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 (SCD-PROTECT)

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.

Study Overview

• Status: Completed
• Conditions: Cardiomyopathy (Ischemic or Non-Ischemic)

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 Type: Observational
• Enrollment (Actual): 19598

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Hannover Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average WCD wear-time in days	Average WCD wear-time in days, from baseline until end of WCD-use, measured 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	Compliance, meaning average wear-time of the WCD per day, measured in hours per day.	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	Cumulative Incidences of appropriate treatments per sub-etiologies, measured in events per 100 patient-years	Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months
Time from baseline of WCD-use until first appropriate WCD-treatment	Time from baseline of WCD-use until first appropriate WCD-treatment, measured in days	From baseline of WCD-use until first appropriate treatment by the WCD, assessed through end of WCD use, an average of 2-3 months
Trajectory of left ventricular ejection fraction (LVEF)	Trajectory of left ventricular ejection fraction (LVEF), measured in percent LVEF at the time-points pre-hospital, at hospital discharge (corresponding to baseline of WCD-use), and at end of WCD-use	Pre-hospital (up to one year), at hospital discharge (assessed up to 3 days), and at end of WCD use (an average of 2-3 months from base line)

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Zoll CMS GmbH
• Investigators: Principal Investigator: Johann Bauersachs, MD, Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: dilated cardiomyopathy; sudden cardiac death; ischemic cardiomyopathy; left ventricular ejection fraction; non-ischemic cardiomyopathy; sudden cardiac arrest; wearable cardioverter-defibrillator
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies
• Other Study ID Numbers: SCD-PROTECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No