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

NCT06627959 | Active Not Recruiting DMC

• 1 other identifier: 348992
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

atrial fibrillation; vascular closure; Statseal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time to haemostasis

  1 day

• Time to discharge eligibility

  1 day

• Time to discharge

  1 day

• Incidence of major periprocedural adverse events

  1 day

• Incidence of major adverse events

  30 days

Study Arms (2)

Statseal

ACTIVE COMPARATOR

This group shall receive the StatSeal device for vascular closure

Device: Statseal

Figure of eight suture

ACTIVE COMPARATOR

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

Device: Figure of eight suture

Interventions

Statseal DEVICE

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

Statseal

Figure of eight suture DEVICE

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

Figure of eight suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead

Study Sites (3)

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

East Sussex Healthcare NHS Trust

Eastbourne, BN21 2UD, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 4, 2024
• Study Start: January 3, 2025
• Primary Completion: December 12, 2025
• Study Completion: January 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)