Registry of Device Implantation

Registry of Device Implantation in University Hospital Duesseldorf

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.

Study Overview

• Status: Recruiting
• Conditions: Bradycardia; Syncope; Ventricular Fibrillation; Ventricular Tachycardia; Tachycardia; Sudden Cardiac Death
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Hisaki Makimoto, MD; Phone Number: +492118118800

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Recruiting
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine
    • Contact: Hisaki Makimoto, MD
    • Contact: Rabea Wagstaff, M.A.
    • Principal Investigator: Hisaki Makimoto, MD
    • Sub-Investigator: Alexander Fürnkranz, MD
    • Sub-Investigator: Patrick Müller, MD
    • Sub-Investigator: Lukas Clasen, MD
    • Sub-Investigator: Jan Schmidt, MD
    • Sub-Investigator: Muhammed Kurt, MD
    • Sub-Investigator: Christoph Brinkmeyer, MD
    • Sub-Investigator: Alexandru Bejinariu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo cardiac device implantation in University Hospital Düsseldorf

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
device related adverse events	Adverse events as occurrence of perioperative and postoperative complication related to the device implantation during the index hospital admission	during 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	during index hospital admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival		12 months
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])	12 months
hospitalization	hospitalization due to cardiac disease and therapy	12 months
number of appropriate and inappropriate ICD therapies (ATP or shock)	number of appropriate and inappropriate ICD therapies (ATP or shock)	12 months

Collaborators and Investigators

• Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Anticipated): December 1, 2030
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: biomarker; syncope; sudden cardiac death; ventricular tachycardia; bradycardia; ventricular fibrillation; tachycardia; implantable cardioverter-defibrillator; thyroid hormone
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Death, Sudden; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Heart Arrest; Death; Bradycardia; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Syncope; Death, Sudden, Cardiac
• Other Study ID Numbers: 15-019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No