| Sumario: | Background: While 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. Methods: The 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. Results: Two 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. Conclusion: The use of VCD resulted in significant reductions in TTA, TTH, and TTDE, with no major or minor complications and a high success rate. Summary: What is known:Manual compression (MC) remains the standard of care to achieve hemostasis following catheter ablation for atrial fibrillation at many hospitals.There is a growing need to achieve efficient, safe, and effective post‐procedure venous hemostasis in order to improve the post‐procedure recovery process to reduce vascular access complications, reduce patient discomfort, and shorten the recovery period to facilitate same‐day discharge.What the study adds:The ReliaSeal trial was a prospective, randomized controlled trial comparing vascular closure devices (VCD) to manual compression (MC) in patients undergoing catheter‐based procedures requiring single or multiple access sites utilizing up to 12F sheaths.Compared to subjects receiving MC, there was a shorter time to ambulation (TTA), time to hemostasis (TTH), and time to discharge eligibility (TTDE) in subjects receiving VCD.VCD use was associated with a high success rate with no major or minor complications.
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