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New compression device aims to stop bleeding in heart implant patients

NCT ID NCT05292326

Prevention Sponsor: Medinice S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a medical device called PacePress in 122 patients at high risk of bleeding who were getting a heart device implant. The device uses controlled compression to prevent hematomas and other bleeding complications. The trial was terminated early, so its effectiveness is not fully known.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PacePress device (electronically-controlled compression site)
What this could lead to
If it works, this could offer a safer way to prevent bleeding and hematomas after heart device implantation, reducing hospital stays and complications.
What could go wrong
The trial was terminated early, so results are limited. It is a small, early-stage study, and the device may not prove better than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

122 people

The number who actually took part.

Started

May 2021

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age \> 18 years. 2. The patient qualified for: * the CIED implantation procedure (initial), * the CIED replacement procedure (ICD, CRT), * expansion of the system, * revision of electrodes. 3. The patient standing high bleeding risk defined as a result of PACE DRAP ≥5. 4. The patient taking anti-coagulation or anti-platelet drugs or anti-coagulation and anti-platelet drugs permanently. Exclusion Criteria: 1. The absence of written consent to participate in the study. 2. A female patient who is pregnant or breast-feeds. 3. The interview reveals addiction to alcohol, drugs, and other psychoactive substances. 4. The anamnesis reveals known hemorrhagic diathesis or thrombocytopenia, particularly after heparin is administered. 5. Active infection of the implantation site. 6. Active infection 4 weeks before inclusion in the study. 7. Anomaly in the chest near the device site. 8. The patient participates in another clinical trial. 9. Anticipated life span \< 6 months. 10. Diagnosed allergy to any device ingredient. 11. The patient undergoes active biological therapy. 12. Treated cancer. 13. The patient undergoes shoulder girdle physiotherapy. 14. The patient undergoes systemic steroid therapy (intravenous therapy). 15. Obesity preventing the application of PacePress device. Criteria excluding the patient from the study that may appear during or immediately after the procedure: 16. Cardiac arrest (CPR) 17. Perforation. 18. Pneumothorax. 19. Intubation (patient intubated after the procedure). 20. Change of pacemaker position (conversion to the right side). 21. Procedure completed without implantation of the intended system. 22. Need for invasive treatment of complications of the procedure.

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Conditions

The condition(s) this trial relates to.

Hematoma Hemorrhage Pathologic Processes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematoma Hemorrhage Hemorrhagic complications Pathologic processes

Contacts and locations

Locations

  • Cardiology Clinic, Medical University of Warsaw

    Warsaw, 02-091, Poland

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

    Warsaw, 02-507, Poland

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

    Zabrze, 41-800, Poland

  • Electrocardiology Clinic, Medical University

    Lodz, Łódź Voivodeship, 92-213, Poland

  • I Cardiology Clinic, Medical University in Poznań

    Poznan, 61-848, Poland

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

    Warsaw, Poland

  • Wolski Hospital, Cardiology Ward

    Warsaw, 01-211, Poland

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