Tissue Adhesive Versus Figure-of-Eight Suture for Femoral Venous Closure After Electrophysiology Procedures (GLUE-EP)
NCT07926191, Not yet recruiting, Nemocnice AGEL Trinec-Podlesi a.s.
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Tissue Adhesive Versus Figure-of-Eight Suture for Femoral Venous Closure After Electrophysiology Procedures (GLUE-EP) | ClinicalTrials.gov |
| NCT number | NCT07926191 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 1,400 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Nemocnice AGEL Trinec-Podlesi a.s. | ClinicalTrials.gov |
| Conditions | Vascular Access Site Complication, Hematoma, Atrial Fibrillation, Arrhythmias, Cardiac | ClinicalTrials.gov |
| Interventions | Topical cyanoacrylate tissue adhesive, Figure-of-eight suture | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Participants With Access-Site Vascular Complications | From the procedure through 30 days after the procedure | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants Requiring Conversion From Tissue Adhesive to Figure-of-Eight Suture | During the index procedure (day 0) | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants Discharged on the Day of the Procedure | Day 0 (day of the procedure) | Discharge from hospital on the calendar day of the index procedure, as recorded in the departmental registry. | ClinicalTrials.gov |
| Secondary | Length of Post-Procedural Hospital Stay | From the procedure to hospital discharge, assessed up to 30 days | Number of nights spent in hospital after the index procedure, taken from the discharge summary. | ClinicalTrials.gov |
| Secondary | Number of Participants With Unplanned Healthcare Contact Related to the Access Site | From discharge through 30 days after the procedure | Any unplanned outpatient visit, emergency department visit, readmission or telephone contact related to the femoral access site, as recorded in the hospital information system. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)