Atrial Fibrillation (AF)NCT06627959
StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation
A study testing Statseal and Figure of eight suture in people with Atrial Fibrillation (AF) and Vascular Access, run by Mid and South Essex NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Vascular Access
- What is being tested?
- Statseal and Figure of eight suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 3 Jan 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients age \>18
- Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 3 femoral venous access sites
- Willing and able to give informed consent
Who cannot join
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- Platelet count \< 100,000 cells/mm3
- BMI \> 45 kg/m2 or \< 20 kg/m2
- Attempted femoral arterial access or inadvertent arterial puncture
- Procedural complications that interfered with routine recovery, ambulation, or discharge times
- Incorrect sheath placement
Show all 9Show fewer
- Intraprocedural bleeding or thrombotic complications
- Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath
- History of bleeding diathesis, coagulopathy, hypercoagulability, or thromboembolic events
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
The Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
East Sussex Healthcare NHS Trust
Eastbourne, BN21 2UD
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
About this study
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.
Read more
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.
- Conditions
- Atrial Fibrillation (AF), Vascular Access
- Being tested
- Statseal, Figure of eight suture
- Keywords
- atrial fibrillation, vascular closure, Statseal
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatsealDevice
This is a vascular closure device which works independently of the clotting cascade to seal access sites
Figure of eight sutureDevice
The figure of eight suture is commonly used for vascular access closure
| Study group | Role | What they receive |
|---|---|---|
| Statseal | Active comparator | This group shall receive the StatSeal device for vascular closure Receives: Device: Statseal |
| Figure of eight suture | Active comparator | This group shall receive the figure of eight suture (attached to a three-way stopcock) for vascular closure Receives: Device: Figure of eight suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (7)
Time to haemostasis
time elapsed between removal of the vascular sheath and first observed and confirmed venous haemostasis, for each access site
Measured: 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
Measured: 1 day
Time to discharge
time elapsed between removal of the final sheath and when the patient was discharged from the institution
Measured: 1 day
Incidence of major periprocedural adverse events
defined as adverse events until hospital discharge requiring medical intervention.
Measured: 1 day
Incidence of major adverse events
Major adverse events are defined as complications requiring medical intervention or hospitalisation
Measured: 30 days
Incidence of minor adverse events
Minor adverse events are defined as AEs not requiring medical intervention.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start3 Jan 2025
- Primary completion12 Dec 2025
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627959
- Sponsor's protocol ID
- 348992
- Status last verified
- Jan 2025
- First submitted
- 1 Oct 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation
- ClinicalTrials.gov ID
- NCT06627959
- Acronym / sponsor ID
- 348992
- Conditions
- Atrial Fibrillation (AF), Vascular Access
- Keywords
- atrial fibrillation, vascular closure, Statseal
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 4 Oct 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statseal | Active comparator | Device: StatsealThis group shall receive the StatSeal device for vascular closure |
| Figure of eight suture | Active comparator | Device: Figure of eight sutureThis group shall receive the figure of eight suture (attached to a three-way stopcock) for vascular closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients age \>18
- Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 3 femoral venous access sites
- Willing and able to give informed consent
Key exclusion criteria (9 listed)
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- Platelet count \< 100,000 cells/mm3
- BMI \> 45 kg/m2 or \< 20 kg/m2
- Attempted femoral arterial access or inadvertent arterial puncture
- Procedural complications that interfered with routine recovery, ambulation, or discharge times
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 |
|---|---|---|
| StatsealThis is a vascular closure device which works independently of the clotting cascade to seal access sites | Device | Statseal |
| Figure of eight sutureThe figure of eight suture is commonly used for vascular access closure | Device | Figure of eight suture |
Primary outcome
Time to ambulation (TTA) after sheath removal
Time frame: 1 day
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.
7 secondary outcomes
Time to haemostasis
Time frame: 1 day
Time to discharge eligibility
Time frame: 1 day
Time to discharge
Time frame: 1 day
Incidence of major periprocedural adverse events
Time frame: 1 day
Incidence of major adverse events
Time frame: 30 days
Incidence of minor adverse events
Time frame: 30 days
Comparison of EuroQol EQ-5D-5L
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Statseal and Figure of eight suture in people with Atrial Fibrillation (AF) and Vascular Access, run by Mid and South Essex NHS Foundation Trust at 3 sites 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to ambulation (TTA) after sheath removal (time frame: 1 day). 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 23 Dec 2025.