Registry of Device Implantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bradycardia
- Sudden Cardiac Death
- Syncope
- Tachycardia
- Ventricular Fibrillation
- Ventricular Tachycardia
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 ris...
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.
Tracking Information
- NCT #
- NCT03360227
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Hisaki Makimoto, MD Division of Cardiology, Pulmonary Disease and Vascular Medicine