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Not Yet Recruiting NCT07926191

Tissue Adhesive Versus Figure-of-Eight Suture for Femoral Venous Closure After Electrophysiology Procedures (GLUE-EP)

Conditions: Vascular Access Site Complication, Hematoma, Atrial Fibrillation, Arrhythmias, Cardiac

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1400
Sponsor: Nemocnice AGEL Trinec-Podlesi a.s.

Location: Nemocnice AGEL Trinec-Podlesi a.s. Třinec

Summary

In July 2026 the electrophysiology laboratory of a Czech tertiary cardiology centre introduced topical cyanoacrylate tissue adhesive (DERMABOND Mini or Histoacryl) as a routine alternative to the figure-of-eight suture for closing femoral venous puncture sites after electrophysiology procedures, including pulsed-field ablation performed through 13-17 F sheaths. After sheath removal, haemostasis is achieved by manual compression and the adhesive seals the skin over the puncture. The change was a clinical decision of the department, not a study intervention. Published experience with this approach is limited, particularly for large-bore venous sheaths. GLUE-EP evaluates the access-site safety of the practice change using routinely recorded data only. Procedures closed with tissue adhesive are compared with a historical cohort closed with a figure-of-eight suture in 2024-2025 (propensity-score matched) and with a concurrent cohort closed with a suture during the same period. A prospective continuation collects the same routine data until 30 June 2027 from patients who give written informed consent. The study assigns no treatment, adds no examination, questionnaire or study visit, and does not influence how the puncture site is closed. The primary outcome is any major or minor access-site vascular complication within 30 days of the procedure.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older * Elective electrophysiology procedure (diagnostic study or catheter ablation) with at least one femoral venous sheath * Femoral venous puncture site closed with topical cyanoacrylate tissue adhesive (Groups A and P) or with a figure-of-eight suture (Groups B and C) * Group P only: written informed consent to the use of routine medical records Exclusion Criteria: * Arterial access during the same procedure * Non-elective or emergency procedure * Groups B and C: documentation of a closure method other than a figure-of-eight suture (compression alone, vascular closure device) * Group P only: inability to understand the patient information or to give consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07926191). StuddyBuddy aggregates publicly available trial information.