Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoing CIED Implantation.

Overview

PacePress medical device, by ensuring constant compression force and the ability to optimize it in the pocket area prevents/significantly reduces the risk of hemorrhagic complications, including but not limited to the operation pocket hematoma. By avoiding a strong localized compression and ensuring "covering compression" achieved by the appropriate distribution of compression forces on the entire implantation site area, with an automated compression force control, the risk of a pressure sore created in the compressed pocket area is reduced.

The study will be an open-label, multi-center, monitored randomized study with 235 subjects qualified for: * the CIED implantation procedure (initial), * the CIED replacement procedure (ICD, CRT), * expantion of the system, * revision of electrodes. The study consists in randomization of patients who meet all the inclusion criteria and do not meet any of the exclusion criteria, after performing the above procedure for the group (A): the PacePress medical device will be used, or (B): a standard of care will be used, in order to compare the safety and efficacy of the PacePress in relation to the standard of care, in preventing hemorrhagic complications and site infections. Data regarding the assessment of the safety and effectiveness of the PacePress medical device are collected on the day of the procedure and during the 30-day patient observation. In PacePress clinical trial, the standard pharmacotherapeutic procedures in the facility are not modified or affected (including but not limited to the anti-coagulation and antiplatelet treatment) according to the guidelines and standard procedure ESC and PTK in patients included in the study. The investigational medical device is the PacePress (Medinice S.A.). This is an electronically-controlled self-pressure dressing that, , thanks to a well-selected compression force, may contribute significantly to preventing hemorrhagic complications following electrotherapy procedures, including increasing the safety of CIED implantation procedures and accelerating wound healing significantly. The planned number of patients included in the study is 235 patients aged above 18 years. The study subjects will be divided into groups at random (4:1): GROUP A - Following the procedure, the patients will be dressed in the PacePress - investigational medical device instead of a standard compression device. The planned number of group members: n= 188 people. GROUP B - Following the procedure, the patients will be dressed in the standard compression device. The planned number of group members: n= 47 people. In the study, the assumptions were made concerning the gradation and frequency of hematoma occurrence in particular groups and randomization of patients (4:1). Assuming the first-type error α=0.025 for the one-sided hypothesis and the test power of 0.8, 194 patients should be included in the study. Due to the planned interim analysis, which will be performed after half of the patients have been included in the study, and assuming the drop-out rate of 8 %, the required sample size should be increased to 235 patients.