Registry of Device Implantation

NCT03360227 | Recruiting

• 1 other identifier: 15-019
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Syncope; Bradycardia; Tachycardia; Sudden Cardiac Death; Ventricular Tachycardia; Ventricular Fibrillation

Keywords

syncope; bradycardia; tachycardia; sudden cardiac death; implantable cardioverter-defibrillator; ventricular tachycardia; ventricular fibrillation; biomarker; thyroid hormone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• survival

  12 months

• Clinical Events

  12 months

• hospitalization

  12 months

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

  12 months

Interventions

implantation of cardiac devices DEVICE

implantation of cardiac devices

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo cardiac device implantation in University Hospital Düsseldorf

You may qualify if:

• 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)

You may not qualify if:

• １. no written informed consent

Sponsors & Collaborators

• Klinik für Kardiologie, Pneumologie und Angiologie: lead

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Syncope; Bradycardia; Tachycardia; Death, Sudden, Cardiac; Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Cardiac Conduction System Disease; Heart Arrest; Death, Sudden; Death

Study Officials

• Hisaki Makimoto, MD

  Division of Cardiology, Pulmonary Disease and Vascular Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hisaki Makimoto, MD

CONTACT

+492118118800

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: December 4, 2017
• Study Start: January 1, 2011
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 7, 2020

Record last verified: 2020-02

Locations

DE (1)