About this trial
The implantable device therapy for cardiac arrhythmias has been an established therapy, and one of the common standard procedures in cardiac clinical practice.
Pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy have been developed since 1960s, and the technologies in this field are still progressively developing. Not only these "traditional" implantable devices, there are multiple new devices for cardiac diseases, such as implantable loop recorder, vagal nerve stimulator and barostimulator.
The aim of this registry is to demonstrate the efficacy and the safety of standard device implantation procedures and to evaluate/ identify specific factors, including clinical characteristics, laboratory data and procedural data, which predict the prognosis/complication of the patients. These identification will result in further improvement of patients' care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
pre-operative clinical history taking
pre-operative functional investigations (cardiac echo, electrocardiograms)
pre-operative laboratory data evaluation (kidney function, liver function, biomarkers, thyroid hormone, CBC)
Disqualifiers
None
Trial population
Patients who undergo cardiac device implantation in University Hospital Düsseldorf
Trial design
Other
Prospective
Treatments tested in this trial
implantation of cardiac devices
Deviceimplantation of cardiac devices
Treatment groups
Trial outcomes
Primary outcomes
device related adverse events
Adverse events as occurrence of perioperative and postoperative complication related to the device implantation during the index hospital admission
Adverse Events
Adverse Events as occurrence of atrial fibrillation, occurrence of syncope, occurrence of sustained ventricular tachycardia (VT), ventricular fibrillation (VF) or appropriate ICD therapy including antitachycardia pacing (ATP) and shock, occurrence of inadequate ICD therapy including ATP and shock in ICD/CRT-D patients, hospital admission due to cardiac disease and therapy, cardiac death
Secondary outcomes
survival
Clinical Events
free from clinical events (death, syncope, hospital admission due to cardiac problems, and VT storm \[defined as more than three VT episodes in 24 hours\])
hospitalization
hospitalization due to cardiac disease and therapy
number of appropriate and inappropriate ICD therapies (ATP or shock)
number of appropriate and inappropriate ICD therapies (ATP or shock)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Klinik für Kardiologie, Pneumologie und Angiologie
Lead sponsor
Heinrich-Heine University, Duesseldorf
Sponsor institution