Atrial FibrillationNCT05743829
Atrial Fibrillation Driver Study
An observational study of Atrial Fibrillation and Fibrosis Myocardial, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Fibrosis Myocardial
- What is being tested?
- Tissue excision as part of routine clinical care
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2023to 14 May 2025
- 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 100 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing cardiac and thoracic surgery
Who may be able to join
- Able to provide informed consent for study
- Male or female subjects between 18 and 100 years of age at the time of consent.
- Thoracic surgical patients either with or without a history of AF undergoing lung resection where an ostial pulmonary vein segment will be excised as part of this resection
- Cardiac surgical patients with a history of AF where surgical LAA exclusion is planned as part of the procedure
Who cannot join
- Patient unable or unwilling to consent
- Patient not having ostial pulmonary vein or left atrial appendage tissue excised as part of routine clinical care.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, Hampshire, SO166YD
About this study
Official title: Atrial Fibrillation Driver Study - Pilot Project
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.
Read the detailed 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.
- Conditions
- Atrial Fibrillation, Fibrosis Myocardial
- Being tested
- Tissue excision as part of routine clinical care
- Keywords
- AF, Fibrosis
- Medical subject headings
- Atrial Fibrillation, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue excision as part of routine clinical careProcedure or surgery
Tissue excision
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery | Patients undergoing cardiac surgery - left atrial appendage excision Receives: Procedure: Tissue excision as part of routine clinical care | |
| Thoracic Surgery | Patients undergoing lung resection - ostial pulmonary vein tissue Receives: Procedure: Tissue excision as part of routine clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological analysis
Immunohistochemistry, in situ hybridisation, electron microscopy, collagen cross-linking
Measured: 1 year
Molecular analysis
genome sequencing, miRNA and RNA sequencing, culture, RT-PCR, flow cytometry and immunocytochemistry
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 posted24 Feb 2023
- Study start4 Jul 2023
- Primary completion14 May 2025
- Study completion14 May 2025
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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waqas Ullah, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743829
- Sponsor's protocol ID
- RHM CAR0630
- Status last verified
- May 2025
- First submitted
- 14 Feb 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data will be anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Driver Study - Pilot Project
- ClinicalTrials.gov ID
- NCT05743829
- Acronym / sponsor ID
- RHM CAR0630
- Conditions
- Atrial Fibrillation, Fibrosis Myocardial
- Keywords
- AF, Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 24 Feb 2023 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery | – | Procedure: Tissue excision as part of routine clinical carePatients undergoing cardiac surgery - left atrial appendage excision |
| Thoracic Surgery | – | Procedure: Tissue excision as part of routine clinical carePatients undergoing lung resection - ostial pulmonary vein tissue |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac and thoracic surgery
Key inclusion criteria (4 listed)
- Able to provide informed consent for study
- Male or female subjects between 18 and 100 years of age at the time of consent.
- Thoracic surgical patients either with or without a history of AF undergoing lung resection where an ostial pulmonary vein segment will be excised as part of this resection
- Cardiac surgical patients with a history of AF where surgical LAA exclusion is planned as part of the procedure
Key exclusion criteria (2 listed)
- Patient unable or unwilling to consent
- Patient not having ostial pulmonary vein or left atrial appendage tissue excised as part of routine clinical care.
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 |
|---|---|---|
| Tissue excision as part of routine clinical careTissue excision | Procedure or surgery | Cardiac Surgery, Thoracic Surgery |
Primary outcome
Histological analysis
Time frame: 1 year
Immunohistochemistry, in situ hybridisation, electron microscopy, collagen cross-linking
Molecular analysis
Time frame: 1 year
genome sequencing, miRNA and RNA sequencing, culture, RT-PCR, flow cytometry and immunocytochemistry
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 22 Oct 2026.
- Individual participant dataSharing planned: Undecided. All data will be anonymised.
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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.
Waqas Ullah principal investigator
University Hospital Southampton NHS Foundation 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 and Fibrosis Myocardial, run by University Hospital Southampton NHS Foundation 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 2 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 22 Oct 2026. 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?
Histological analysis (time frame: 1 year). The study lists 2 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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.