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NCT Number: NCT06627959

StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Access

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Essex Cardiothoracic Centre, Basildon, Essex, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Statseal

Device

This is a vascular closure device which works independently of the clotting cascade to seal access sites

Figure of eight suture

Device

The figure of eight suture is commonly used for vascular access closure

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to haemostasis

    Time frame: 1 day

    time elapsed between removal of the vascular sheath and first observed and confirmed venous haemostasis, for each access site

  2. Time to discharge eligibility

    Time frame: 1 day

    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

  3. Time to discharge

    Time frame: 1 day

    time elapsed between removal of the final sheath and when the patient was discharged from the institution

  4. Incidence of major periprocedural adverse events

    Time frame: 1 day

    defined as adverse events until hospital discharge requiring medical intervention.

  5. Incidence of major adverse events

    Time frame: 30 days

    Major adverse events are defined as complications requiring medical intervention or hospitalisation

  6. Incidence of minor adverse events

    Time frame: 30 days

    Minor adverse events are defined as AEs not requiring medical intervention.

  7. Comparison of EuroQol EQ-5D-5L

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Mid and South Essex NHS Foundation Trust

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 4, 2024
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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