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

Launched by MEDINICE S.A. · Mar 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called PacePress, which is designed to help prevent bleeding complications in patients undergoing procedures to implant devices that help manage heart conditions, such as pacemakers and defibrillators. The PacePress device works by applying a steady and adjustable pressure to the area where the device is placed, which can help reduce the risk of bleeding and related issues, like hematomas (which are collections of blood outside of blood vessels).

To participate in this trial, individuals need to be over 18 years old and qualify for certain heart device procedures, especially if they are at a higher risk for bleeding due to their medical history or medications they are taking. Participants in the trial can expect to receive care using the PacePress device during their procedure, and the study aims to gather information on how well it performs in preventing complications. It's important to note that certain people, such as those with specific health conditions or who are pregnant, may not be eligible to join the trial.

Gender

ALL

Eligibility 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.