Trial reportJournal of cardiovascular electrophysiology2025
Safety and Efficacy of a Novel Sealant-Based Vascular Closure Device Following Electrophysiology Procedures: ReliaSeal Trial.
Trial report in Journal of cardiovascular electrophysiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05554471 (A Multicenter, Prospective, Randomized, Controlled, Open Label Trial to Evaluate the Safety and Efficacy of Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression in Patients Who Have Undergone Endovascular Procedures Utilizing up to 12F Procedural Sheaths), which is not on this map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Prospective, Randomized, Controlled, Open Label Trial to Evaluate the Safety and Efficacy of Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression in Patients Who Have Undergone Endovascular Procedures Utilizing up to 12F Procedural Sheaths
Who cites it
3 citing papers in PubMed.
- Vascular closure devices in electrophysiology procedures: Systematic review and meta-analysis.Heart rhythm O2 · 2026Article
- Efficacy and Safety of Venous Closure Devices for Femoral Venous Access in Interventional Cardiology: A Systematic Review and Meta-Analysis.Journal of personalized medicine · 2026Review
- Clinical Efficacy of Vascular Sealant in Promoting Rapid Recovery After Total Thyroidectomy for Thyroid Cancer.Cureus · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
backgroundWhile manual compression (MC) remains the standard of care to achieve hemostasis, a novel vascular closure device (VCD) was designed to achieve faster hemostasis without compromising safety. The objective of the ReliaSeal trial was to evaluate the safety and effectiveness of the Mynx Control Venous VCD to close a single or multiple femoral venous access sites in one or both limbs in patients undergoing catheter-based procedures.
methodsThe ReliaSeal trial was a prospective, randomized controlled trial comparing VCD to MC in patients undergoing catheter-based procedures requiring single or multiple access sites utilizing up to 12F sheaths. Endpoints included time to ambulation (TTA), time to hemostasis (TTH), time to discharge eligibility (TTDE), procedural/device success, and 30-day major and minor access site complications.
resultsTwo hundred and seventy subjects were randomized to the VCD or MC arm (n = 177 vs. n = 93) with a mean age of 66.7 ± 11.27 years. TTA, TTH, and TTDE were significantly reduced in VCD subjects compared to MC (TTA: 2.6 ± 1.03 vs. 5.1 ± 4.35 h, p < 0.001; TTH: 2.1 ± 1.79 vs. 11.4 ± 7.19 min, p < 0.001; TTDE: 3.1 ± 1.24 vs. 5.5 ± 4.58 h, p < 0.001, respectively). Procedural and device success was achieved in 100% of VCD subjects, compared to 98.9% of the MC group. No major or minor complications occurred in the VCD group; with a 5% minor complication rate in the MC group.
conclusionThe use of VCD resulted in significant reductions in TTA, TTH, and TTDE, with no major or minor complications and a high success rate.
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