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

NCT05292326 | Terminated

• 1 other identifier: PacePress_2020_03
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Hemorrhagic Complications; Hematoma; Hemorrhage; Pathologic Processes

Keywords

CIED Implantation; Hemorrhagic Complications; hematoma; pocket hematoma; bleeding risk score; cardiac implantable electronic device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Emergence of a hematoma

  based on 24-48 hour and 30 (+/- 5) day observation

• Emergence of a hematoma

  based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation

• Number of patients who need blood derivative transfusion

  based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation

• Mortality rate

  based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation

• Infection

  based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation

Study Arms (2)

PacePress

EXPERIMENTAL

the patients will be dressed with PacePress medical device instead of a standard compression device

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

Device: standard compression band

Interventions

PacePress DEVICE

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

PacePress

standard compression band DEVICE

standard used compression band/sand bag

standard compression band/tourniquet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Medinice S.A.: lead

Study Sites (7)

I Cardiology Clinic, Medical University in Poznań

Poznan, 61-848, Poland

Location

Wolski Hospital, Cardiology Ward

Warsaw, 01-211, Poland

Location

Cardiology Clinic, Medical University of Warsaw

Warsaw, 02-091, Poland

Location

Clinical Department of Cardiology, the National Medical Institute of the Ministry of the Interior and Administration

Warsaw, 02-507, Poland

Location

I Clinic for Cardiac Arrhythmias National Institute of Cardiology Stefan Cardinal Wyszyński National Research Institute

Warsaw, Poland

Location

Department of Cardiology / 1st Department of Cardiology and Angiology, Silesian Centre for Heart Diseases

Zabrze, 41-800, Poland

Location

Electrocardiology Clinic, Medical University

Lodz, Łódź Voivodeship, 92-213, Poland

Location

MeSH Terms

Conditions

Hematoma; Hemorrhage; Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Przemysław Mitkowski, Prof. MD PhD

  Medical University in Poznań

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: March 23, 2022
• Study Start: May 25, 2021
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (7)