Ventricular Tachycardia Clinical Trial
— RACE-ITOfficial title:
Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions
NCT number | NCT02982473 |
Other study ID # | 2016-612N-MA |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | July 2022 |
The "Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics
and Interventions (RACE-IT)" represents a mono-centric registry of patients being
hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation)
and sudden cardiac death (SCD).
Detailed findings of patients' clinical outcome regarding mortality and co-morbidities
related to the presence of invasive diagnostics or therapies including coronary angiography,
percutaneous coronary intervention (PCI), electrophysiological testing (EP), catheter
ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will be
documented. Patients will be included when being hospitalized from the year 2004 until today.
Status | Recruiting |
Enrollment | 3200 |
Est. completion date | July 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Hospitalization due to: - ventricular tachycardia - ventricular fibrillation - sudden cardiac death Exclusion Criteria: - not diagnosed with one or more of the above |
Country | Name | City | State |
---|---|---|---|
Germany | First Department of Medicine, University Medical Centre Mannheim | Mannheim |
Lead Sponsor | Collaborator |
---|---|
Universitätsmedizin Mannheim |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of ventricular arrythmias (i.e. ventricular fibrillation, ventricular tachykardia, asystole, SCD) | Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime | ||
Secondary | Incidence of coronary artery disease (CAD) and PCI in patients with VF/VT/SCD | Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime | ||
Secondary | Incidence of invasive electrophysiologic testing (EP) and catheter ablation | Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime | ||
Secondary | Incidence of treatment with cardiac devices (i.e. ICD, CCM, CRT-D) | Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime | ||
Secondary | Incidences of recurrent malignant tachycardias, all-cause mortality, arrhythmia-related death, re-PCI/ACVB, re-ablation, further therapy with cardiac devices | Through study completion, potentially up to 12 years, depending on patient inclusion/first event and patients lifetime |
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