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

Hemorrhage Clinical Trial

Official title: Assessment of Safety and Efficiency of the Medical Device Called PacePress to Prevent Hemorrhagic Complications in Patients With High Bleeding Risk Undergoing CIED Implantation Procedures in an Open-label, Multi-Centre Clinical Trial.

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The study will be an open-label, multi-center, monitored randomized study with 130 subjects qualified for CIED implantation procedure in specialized facilities. The study consists in randomizing patients to be treated using PacePress medical device following the CIED implantation procedure for a randomly-selected group of patients or for a standard treatment to compare safety and efficiency of PacePress and standard treatment with respect to preventing hemorrhagic complications and implantation site inflammation. 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 studied medical device is PacePress (Medinice S.A.). This is an electronically-controlled compression site 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 130 patients aged above 18 years. The study subjects will be divided into groups at random:

GROUP A - Following the procedure, the patients will be dressed with a PacePress medical device instead of a standard compression device.

The planned number of group members: n= 65 people GROUP B - Following the procedure, the patients will be dressed with a standard compression device.

The planned number of group members: n= 65 people Any female patients of child-bearing age will undergo a pregnancy test. The patient will be requested to assess pain intensity based on the analogue VAS of the area where the procedure will be carried out. During the eligibility visit, the investigator will assess also the patient's bleeding risk based on the PACE DRAP scale, and enumerate the anti-coagulation, anti-platelet, and painkilling medication taken by the patient. Selected complete blood count parameters and CRP, creatinine, eGFR, APPT, and also INR in VKA patients, will be examined before the procedure. The investigator will interview the patient with respect to any concomitant diseases. The quality of life survey will be also be carried out during the eligibility visit with the patient.

Following the initial CIED implantation procedure or the system expansion procedure with no revision of existing electrodes, with no cardiac arrest (CPR) and not resulting in any perforation, emphysema, intubation (the patient intubated after the procedure), and with no need to replace the pacemaker (conversion to the right-hand side) or the procedure is not finished without implanting the intended/planned system during the procedure, the patients will be included in one of two groups at random:

• GROUP A - Following the procedure, the patients will be dressed with a PacePress medical device instead of a standard compression device.

• GROUP B - Following the procedure, the patients will be dressed with a standard compression device used in study facilities.

VKA patients will have their INR level verified. The first assessment will take place 24-48 h after the procedure in both groups. During it, the dressing will be replaced, blood pressure measured, the macroscopic assessment of the implantation site will be carried out by the Investigator before discharging the patient from the hospital. VKA patients will have their INR level verified.

All patients will have their implantation site examined by USG. 7 (-0/+2) days after the procedures all the patients will undergo the second follow-up visit when they will have their blood pressure measured, the macroscopic assessment carried out by the Investigator, the follow-up USG examination of the implantation site carried out and selected parameters of the complete blood count and CRP, creatinine, eGFR, APTT examined. The patient will be requested to assess pain intensity based on the analogue VAS. During this visit, the patient will be requested also to fill in an anonymous usability validation form in the investigator's presence.

The last follow-up visit will take place 30 (+/-5) days after the procedure, with blood pressure measured, macroscopic assessment of the implantation site carried out, selected parameters of the complete blood count and CRP, creatinine, eGFR, and APTT, examined and a follow-up USG examination of the site carried out. The patient will be requested to assess pain intensity based on the analogue VAS, and the quality-of-life survey SF-36 will be completed by the patient.

In the study, the assumptions were made concerning the gradation of hematoma occurrence in particular groups and an equal proportion of patients (1:1 randomization). Assuming the first-type error α=0.05 for the two-sided hypothesis and the test power of 0.8, 116 patients should be included in the study (58 patients in each group). Assuming the drop-out rate of 10%, the required sample size should be increased to 130 patients (65 patients in each group). ;

Related Conditions & MeSH terms

• Hematoma
• Hemorrhage
• Hemorrhagic Complications
• Pathologic Processes

• NCT number: NCT05292326
• Study type: Interventional
• Source: Medinice S.A.
• Contact: Przemyslaw Mitkowski, Prof. MD PhD
• Phone: +48 61.8549326
• Email: przemyslaw.mitkowski@skpp.edu.pl
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2021
• Completion date: August 31, 2023