NCT06627959Active, not recruiting
StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 1 Oct 2024
- Start date
- 3 Jan 2025
- Primary completion date
- 12 Dec 2025
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Diseases
- Atrial fibrillation
- NCT number
- NCT06627959
What you commit to
- Study type: Interventional
- Participants enrolled: 160
- From 3 Jan 2025 to the primary completion date, 12 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- Intraprocedural bleeding or thrombotic complications
- History of bleeding diathesis, coagulopathy, hypercoagulability, or thromboembolic events
Lab values
- Platelet count \< 100,000 cells/mm3
Other
- 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
- Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Essex Cardiothoracic Centre Coordinator of this site? Confirm its status | Basildon | United Kingdom | Unknown status |
| East Sussex Healthcare NHS Trust Coordinator of this site? Confirm its status | Eastbourne | United Kingdom | Unknown status |
| Norfolk and Norwich University Hospital Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.