CompletedNot Applicable

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

Germany19,598 participantsStarted 2021-12-01

Plain-language 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 with myocardial infarction/coronary artery disease. Data on SCA/SCD risk in the early phase of disease, especially during medication up-titration while left ventricular ejection fraction is reduced, are sparse.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * No specific exclusion criteria will be applied.

What they're measuring

Incidence of SCD/SCA

Timeframe: Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months

Trial details

NCT IDNCT06883383

SponsorHannover Medical School

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Cardiomyopathy (Ischemic or Non-Ischemic) trials