- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05743829
Atrial Fibrillation Driver Study
Atrial Fibrillation Driver Study - Pilot Project
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Waqas Ullah, PhD
- Phone Number: 07941461222
- Email: waqas@doctors.org.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient unable or unwilling to consent
- Patient not having ostial pulmonary vein or left atrial appendage tissue excised as part of routine clinical care.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cardiac Surgery
Patients undergoing cardiac surgery - left atrial appendage excision
|
Tissue excision
|
Thoracic Surgery
Patients undergoing lung resection - ostial pulmonary vein tissue
|
Tissue excision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histological analysis
Time Frame: 1 year
|
Immunohistochemistry, in situ hybridisation, electron microscopy, collagen cross-linking
|
1 year
|
Molecular analysis
Time Frame: 1 year
|
genome sequencing, miRNA and RNA sequencing, culture, RT-PCR, flow cytometry and immunocytochemistry
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Waqas Ullah, University Hospital Southampton NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHM CAR0630
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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