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Status:

TERMINATED

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

Lead Sponsor:

Medinice S.A.

Conditions:

Hemorrhagic Complications

Hematoma

Eligibility:

All Genders

18+ years

Phase:

NA

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 n...

Detailed Description

The study will be an open-label, multi-center, monitored randomized study with 235 subjects qualified for: * the CIED implantation procedure (initial), * the CIED replacement procedure (ICD, CRT), * ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.
  • 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:
  • Cardiac arrest (CPR)
  • Perforation.
  • Pneumothorax.
  • Intubation (patient intubated after the procedure).
  • Change of pacemaker position (conversion to the right side).
  • Procedure completed without implantation of the intended system.
  • Need for invasive treatment of complications of the procedure.

Key Trial Info

Start Date :

May 25 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 14 2025

Estimated Enrollment :

122 Patients enrolled

Trial Details

Trial ID

NCT05292326

Start Date

May 25 2021

End Date

March 14 2025

Last Update

September 22 2025

Active Locations (7)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (7 locations)

1

I Cardiology Clinic, Medical University in Poznań

Poznan, Poland, 61-848

2

Wolski Hospital, Cardiology Ward

Warsaw, Poland, 01-211

3

Cardiology Clinic, Medical University of Warsaw

Warsaw, Poland, 02-091

4

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

Warsaw, Poland, 02-507