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Registry of Device Implantation

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ClinicalTrials.gov Identifier: NCT03360227
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

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.


Condition or disease Intervention/treatment
Syncope Bradycardia Tachycardia Sudden Cardiac Death Ventricular Tachycardia Ventricular Fibrillation Device: implantation of cardiac devices

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Registry of Device Implantation in University Hospital Duesseldorf
Actual Study Start Date : January 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: implantation of cardiac devices
    implantation of cardiac devices


Primary Outcome Measures :
  1. device related adverse events [ Time Frame: during index hospital admission ]
    Adverse events as occurrence of perioperative and postoperative complication related to the device implantation during the index hospital admission

  2. Adverse Events [ Time Frame: 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 :
  1. survival [ Time Frame: 12 months ]
  2. Clinical Events [ Time Frame: 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])

  3. hospitalization [ Time Frame: 12 months ]
    hospitalization due to cardiac disease and therapy

  4. number of appropriate and inappropriate ICD therapies (ATP or shock) [ Time Frame: 12 months ]
    number of appropriate and inappropriate ICD therapies (ATP or shock)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who undergo cardiac device implantation in University Hospital Düsseldorf
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360227


Contacts
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Contact: Hisaki Makimoto, MD +492118118800

Locations
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Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine Recruiting
Düsseldorf, Germany, 40225
Contact: Hisaki Makimoto, MD         
Contact: Rabea Wagstaff, M.A.         
Principal Investigator: Hisaki Makimoto, MD         
Sub-Investigator: Alexander Fürnkranz, MD         
Sub-Investigator: Jan Schmidt, MD         
Sub-Investigator: Muhammed Kurt, MD         
Sub-Investigator: Lukas Clasen, MD         
Sub-Investigator: Christoph Brinkmeyer, MD         
Sub-Investigator: Patrick Müller, MD         
Sub-Investigator: Alexandru Bejinariu, MD         
Sponsors and Collaborators
Klinik für Kardiologie, Pneumologie und Angiologie
Investigators
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Principal Investigator: Hisaki Makimoto, MD Division of Cardiology, Pulmonary Disease and Vascular Medicine

Additional Information:

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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Principal Investigator, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT03360227     History of Changes
Other Study ID Numbers: 15-019
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
syncope
bradycardia
tachycardia
sudden cardiac death
implantable cardioverter-defibrillator
ventricular tachycardia
ventricular fibrillation
biomarker
thyroid hormone

Additional relevant MeSH terms:
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Ventricular Fibrillation
Tachycardia
Tachycardia, Ventricular
Syncope
Death
Death, Sudden, Cardiac
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Heart Arrest
Death, Sudden