Hemorrhagic ComplicationsPacePressNCT05292326
Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoing CIED Implantation.
A study testing PacePress and standard compression band in people with Hemorrhagic Complications and Hematoma, run by Medinice S.A. at 7 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhagic Complications, Hematoma, Hemorrhage
- What is being tested?
- PacePress and standard compression band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 7 sitesPoland
- Study dates
- 25 May 2021to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- The patient qualified for:
- the CIED implantation procedure (initial),
- the CIED replacement procedure (ICD, CRT),
- expansion of the system,
- revision of electrodes.
- The patient standing high bleeding risk defined as a result of PACE DRAP ≥5.
- The patient taking anti-coagulation or anti-platelet drugs or anti-coagulation and anti-platelet drugs permanently.
Who cannot join
- 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 4 weeks before inclusion in the study.
Show all 23Show fewer
- 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.
- Criteria excluding the patient from the study that may appear during or immediately after the procedure:
- Cardiac arrest (CPR)
- Perforation.
- Pneumothorax.
- Intubation (patient intubated after the procedure).
- Change of pacemaker position (conversion to the right side).
- Procedure completed without implantation of the intended system.
- Need for invasive treatment of complications of the procedure.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Poland7 sites
Electrocardiology Clinic, Medical University
Lodz, Łódź Voivodeship, 92-213
I Cardiology Clinic, Medical University in Poznań
Poznan, 61-848
Wolski Hospital, Cardiology Ward
Warsaw, 01-211
Cardiology Clinic, Medical University of Warsaw
Warsaw, 02-091
Clinical Department of Cardiology, the National Medical Institute of the Ministry of the Interior and Administration
Warsaw, 02-507
I Clinic for Cardiac Arrhythmias National Institute of Cardiology Stefan Cardinal Wyszyński National Research Institute
Warsaw
Department of Cardiology / 1st Department of Cardiology and Angiology, Silesian Centre for Heart Diseases
Zabrze, 41-800
About this study
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.
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.
Read the detailed description
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.
- Conditions
- Hemorrhagic Complications, Hematoma, Hemorrhage, Pathologic Processes
- Being tested
- PacePress, standard compression band
- Keywords
- CIED Implantation, Hemorrhagic Complications, hematoma, pocket hematoma, bleeding risk score, cardiac implantable electronic device
- Medical subject headings
- Hematoma, Hemorrhage, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacePressDevice
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
standard compression bandDevice
standard used compression band/sand bag
| Study group | Role | What they receive |
|---|---|---|
| PacePress | Experimental | the patients will be dressed with PacePress medical device instead of a standard compression device Receives: Device: PacePress |
| standard compression band/tourniquet | Active comparator | standard treatment with respect to preventing hemorrhagic complications and implantation site inflammation, the patients will be dressed with a standard compression device/sand bag Receives: Device: standard compression band |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 (-0/+2) days after the procedure
Secondary outcomes (5)
Emergence of a hematoma
requiring a revision
Measured: based on 24-48 hour and 30 (+/- 5) day observation
Emergence of a hematoma
requiring longer hospital stay
Measured: 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
Measured: based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation
Mortality rate
number of deaths
Measured: 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
Measured: based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start25 May 2021
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Why it stopped: The study was stopped at interim analysis due to significantly better outcomes with PacePress, consistent with the predefined statistical methodology.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinice S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Przemysław Mitkowski, Prof. MD PhD, Principal investigator, Medical University in Poznań
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292326
- Sponsor's protocol ID
- PacePress_2020_03
- Acronym
- PacePress
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05292326
- Acronym / sponsor ID
- PacePress / PacePress_2020_03
- Conditions
- Hemorrhagic Complications, Hematoma, Hemorrhage, Pathologic Processes
- Keywords
- CIED Implantation, Hemorrhagic Complications, hematoma, pocket hematoma, bleeding risk score, cardiac implantable electronic device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped at interim analysis due to significantly better outcomes with PacePress, consistent with the predefined statistical methodology.
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Medinice S.A.Industry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PacePress | Experimental | Device: PacePressthe patients will be dressed with PacePress medical device instead of a standard compression device |
| standard compression band/tourniquet | Active comparator | Device: standard compression bandstandard treatment with respect to preventing hemorrhagic complications and implantation site inflammation, the patients will be dressed with a standard compression device/sand bag |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years.
- The patient qualified for:
- The patient standing high bleeding risk defined as a result of PACE DRAP ≥5.
- The patient taking anti-coagulation or anti-platelet drugs or anti-coagulation and anti-platelet drugs permanently.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PacePressan 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 | Device | PacePress |
| standard compression bandstandard used compression band/sand bag | Device | standard compression band/tourniquet |
Primary outcome
Assessment of hematoma presence
Time frame: 7 (-0/+2) days after the procedure
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.
5 secondary outcomes
Emergence of a hematoma
Time frame: based on 24-48 hour and 30 (+/- 5) day observation
Emergence of a hematoma
Time frame: based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation
Number of patients who need blood derivative transfusion
Time frame: based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation
Mortality rate
Time frame: based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation
Infection
Time frame: based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation
Results and safety
The study was stopped early (reason given: The study was stopped at interim analysis due to significantly better outcomes with PacePress, consistent with the predefined statistical methodology.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Przemysław Mitkowski, Prof. MD PhD principal investigator
Medical University in Poznań
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PacePress and standard compression band in people with Hemorrhagic Complications and Hematoma, run by Medinice S.A. at 7 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped at interim analysis due to significantly better outcomes with PacePress, consistent with the predefined statistical methodology.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of hematoma presence (time frame: 7 (-0/+2) days after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.