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

Mid and South Essex NHS Foundation Trust

Status: Active, not recruiting

Conditions: Vascular Access; Atrial Fibrillation (AF)

Treatments: Device: Figure of eight suture; Device: Statseal

Study type: Interventional

Funder types: Other

Identifiers

NCT06627959

348992

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Statseal

Active Comparator group

Description:

This group shall receive the StatSeal device for vascular closure

Treatment:

Device: Statseal

Figure of eight suture

Active Comparator group

Description:

This group shall receive the figure of eight suture (attached to a three-way stopcock) for vascular closure

Treatment:

Device: Figure of eight suture