Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05743829 |
| Other study ID # |
RHM CAR0630 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2023 |
| Est. completion date |
March 1, 2024 |
Study information
| Verified date |
February 2023 |
| Source |
University Hospital Southampton NHS Foundation Trust |
| Contact |
Waqas Ullah, PhD |
| Phone |
07941461222 |
| Email |
waqas[@]doctors.org.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Atrial Fibrillation (AF) is an abnormal rhythm of the heart which is increasingly common and
can be associated with serious consequences. We know that AF is associated with an increase
in the scarring of the heart, the left atrium and it is thought that this scarring may be one
of the drivers for this abnormal heart rhythm. The nature of this scarring in humans has been
subject to limited study and generally only by indirect means such as cardiac MRI scans or
measuring the voltage of the tissues. During cardiothoracic surgery, tissue from the left
atrium is removed as a part of the procedure. This tissue is normally disposed of, but we
would propose to consent patients to collect it to allow it to be analysed. Such analysis
would examine the composition of the tissue, including the pattern of scarring, to allow us
to gain a greater insight into the mechanisms of AF.
Description:
During cardiac surgery, a randomised trial has shown that surgical exclusion of the LAA at
the time of cardiac surgery is associated with a 2.2% reduction in ischaemic stroke and
systemic embolism. Therefore, surgical exclusion of the LAA, which in the latter study was
most commonly achieved by excision, is a well-recognised part of routine surgical practice
for patients with AF. During lung resections for malignancies, irrespective of a history of
AF, along with the part of the lung being resected, the pulmonary vein and surrounding
portion of the left atrium are also removed. These operations therefore provide tissue which
is known to be of great importance in promoting and sustaining AF, but which is normally
discarded.
In the current study proposal, we will obtain this tissue and analyse it histologically. In
the first instance, as a pilot study of up to 10 patients to assess the feasibility of such
an analysis. This sample size is informed by our previous basic science studies of cardiac
and lung fibrosis and will inform the design of a future full study. We aim to obtain samples
from patients in sinus rhythm (thoracic surgical patients) and varying durations of AF (all
surgical cases) to encompass tissues with different degrees of fibrosis.
Design of research Up to 10 patients undergoing cardiothoracic surgery at University Hospital
Southampton NHS Foundation Trust (UHS) will be recruited. In all cases, the patients would be
undergoing surgery where the tissue being studied in the protocol would normally be removed.
In the case of thoracic surgical patients, this would be those undergoing lung resections
where an ostial pulmonary vein segment will be excised. Here the aim will be to have at least
one patient with no history of atrial fibrillation, paroxysmal AF and persistent AF. Cardiac
surgical patients included will be those where surgical left atrial exclusion will be
performed as part of the procedure, in this case at least one patient with paroxysmal and one
with persistent AF.
