Carepace compression system compared to standard postoperative threatment after pacemaker or defibrillator implant

Not Applicable

Recruiting

Conditions: T81.0
T82.1
Haemorrhage and haematoma complicating a procedure, not elsewhere classified
Mechanical complication of cardiac electronic device

Registration Number: DRKS00009808

Lead Sponsor: Medizinische Klinik m. S. Kardiologie Rhythmologie-Elektrophysiologie und Devicetherapie; Charité Campus Virchow Klinikum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Planned primary implenation of pacemaker or ICD.
-Therapy with at least one antiplatelet or an oral anticoagulant -
-Age over 18 years
-Capacity to consent
-Existence of a written informed consent form

Exclusion Criteria

-Clear idication for one of the possible prodcedere
-Pregnancy
-Legally in medical matters supervised patients
-Participation in another interventional study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of clinical relevant hematoma are defined by a hematoma-score:<br>- size >20x20cm and decrease of hemoglobin >2 points<br>- palpable mass of hematoma, min. 2 cm<br>- prolongation of hospital stay<br>- pocket infection caused by existing hematoma <br>- reoperation required due to hematoma<br>- running anticoagulation has to be reduced or paused<br><br>The occurrrence of clinical relevant hematoma will be checked on <br>a) the first postoperative day and<br>b) between the 11.-15. postoperative day.<br>c) after 6 weeks final follow-up

Secondary Outcome Measures

Name	Time	Method
Secondary outcome such as displacement of materials, pocket infections and prolonged wound healing will be mesured by their typically clinical appereance the first day postoperative and between the 11.-15. day after surgery.