Using PacePress to prevent bleeding complications during heart device implantation
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.
This study is testing if the PacePress device can help prevent bleeding during heart device surgeries for people getting new or replacement heart implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 235 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medinice S.A. Industry-sponsored |
| Locations | 7 sites (Poznań and 6 other locations) |
| Trial ID | NCT05292326 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the PacePress medical device in preventing hemorrhagic complications during cardiac implantable electronic device (CIED) procedures. It is an open-label, multi-center, randomized study involving 235 participants who are either undergoing initial implantation or replacement of CIEDs. Participants will be randomly assigned to receive either the PacePress device or standard compression bandages, with data collected on safety and efficacy over a 30-day observation period. The study aims to optimize compression force to reduce the risk of bleeding and pressure sores at the implantation site.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are at high risk of bleeding and are scheduled for CIED implantation or replacement.
Not a fit: Patients with known bleeding disorders, active infections, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of hemorrhagic complications for patients undergoing CIED procedures.
How similar studies have performed: While similar approaches have been explored, the specific use of the PacePress device in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Poznań and 6 other locations
- I Cardiology Clinic, Medical University in Poznań — Poznań, Poland (Recruiting)
- Wolski Hospital, Cardiology Ward — Warsaw, Poland (Terminated)
- Cardiology Clinic, Medical University of Warsaw — Warsaw, Poland (Recruiting)
- Clinical Department of Cardiology, the National Medical Institute of the Ministry of the Interior and Administration — Warsaw, Poland (Recruiting)
- I Clinic for Cardiac Arrhythmias National Institute of Cardiology Stefan Cardinal Wyszyński National Research Institute — Warsaw, Poland (Terminated)
- Department of Cardiology / 1st Department of Cardiology and Angiology, Silesian Centre for Heart Diseases — Zabrze, Poland (Recruiting)
- Electrocardiology Clinic, Medical University — Łódź, Poland (Recruiting)
Study contacts
- Principal investigator: Przemysław Mitkowski, Prof. MD PhD — Medical University in Poznań
- Study coordinator: Przemysław Mitkowski, Prof. MD PhD
- Email: przemyslaw.mitkowski@usk.poznan.pl
- Phone: 48+618549326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.