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

Launched by MID AND SOUTH ESSEX NHS FOUNDATION TRUST · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to close the blood vessel after a procedure called catheter ablation, which is done to treat a heart condition known as atrial fibrillation (AF). The goal is to see if using a device called StatSeal, which is a special disc that helps stop bleeding, allows patients to recover and start walking faster compared to the traditional figure-of-eight suture method. The study will also look at how quickly bleeding stops, when patients are able to leave the hospital, and how comfortable they feel with each method.

To take part in this trial, participants need to be adults over 18 years old who are having a catheter ablation for AF and are able to provide informed consent. The study will include 160 participants, divided into two groups, with 80 receiving StatSeal and 80 receiving the suture. Throughout the trial, participants will be carefully monitored to ensure their safety. This research aims to find out which method could lead to a better recovery experience for patients.

Gender

ALL

Eligibility 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