Comparing StatSeal and Figure-of-Eight Suture for Closing Vascular Access after AF Ablation
StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation
This study tests whether using a special device called StatSeal for closing blood vessels after heart surgery helps people recover and move around faster than the traditional stitching method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mid and South Essex NHS Foundation Trust Academic / other |
| Locations | 1 site (Basildon, Essex) |
| Trial ID | NCT06627959 on ClinicalTrials.gov |
What this trial studies
This study compares two methods of vascular closure following catheter ablation for atrial fibrillation (AF). It aims to determine if the StatSeal device, a haemostatic disc, allows for quicker recovery and ambulation compared to the traditional figure-of-eight suture technique. Participants will be randomly assigned to receive either closure method after their procedure, and various outcomes such as time to ambulation, complete haemostasis, and patient comfort will be evaluated. The study will involve 160 participants undergoing elective AF ablation.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing elective catheter ablation for atrial fibrillation.
Not a fit: Patients with active infections, severe obesity, or a history of bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster recovery times and improved patient comfort after AF ablation procedures.
How similar studies have performed: Other studies have shown varying success with different vascular closure techniques, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basildon, Essex
- The Essex Cardiothoracic Centre — Basildon, Essex, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Neil Srinivasan, MBBS
- Email: neil.srinivasan2@nhs.net
- Phone: +4401268 524900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.