StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation
Research type
Research Study
Full title
StatSeal vs. Figure-of-Eight Suture Following Atrial Fibrillation Ablation: The StatSeal-AF Study
IRAS ID
348992
Contact name
Neil Srinivasan
Contact email
Sponsor organisation
Mid and South Essex NHS Foundations Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This study will compare two techniques used to stop bleeding after catheter ablation procedures for atrial fibrillation (AF), a common heart rhythm disorder. Catheter ablation requires access to blood vessels in the leg, and after the procedure, the access site needs to be safely closed to prevent bleeding.
The study will compare the use of a vascular closure device called StatSeal, which seals the site with a special disc, to a standard method known as the figure-of-eight suture, where a stitch is applied to close the access site. Both techniques are commonly used in practice and are considered safe.
The main goal of the study is to determine whether StatSeal allows patients to start walking sooner after their procedure compared to the figure-of-eight suture. This is important because a quicker recovery may help patients leave the hospital sooner, reducing costs and improving patient satisfaction.
We will recruit 160 patients who are undergoing AF ablation at multiple hospitals. Participants will be randomly assigned to receive either StatSeal or the figure-of-eight suture after their procedure. We will monitor their recovery, time to ambulation, and any complications that occur. Patients will also complete short questionnaires about their comfort during recovery, both before leaving the hospital and one month later.
The findings from this study could improve care for patients undergoing AF ablation by identifying the best method for closing access sites, potentially leading to quicker recovery times and fewer complications.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
24/SC/0353
Date of REC Opinion
24 Oct 2024
REC opinion
Favourable Opinion