Registry of Device Implantation

Recruiting

• Conditions: Bradycardia; Syncope; Ventricular Tachycardia; Ventricular Fibrillation; Tachycardia; Sudden Cardiac Death

• Registration Number: NCT03360227
• Lead Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

Brief Summary

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.

Detailed Description

The implantation of cardiac devices has been one of the common standard procedures in the cardiac clinical practice.

Pacemakers are implanted for patients with symptomatic bradyarrhythmias. Implantable cardioverter-defibrillators are implanted in order to avoid sudden cardiac death (SCD) in high risk patients such as after myocardial infarction and reduced ejection fraction.

Cardiac resynchronization therapy was introduced to improve the prognosis in patients with reduced EF and left bundle branch block. This therapy demonstrated the efficacy in severe heart failure patients.

Recently a new implantable device has been developed also to improve the prognosis of patients with severe heart failure refractory to the maximal therapies at present. This barostimulator activates the baro-reflex and results in higher parasympathetic activity and better outcome in those patients, in whom the sympathetic function is overactivated.

In patients with cryptogenic stroke or syncope, the implantable loop recorder enables us to monitor the cardiac rhythm continuously for 3 years. With this device, the occult arrhythmias can be revealed and lead patients to the adequate therapy.

Above mentioned device therapies have been developed since 1960s, and the technologies in this field are still progressively developing. To catch up these advancements, the quality management including the efficacy, safety aspects and the prognosis of the patients should be carefully monitored.

The aim of the present study is, therefore, to demonstrate the efficacy and the safety of standard device implantation procedures. The patient specific and procedural factors are evaluated to test if those factors predict the prognosis of the patients. These identifications will eventually result in the improvement of future patients' care.

The data of patients who underwent device implantation since 2011 and those who undergo device implantation till 2019 will be collected, including the basic demographic data, comorbidities, results of laboratory and functional tests. In the latter patients, the peri-procedural data and post-procedural data are also prospectively collected.

The present study is essentially an observational study. The inclusion in this study does not affect the decision of device implantation itself. The post-procedural therapies, such as medications and device therapies are not due to this registry affected.

As a sub-project in this registry, biomarkers and thyroid hormone are evaluated to investigate the predictable value of those indices.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-04
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. pre-operative clinical history taking
2. pre-operative functional investigations (cardiac echo, electrocardiograms)
3. pre-operative laboratory data evaluation (kidney function, liver function, biomarkers, thyroid hormone, CBC)

Exclusion Criteria

１. no written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
device related adverse events	during index hospital admission	Adverse events as occurrence of perioperative and postoperative complication related to the device implantation during the index hospital admission
Adverse Events	during index hospital admission	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 Outcome Measures

Name	Time	Method
survival	12 months
Clinical Events	12 months	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	12 months	hospitalization due to cardiac disease and therapy
number of appropriate and inappropriate ICD therapies (ATP or shock)	12 months	number of appropriate and inappropriate ICD therapies (ATP or shock)

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Düsseldorf, Germany