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

Completed

• Conditions: Cardiomyopathy (Ischemic or Non-Ischemic)

• Registration Number: NCT06883383
• Lead Sponsor: Hannover Medical School

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.

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 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 arrhythmia monitoring, detection of life-threatening ventricular arrhythmias, and provides automatic defibrillation within a minute of detection of a potentially fatal ventricular tachyarrhythmia whatever the cause of increased risk of SCD. Currently, detailed data for risk of SCA/SCD in patients with NICM or MI/CAD during the early phase are sparse.

The SCD-PROTECT study is a comprehensive, nationwide analysis of at least 18.000 consecutive patients using a WCD (LifeVest®, ZOLL, Pittsburgh, PA, USA) in Germany to evaluate the risk of SCA/SCD in the early phase of disease.

All patients who received a WCD (LifeVest®, ZOLL, Pittsburgh, PA, USA) from December 2021 to May 2023 in Germany will be screened for inclusion. Observation period will start with first ECG recording of the WCD and terminates with individual end-of-WCD-use. Primary objective is the SCA/SCD incidence, measured by the percentage of patients with at least one appropriate treatment (appropriate shock) delivered and automatically recorded by WCD. The incidence density of appropriate shocks per 100 patient years will also be calculated.

Secondary objectives include inappropriate WCD treatments, mortality and side effects during WCD wearing time. Exploratory objectives are trajectory of LVEF, compliance with WCD use, time to first appropriate shock from beginning of wearing time until first WCD shock and incidences of appropriate shocks (primary endpoint) by subtype of NICM or MI/CAD.

NICM and MI/CAD sub-types are categorized by the investigator team at baseline and may include the following: DCM, Myocarditis, PPCM, Tako-Tsubo CM, Tachymyopathy, Toxic CM, Sarcoidosis Genetic/Congenital, and others vs. Post Myocardial Infarction, Coronary Heart Disease and others.

Patient data are extracted from routinely collected medical records by analysts, blinded to the outcomes.

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19598

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of SCD/SCA	Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months	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.

Secondary Outcome Measures

Name	Time	Method
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	Percentage of patients with inappropriate shocks observed during WCD-use. Events will be automatically recorded through the monitoring device.
Mortality	Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months	Percentage of death during observation period
Adverse events	Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months	Adverse events during observation period

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany