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Search / Trial NCT06883383

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

Launched by HANNOVER MEDICAL SCHOOL · Mar 12, 2025

Trial Information

Current as of April 29, 2025

Completed

Keywords

Sudden Cardiac Arrest Sudden Cardiac Death Non Ischemic Cardiomyopathy Dilated Cardiomyopathy Wearable Cardioverter Defibrillator Left Ventricular Ejection Fraction Ischemic Cardiomyopathy

ClinConnect Summary

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 ejection fraction (LVEF) due to newly diagnosed non-ischemic cardiomyopathy (NICM) or a myocardial infarction/coronary artery disease with intervention (MI/CAD). In the early phase (3 months) during up-titration of guideline-recommended therapy (GRMT) a wearable cardioverter defibrillator (WCD) can be indicated due to increased risk for SCA/SCD in these patients. The WCD provides continuous arrhyth...

Gender

ALL

Eligibility criteria

  • 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.

About Hannover Medical School

Hannover Medical School (Medizinische Hochschule Hannover, MHH) is a leading academic medical institution in Germany, renowned for its commitment to innovative research and high-quality clinical care. Established in 1965, MHH specializes in a wide range of medical disciplines, with a strong focus on transplantation medicine, regenerative medicine, and personalized healthcare. The institution actively participates in clinical trials to advance medical knowledge and develop cutting-edge therapies, leveraging its state-of-the-art facilities and collaborative environment. With a dedicated team of researchers, clinicians, and support staff, Hannover Medical School aims to translate scientific findings into practical applications that improve patient outcomes and enhance the overall quality of healthcare.

Locations

Hannover, , Germany

Patients applied

0 patients applied

Trial Officials

Johann Bauersachs, MD

Principal Investigator

Hannover Medical School

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported