Status:
COMPLETED
Data Analysis and Evaluation of the Incidence of Life-threatening Ventricular Arrhythmias in Patients with Newly Diagnosed Cardiomyopathies of NICM or MI/CAD Origin PROTECTED from SCD by a WCD
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Zoll CMS GmbH
Conditions:
Cardiomyopathy (Ischemic or Non-Ischemic)
Eligibility:
All Genders
18+ years
Brief Summary
SCD-PROTECT is an epidemiological, observational, multicenter study to assess the incidence of sudden cardiac arrest/death (SCA/SCD) in patients with newly diagnosed non-ischemic cardiomyopathy or wit...
Detailed Description
SCD-PROTECT is an epidemiological, observational, multicenter study, evaluating the incidence of sudden cardiac arrest (SCA) / sudden cardiac death (SCD) in patients with reduced left ventricular ejec...
Eligibility Criteria
Inclusion
- Subjects must be 18 years of age or older.
- Subjects must be prescribed a WCD for a high risk of SCD.
- Subjects must have been fitted with a WCD, and a baseline for ECG-analysis must have been established.
- Subjects must have worn the WCD; time zero of inclusion is the activation of the ECG.
- Subjects must have had a diagnosis of newly diagnosed NICM or MI/CAD with reduced LVEF as indication for WCD prescription.
Exclusion
- No specific exclusion criteria will be applied.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
19598 Patients enrolled
Trial Details
Trial ID
NCT06883383
Start Date
December 1 2021
End Date
December 31 2023
Last Update
March 19 2025
Active Locations (1)
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1
Hannover Medical School
Hanover, Germany, 30625