NCT06627959

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Mid and South Essex NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Atrial Fibrillation (AF)
• Vascular Access

Interventions

Type	Name	Description
DEVICE	Statseal	This is a vascular closure device which works independently of the clotting cascade to seal access sites
DEVICE	Figure of eight suture	The figure of eight suture is commonly used for vascular access closure

Timeline

• Start date: 2025-01-03
• Primary completion: 2025-12-12
• Completion: 2026-01-01
• First posted: 2024-10-04
• Last updated: 2025-12-23

Locations

3 sites across 1 country: United Kingdom