An interventional study of Statseal and Figure of eight suture in Atrial Fibrillation (AF) and Vascular Access, sponsored by Mid and South Essex NHS Foundation Trust. Active, not recruiting at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Mid and South Essex NHS Foundation Trust · Not applicable, Interventional, and Treatment
This study, titled aims to compare two vascular closure techniques after catheter ablation for atrial fibrillation (AF). Catheter ablation is a common procedure used to treat AF, but after the procedure, It is important to close the access site in the blood vessel to prevent bleeding. This study will evaluate whether the StatSeal device, a haemostatic disc, can help patients recover more quickly compared to the traditional figure-of-eight suture technique.
The primary objective of the study is to determine whether StatSeal reduces the time it takes for patients to start walking after the procedure (known as Time to Ambulation). Secondary objectives include comparing the time to complete haemostasis, discharge eligibility, incidence of adverse events, and patient comfort between the two techniques.
Participants in the study will be randomly assigned to receive either the StatSeal device or the figure-of-eight suture after their AF ablation procedure. The study will recruit 160 participants across multiple hospital sites, with 80 participants in each group. Both techniques are standard methods, and participants will be closely monitored for safety throughout the study.
By comparing these two closure techniques, the study aims to improve the recovery process for patients undergoing AF ablation and provide evidence on which method leads to better outcomes and patient experiences.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 160 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Mid and South Essex NHS Foundation Trust is the lead sponsor of 34 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group shall receive the StatSeal device for vascular closure
Device: Statseal
This group shall receive the figure of eight suture (attached to a three-way stopcock) for vascular closure
Device: Figure of eight suture
This is a vascular closure device which works independently of the clotting cascade to seal access sites
The figure of eight suture is commonly used for vascular access closure
Time to ambulation (TTA) after sheath removal
Time to ambulation is defined as the elapsed time between removal of the final sheath and the moment when the patient can stand and walk 20 feet without evidence of venous re-bleeding from the femoral access site.
Time frame: 1 day
Time to haemostasis
time elapsed between removal of the vascular sheath and first observed and confirmed venous haemostasis, for each access site
Time frame: 1 day
Time to discharge eligibility
time elapsed between removal of the final sheath and when the patient is eligible for hospital discharge based solely on the assessment of the access site, as determined by the medical team
Time frame: 1 day
Time to discharge
time elapsed between removal of the final sheath and when the patient was discharged from the institution
Time frame: 1 day
Incidence of major periprocedural adverse events
defined as adverse events until hospital discharge requiring medical intervention.
Time frame: 1 day
Incidence of major adverse events
Major adverse events are defined as complications requiring medical intervention or hospitalisation
Time frame: 30 days
Incidence of minor adverse events
Minor adverse events are defined as AEs not requiring medical intervention.
Time frame: 30 days
Comparison of EuroQol EQ-5D-5L
Comparison of EuroQol 5-level EQ-5D score. The score is made up of two parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS). The first part covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension offers five response options (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which an EQ-5D index score is calculated, ranging from 0 (death) to 1 (perfect health). The EQ-VAS assesses an individual's self-perceived health for the day on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health), where participants mark their current health status.
Time frame: 30 days
Plan to share: No
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This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Mid and South Essex NHS Foundation Trust