Clinical trial NCT05292326: Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoing CIED Implantation.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemorrhagic Complications
Hematoma
Hemorrhage
Pathologic Processes
Keywords: CIED Implantation
Hemorrhagic Complications
hematoma
pocket hematoma
bleeding risk score
cardiac implantable electronic device
Lead sponsor: Medinice S.A.
Sponsor class: INDUSTRY
First posted: 2022-03-23
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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),
* expantion of the system,
* revision of electrodes.

The study consists in randomization of patients who meet all the inclusion criteria and do not meet any of the exclusion criteria, after performing the above procedure for the group (A): the PacePress medical device will be used, or (B): a standard of care will be used, in order to compare the safety and efficacy of the PacePress in relation to the standard of care, in preventing hemorrhagic complications and site infections.

Data regarding the assessment of the safety and effectiveness of the PacePress medical device are collected on the day of the procedure and during the 30-day patient observation.

In PacePress clinical trial, the standard pharmacotherapeutic procedures in the facility are not modified or affected (including but not limited to the anti-coagulation and antiplatelet treatment) according to the guidelines and standard procedure ESC and PTK in patients included in the study.

The investigational medical device is the PacePress (Medinice S.A.). This is an electronically-controlled self-pressure dressing that, , thanks to a well-selected compression force, may contribute significantly to preventing hemorrhagic complications following electrotherapy procedures, including increasing the safety of CIED implantation procedures and accelerating wound healing significantly.

The planned number of patients included in the study is 235 patients aged above 18 years. The study subjects will be divided into groups at random (4:1):

GROUP A - Following the procedure, the patients will be dressed in the PacePress - investigational medical device instead of a standard compression device.

The planned number of group members: n= 188 people.

GROUP B - Following the procedure, the patients will be dressed in the standard compression device.

The planned number of group members: n= 47 people.

In the study, the assumptions were made concerning the gradation and frequency of hematoma occurrence in particular groups and randomization of patients (4:1). Assuming the first-type error α=0.025 for the one-sided hypothesis and the test power of 0.8, 194 patients should be included in the study. Due to the planned interim analysis, which will be performed after half of the patients have been included in the study, and assuming the drop-out rate of 8 %, the required sample size should be increased to 235 patients.

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.

Primary outcomes:
measure: Assessment of hematoma presence
timeFrame: 7 (-0/+2) days after the procedure
Secondary outcomes:
measure: Emergence of a hematoma
timeFrame: based on 24-48 hour and 30 (+/- 5) day observation
measure: Emergence of a hematoma
timeFrame: based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation
measure: Number of patients who need blood derivative transfusion
timeFrame: based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation
measure: Mortality rate
timeFrame: based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation
measure: Infection
timeFrame: based on 24-48 hour, 7 (-0/+2) day and 30 (+/- 5) day observation
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: I Cardiology Clinic, Medical University in Poznań
city: Warsaw
country: Poland
facility: Wolski Hospital, Cardiology Ward
city: Warsaw
country: Poland
facility: Cardiology Clinic, Medical University of Warsaw
city: Warsaw
country: Poland
facility: Clinical Department of Cardiology, the National Medical Institute of the Ministry of the Interior and Administration
city: Warsaw
country: Poland
facility: I Clinic for Cardiac Arrhythmias National Institute of Cardiology Stefan Cardinal Wyszyński National Research Institute
city: Zabrze
country: Poland
facility: Department of Cardiology / 1st Department of Cardiology and Angiology, Silesian Centre for Heart Diseases
city: Łódź
country: Poland
facility: Electrocardiology Clinic, Medical University
Study officials:
affiliation: Medical University in Poznań
name: Przemysław Mitkowski, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References: