Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoin… (NCT05292326) | Clinical Trial Compass
TerminatedNot Applicable
Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoing CIED Implantation.
Stopped: The study was stopped at interim analysis due to significantly better outcomes with PacePress, consistent with the predefined statistical methodology.
Poland122 participantsStarted 2021-05-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.