Registry of Device Implantation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorKlinik für Kardiologie, Pneumologie und Angiologie

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • implantation of cardiac devices

    Device

    implantation of cardiac devices

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

device related adverse events

Adverse events as occurrence of perioperative and postoperative complication related to the device implantation during the index hospital admission

Time frame
during index hospital admission
2

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

Time frame
during index hospital admission

Secondary outcomes

1

survival

Time frame
12 months
2

Clinical Events

free from clinical events (death, syncope, hospital admission due to cardiac problems, and VT storm \[defined as more than three VT episodes in 24 hours\])

Time frame
12 months
3

hospitalization

hospitalization due to cardiac disease and therapy

Time frame
12 months
4

number of appropriate and inappropriate ICD therapies (ATP or shock)

number of appropriate and inappropriate ICD therapies (ATP or shock)

Time frame
12 months

Other outcomes

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