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

NCT ID: NCT06627959

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-03

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation (AF) Vascular Access

Keywords

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atrial fibrillation vascular closure Statseal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Statseal

This group shall receive the StatSeal device for vascular closure

Group Type ACTIVE_COMPARATOR

Statseal

Intervention Type DEVICE

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

Figure of eight suture

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

Group Type ACTIVE_COMPARATOR

Figure of eight suture

Intervention Type DEVICE

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

Interventions

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Statseal

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

Intervention Type DEVICE

Figure of eight suture

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mid and South Essex NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Essex Cardiothoracic Centre

Basildon, Essex, United Kingdom

Site Status

East Sussex Healthcare NHS Trust

Eastbourne, , United Kingdom

Site Status

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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348992

Identifier Type: -

Identifier Source: org_study_id