Clinical trial NCT06627959: StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation
Official title: StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Vascular Access
Keywords: atrial fibrillation
vascular closure
Statseal
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Male and female patients age \&gt;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 \&lt; 100,000 cells/mm3
* BMI \&gt; 45 kg/m2 or \&lt; 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

Primary outcomes:
measure: Time to ambulation (TTA) after sheath removal
timeFrame: 1 day
Secondary outcomes:
measure: Time to haemostasis
timeFrame: 1 day
measure: Time to discharge eligibility
timeFrame: 1 day
measure: Time to discharge
timeFrame: 1 day
measure: Incidence of major periprocedural adverse events
timeFrame: 1 day
measure: Incidence of major adverse events
timeFrame: 30 days
measure: Incidence of minor adverse events
timeFrame: 30 days
measure: Comparison of EuroQol EQ-5D-5L
timeFrame: 30 days
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: The Essex Cardiothoracic Centre
state: Essex
Study officials:
References: