Cardiomyopathy (Ischemic or Non-Ischemic)SCD-PROTECTNCT06883383
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
An observational study of Cardiomyopathy (Ischemic or Non-Ischemic), run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy (Ischemic or Non-Ischemic)
- How many people
- 19,598 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- No specific exclusion criteria will be applied.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- sudden cardiac arrest, sudden cardiac death, non-ischemic cardiomyopathy, dilated cardiomyopathy, wearable cardioverter-defibrillator, left ventricular ejection fraction, ischemic cardiomyopathy
- Medical subject headings
- Cardiomyopathies, Ischemia, Death, Sudden, Cardiac, Cardiomyopathy, Dilated
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Percentage of patients with inappropriate shocks observed during WCD-use. Events will be automatically recorded through the monitoring device.
Measured: 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
Measured: 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
Measured: Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Dec 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy (Ischemic or Non-Ischemic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 19,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Zoll CMS GmbH
- Responsible party
- Principal investigator, David Duncker, Hannover Medical School
- Investigators
- Johann Bauersachs, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883383
- Sponsor's protocol ID
- SCD-PROTECT
- Acronym
- SCD-PROTECT
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06883383
- Acronym / sponsor ID
- SCD-PROTECT / SCD-PROTECT
- Keywords
- sudden cardiac arrest, sudden cardiac death, non-ischemic cardiomyopathy, dilated cardiomyopathy, wearable cardioverter-defibrillator, left ventricular ejection fraction, ischemic cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,598 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Zoll CMS GmbH
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- No specific exclusion criteria will be applied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of SCD/SCA
Time frame: 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.
3 secondary outcomes
Incidence of inappropriate shocks
Time frame: Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months
Mortality
Time frame: Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months
Adverse events
Time frame: Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann Bauersachs, MD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy (Ischemic or Non-Ischemic), run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of SCD/SCA (time frame: Observation period starts with baseline of WCD-use and continues through end of WCD-use, an average of 2-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.