Propagation Patterns in Atrial Fibrillation

Source: ClinicalTrials.gov · Last updated 21 Feb 2024

Reason given: Funder no longer operating so the study team is unable to deliver the study.

Brief summary (registry, in English)

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.

Status (registry)
Withdrawn
Study type
Observational
Enrollment
0 (actual)
First submitted
5 Jul 2023
Start date
Jan 2024
Primary completion date
Sept 2026
Lead sponsor
Oxford University Hospitals NHS Trust
NCT number
NCT05993104

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Congenital cardiac abnormality.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant 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.

Who the study is looking for

  • Retrospective component:
  • Participant gave consent for anonymised data being utilised for clinical research at time of procedure.
  • Male or Female, aged 18 years or above.
  • Previous AcQMap guided ablation for paroxysmal or persistent atrial fibrillation.
    • Prospective component:
  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosed with paroxysmal or persistent atrial fibrillation and planned for an AcQMap guided catheter ablation procedure.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
John Radcliffe HospitalOxfordUnited KingdomUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.