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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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.

Conditions
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Hematoma, Hemorrhagic Complications, Hemorrhage, Pathologic Processes

Intervention / Treatment
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* Device: PacePress
* Device: standard compression band


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years The patient qualified for the initial CIED implantation procedure, the system expansion procedure or revision of the existing electrodes. The patient standing high bleeding risk defined as a result of PACE DRAP ≥6 The patient taking anti-coagulation or anti-platelet drugs or anti-coagulation and anti-platelet drugs permanently Exclusion Criteria: The absence of written consent to participate in the study A female patient who is pregnant or breast-feeds The interview reveals addiction to alcohol, drugs, and other psychoactive substances The anamnesis reveals known hemorrhagic diathesis or thrombocytopenia, particularly after heparin is administered Active infection of the implantation site Active infection 6 months before inclusion in the study Anomaly in the chest near the device site The patient participates in another clinical trial Anticipated life span < 6 months Diagnosed allergy to any device ingredient The patient undergoes active biological therapy Treated cancer The patient undergoes shoulder girdle physiotherapy The patient undergoes systemic steroid therapy (intravenous therapy) Obesity preventing the application of PacePress device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PacePress<br>the patients will be dressed with PacePress medical device instead of a standard compression device | Device: PacePress<br>* an electronically-controlled compression site which, thanks to a well-selected compression force, may contribute significantly to preventing hemorrhagic complications following electrotherapy procedures, including to increasing safety of CIED implantation procedures and accelerate wound healing significantly<br>|
| Active Comparator: standard compression band/tourniquet<br>standard treatment with respect to preventing hemorrhagic complications and implantation site inflammation, the patients will be dressed with a standard compression device/sand bag | Device: standard compression band<br>* standard used compression band/sand bag<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of hematoma presence | according to the classification: Degree 0 - No hematoma Degree 1 - Hematoma not visible clinically - petechia above the device site (a tiny exudate or extravasation near the device, not causing any skin raising visible in a macroscopic scale), Degree 2 - Hematoma visible clinically - a visible macroscopically and palpable swelling of CIED area clearly exceeding the device dimensions, causing the tenderness and painfulness of the affected area; petechia going beyond the pocket, fluctuation symptom, small skin tension, small skin raising, Degree 3 - Hematoma significant clinically - much exceeding the device dimensions, causing significant skin tension and raising, requiring evacuation or extending hospital stay by at least 24 hours; pocket pain, significant skin raising. | 7 (-0/+2) days after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence of a hematoma | requiring a revision | based on 24-48 hour and 30 (+/- 5) day observation | 
| Emergence of a hematoma | requiring longer hospital stay | based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation | 
| Number of patients who need blood derivative transfusion | blood derivative transfusion need | based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation | 
| Mortality rate | number of deaths | based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation | 
| Infection | assessment of the wound left by the device implantation, considering any swelling of tissues around the device, fluctuation, redness, pain, excessive temperature, the outflow of any fluid from the pocket, CRP examination, WBC in the complete blood count | based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIED Implantation, Hemorrhagic Complications, hematoma, pocket hematoma, bleeding risk score, cardiac implantable electronic device