An observational study in Vascular Access Site Complication, Hematoma and Atrial Fibrillation, sponsored by Nemocnice AGEL Trinec-Podlesi a.s.. Not yet recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Nemocnice AGEL Trinec-Podlesi a.s. · Observational
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.
BACKGROUND
Closure of the femoral venous puncture site is the most frequent source of complications after electrophysiology (EP) procedures. The departmental standard has been a percutaneous figure-of-eight suture, removed 2 to 6 hours after the procedure. Topical cyanoacrylate tissue adhesive is an alternative that requires no removal: after sheath removal, haemostasis is achieved by manual compression and the adhesive then seals the skin over the puncture, which is the use for which the CE-marked products are intended. With the spread of pulsed-field ablation, venous sheath size has increased to 13-17 F, so the question of closure is most pressing for large-bore access. Published experience is limited: the only comparative report identified in PubMed concerns skin adhesive combined with a vascular closure device after atrial fibrillation ablation, not adhesive used instead of a suture.
PRACTICE CHANGE
Since 1 July 2026 the EP laboratory of Nemocnice AGEL Trinec-Podlesi a.s. (Czechia) has used topical cyanoacrylate tissue adhesive (2-octyl cyanoacrylate, DERMABOND Mini; or n-butyl-2-cyanoacrylate, Histoacryl) as a standard alternative to the figure-of-eight suture. This was a clinical decision of the department, not a research intervention. By 17 September 2026, 192 procedures had been closed with adhesive (177 catheter ablations and 15 diagnostic EP studies; 127 pulsed-field ablations through 13-17 F sheaths). Adhesive was used in 40%, 73% and 72% of procedures in July, August and September 2026, respectively.
DESIGN
Single-centre observational cohort study in two parts with identical population and outcome definitions. The study does not assign the closure method; it is chosen by the treating physician.
Part R (retrospective):
Part P (prospective continuation): procedures closed with adhesive from the day after the ethics committee opinion to 30 June 2027, in patients who gave written informed consent before the procedure. Consent is sought at admission from all patients scheduled for an elective EP procedure with femoral venous access, because the closure method is decided during the procedure; only patients whose puncture site is closed with adhesive enter the analysis. The same routine variables are collected from the same sources; apart from obtaining consent, there is no additional examination, measurement, questionnaire or patient contact.
ASCERTAINMENT OF THE CLOSURE METHOD
In 2026, adhesive use is recorded in the departmental procedure registry. For Groups B and C, the closure method is taken from the procedure report and discharge summary. Because the figure-of-eight suture was the departmental standard, a procedure is classified as suture-closed unless another method is documented; procedures with another documented method (compression alone, vascular closure device) are excluded. The proportion of procedures without an explicit record of the suture is reported, and a sensitivity analysis restricts Groups B and C to procedures with an explicit record.
ASCERTAINMENT OF OUTCOMES
Access-site complications are identified from discharge summaries and from all records in the hospital information system up to day 30 after the procedure (outpatient visits, emergency department visits, readmissions, telephone contacts), not from the complication field of the departmental registry. A procedure without any record after discharge is counted as having no recorded complication; the proportion of such procedures is reported by group, and these procedures are excluded in a sensitivity analysis.
STATISTICAL ANALYSIS
Groups A and B are matched 1:1 by propensity score (nearest neighbour without replacement, caliper 0.2 SD of the logit of the score, exact matching on sheath size 5-9 F versus 13-17 F). The score is estimated by logistic regression from age, sex, procedure type, ablation system, number and size of sheaths, antithrombotic therapy and ultrasound-guided puncture; balance is checked by standardised differences (target below 0.1). The primary comparison (Group A versus matched Group B) uses the McNemar test and conditional logistic regression (odds ratio with 95% confidence interval). The comparison with Group C uses covariate-adjusted logistic regression, with inverse probability weighting as a sensitivity analysis. Binary secondary outcomes are analysed by logistic regression and length of stay (nights) by negative binomial regression. Part P is analysed descriptively and compared with Group A, with complication and conversion rates shown by calendar quarter. The large-bore (13-17 F) subgroup is pre-specified and analysed descriptively.
There is no formal sample size calculation; all eligible procedures in the defined periods are included. The study is estimation-oriented and is not designed to demonstrate non-inferiority. With 192 adhesive procedures, 0, 2 and 4 observed events correspond to upper limits of the 95% Wilson confidence interval of 2.0%, 3.7% and 5.2%, respectively.
Not collected: time to haemostasis, time to ambulation, pain scores, patient satisfaction, closure cost and operator confidence. These are not recorded in routine documentation and will not be reported.
ETHICS AND DATA PROTECTION
The protocol was submitted to the Ethics Committee of Nemocnice AGEL Trinec-Podlesi a.s. in October 2026, with a request for waiver of informed consent for Groups A, B and C; written informed consent is obtained in Part P. The analytic dataset is pseudonymised; the key is held on a secure hospital server and is accessible only to the principal investigator. Only aggregate data are reported.
DISSEMINATION
Abstract at an international cardiology congress and publication in a peer-reviewed journal regardless of the direction of the results.
109 studies on the registry are indexed under Hematoma; 19 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 113 across 21 observational studies indexed under Hematoma.
Browse Hematoma studies →Nemocnice AGEL Trinec-Podlesi a.s. is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
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Adults undergoing elective electrophysiology procedures (diagnostic EP studies and catheter ablations, including pulsed-field ablation) with femoral venous access at the electrophysiology laboratory of Nemocnice AGEL Trinec-Podlesi a.s., Czechia, identified consecutively from the departmental procedure registry within the defined periods.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Elective EP procedures with femoral venous puncture sites closed with topical cyanoacrylate tissue adhesive from 1 July 2026 to the date of the ethics committee opinion. Data from routine records; waiver of consent requested.
Device: Topical cyanoacrylate tissue adhesive
Elective EP procedures closed with a percutaneous figure-of-eight suture from 1 January 2024 to 31 December 2025; propensity-score matched 1:1 to Group A. Data from routine records; waiver of consent requested.
Procedure: Figure-of-eight suture
Elective EP procedures of the same period as Group A (from 1 July 2026 to the date of the ethics committee opinion) in which adhesive was not used and the puncture site was closed with a figure-of-eight suture. Data from routine records; waiver of consent requested.
Procedure: Figure-of-eight suture
Elective EP procedures closed with topical cyanoacrylate tissue adhesive from the day after the ethics committee opinion to 30 June 2027, in patients who gave written informed consent before the procedure. Same routine variables and sources as Group A.
Device: Topical cyanoacrylate tissue adhesive
Routine clinical practice, not assigned by the study. After sheath removal and haemostasis by manual compression, the skin over the femoral venous puncture is sealed with CE-marked topical cyanoacrylate tissue adhesive: 2-octyl cyanoacrylate (DERMABOND Mini) or n-butyl-2-cyanoacrylate (Histoacryl).
Also known as: DERMABOND Mini, Histoacryl
Routine clinical practice, not assigned by the study. Percutaneous figure-of-eight (purse-string) skin suture placed over the femoral venous puncture after sheath removal and released 2 to 6 hours later.
Number of Participants With Access-Site Vascular Complications
Any major or minor vascular complication at the femoral venous access site, using VARC-3 criteria adapted for venous access. Major: bleeding requiring transfusion or surgical or interventional revision; pseudoaneurysm or arteriovenous fistula requiring treatment; access-site infection requiring systemic antibiotics or revision; deep vein thrombosis. Minor: haematoma without transfusion or revision but with prolonged hospital stay or unplanned healthcare contact; pseudoaneurysm or fistula managed conservatively; local reaction requiring treatment. Ascertained from discharge summaries and all hospital records up to day 30. Primary comparison: Group A versus propensity-matched Group B; key secondary comparison: Group A versus Group C. Pre-specified subgroup: 13-17 F sheaths.
Time frame: From the procedure through 30 days after the procedure
Number of Participants Requiring Conversion From Tissue Adhesive to Figure-of-Eight Suture
Conversion to a figure-of-eight suture because of inadequate haemostasis immediately after sheath removal, in procedures intended for adhesive closure (Groups A and P). Ascertained from the procedure report and discharge summary.
Time frame: During the index procedure (day 0)
Number of Participants Discharged on the Day of the Procedure
Discharge from hospital on the calendar day of the index procedure, as recorded in the departmental registry.
Time frame: Day 0 (day of the procedure)
Length of Post-Procedural Hospital Stay
Number of nights spent in hospital after the index procedure, taken from the discharge summary.
Time frame: From the procedure to hospital discharge, assessed up to 30 days
Number of Participants With Unplanned Healthcare Contact Related to the Access Site
Any unplanned outpatient visit, emergency department visit, readmission or telephone contact related to the femoral access site, as recorded in the hospital information system.
Time frame: From discharge through 30 days after the procedure
Plan to share: No — Only aggregate results will be published. Individual participant data will not be shared: the retrospective part relies on a waiver of consent, and participants in the prospective part consent to the use of their pseudonymised data by the study team only.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Nemocnice AGEL Trinec-Podlesi a.s.