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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vascular Access; Atrial Fibrillation (AF)
• Intervention / Treatment: Device: Statseal; Device: Figure of eight suture

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Eastbourne, United Kingdom, BN21 2UD
    • East Sussex Healthcare NHS Trust
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospital
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • The Essex Cardiothoracic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Statseal; This group shall receive the StatSeal device for vascular closure	Device: Statseal; This is a vascular closure device which works independently of the clotting cascade to seal access sites
Active Comparator: Figure of eight suture; This group shall receive the figure of eight suture (attached to a three-way stopcock) for vascular closure	Device: Figure of eight suture; The figure of eight suture is commonly used for vascular access closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to haemostasis	time elapsed between removal of the vascular sheath and first observed and confirmed venous haemostasis, for each access site	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	1 day
Time to discharge	time elapsed between removal of the final sheath and when the patient was discharged from the institution	1 day
Incidence of major periprocedural adverse events	defined as adverse events until hospital discharge requiring medical intervention.	1 day
Incidence of major adverse events	Major adverse events are defined as complications requiring medical intervention or hospitalisation	30 days
Incidence of minor adverse events	Minor adverse events are defined as AEs not requiring medical intervention.	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.	30 days

Collaborators and Investigators

• Sponsor: Mid and South Essex NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Actual): December 12, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: atrial fibrillation; vascular closure; Statseal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 348992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No