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

NCT06883383 | Completed

• 1 other identifier: SCD-PROTECT
• Study Type: observational
• Target: 19,598
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cardiomyopathy (Ischemic or Non-Ischemic)

Keywords

sudden cardiac arrest; sudden cardiac death; non-ischemic cardiomyopathy; dilated cardiomyopathy; wearable cardioverter-defibrillator; left ventricular ejection fraction; ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Incidence of SCD/SCA

  Incidence of patients with NICM or MI/CAD with at least one appropriate treatment (appropriate shock) observed during WCD-use. Treatment events will be automatically recorded through the monitoring device. The incidence density of appropriate shocks per 100 patient years will also be calculated.

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

Secondary Outcomes (3)

• Incidence of inappropriate shocks

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

• Mortality

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

• Adverse events

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

Other Outcomes (5)

• Average WCD wear-time in days

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

• WCD compliance

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

• Cumulative Incidences of appropriate treatments per sub-etiologies

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

Eligibility Criteria

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

Study Population

The study includes consecutively all patients with NICM or MI/CAD diagnosis and WCD usage (LifeVest®, ZOLL, Pittsburgh, PA, USA) in Germany. The Zoll database systematically registers all patients who are prescribed the LifeVest® in Germany. For this study, data from the ZPM (Zoll Patient Management System), which holds the recordings of the WCD is also integrated to assess treatments and compliance. All patients with NICM or MI/CAD indication, entered in the ZOLL database since December 2021 will be enrolled retrospectively into the study. From January 2023 to May 2023 patients will be prospectively enrolled following the same protocol.

You may qualify if:

• 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 had a diagnosis of newly diagnosed NICM or MI/CAD with reduced LVEF as indication for WCD prescription.

Sponsors & Collaborators

• Hannover Medical School: lead
• Zoll CMS GmbH: collaborator

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Cardiomyopathies; Ischemia; Death, Sudden, Cardiac; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Johann Bauersachs, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hannover Heart Rhythm Center, Department of Cardiology and Angiology

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 19, 2025
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)