Cardiomyopathy IschemicNCT06570902
Prospective WCD Post CABG Registry (CABG Registry)
An observational study of Cardiomyopathy Ischemic and Cardiomyopathies, run by Zoll Medical Corporation at 4 sites in Germany.
Trial summary
The primary objective is to observe the rate of recovery of ventricular function (EF>35%) after first-time coronary artery bypass graft surgery in patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy Ischemic, Cardiomyopathies, Cardiovascular Diseases
- What is being tested?
- WCD
- Type of treatment
- Medical device
- How many people
- 910 participants
- Where
- 4 sitesGermany
- Study dates
- 23 Sep 2024to May 2030
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care
Who may be able to join
- Patient underwent first-time CABG surgery <10 days before enrollment.
- Patient is prescribed WCD for a primary reason of HF with reduced EF < 35% measured after surgery but before hospital discharge.
- Patient is ≥18 years old
Who cannot join
- Patients having combination CABG surgery with heart valve repair.
- Patients with prior CABG.
- Patients who have an active unipolar pacemaker.
- Patients with a physical or mental condition that could impair their ability to properly interact with the WCD.
- Patients currently participating in an interventional clinical study. Patients with any skin condition that would prevent wearing the device. Patients with an advanced directive prohibiting resuscitation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Horst-O. Esser contact
Germany4 sites, 4 recruiting
- Not yet recruiting
Kerckhoff Klinik
Bad Nauheim, Hesse, 61231
Heiko Burger (Dr.), MD
- Recruiting
Sana-Herzzentrum Cottbus GmbH
Cottbus, 03048
Tomasz Stankowski, MD
Tomasz Stankowski, MD
- Recruiting
Universitätsklinikum Halle (Saale)
Halle, 06120
Songül Secer, MD
Songül Secer, MD
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Christian Kühn (Prof. Dr.), MD
About this study
Official title: Prospective WCD Post CABG Registry
The primary objective is to observe the rate of recovery of ventricular function (EF>35%) after first-time coronary artery bypass graft surgery in patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care.
Read the detailed description
The primary objective of this study is to determine the rate of recovery of ventricular function (EF>35%) in patients with ischemic heart failure with reduced ejection fraction (EF ≤35%) after undergoing first time, coronary artery bypass grafting (CABG) procedure while being treated with guideline-directed medical therapy (GDMT). It is anticipated that more patients will have EF recovery as compared to a retrospective register where 54% of isolated CABG patients had EF recovery by end of WCD use (Kuehn et al., 2022), mostly driven by the modern improved usage of GDMT drugs.
This study is designed as a multi-center prospective observational study of patients who underwent first time coronary artery bypass grafting procedure with HFrEF at hospital discharge to test the hypothesis that EF recovery will be improved by end of WCD wear due to increased usage of GDMT. The study will target 20% female enrollment and recruitment will be adjusted if the percentage of female subjects enrolled are far from 20%.
- Conditions
- Cardiomyopathy Ischemic, Cardiomyopathies, Cardiovascular Diseases, Heart Disease, Ischemic
- Being tested
- WCD
- Medical subject headings
- Cardiomyopathies, Cardiovascular Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WCDDevice
An FDA-approved, CE marked WCD will be prescribed for up to 3 months of use after hospital discharge, with the option for longer use under physician discretion
What is being measured
The primary outcome is the main question the study is designed to answer.
EF recovery
EF recovery at end of WCD use, usually after 90days of wear. End of WCD use will be determined by the prescribing physician. For this study, EF>35% will be considered as EF recovery.
Measured: Enrollment till WCD End of Use
Secondary outcomes (4)
Quality of Life (KCCQ
Quality of Life (QoL) information will be collected using the following questionnaires:
- Kansas City Cardiomyopathy Questionnaire short form (KCCQ-12)
Measured: Enrollment till WCD End of Use, usually up to three month
Quality of Life EQ
Quality of Life (QoL) information will be collected using the following questionnaires:
- EQ-5D-5L
Measured: Enrollment till WCD End of Use, usually up to three month
Medication Adherence
Medications and self-reported adherence to taking those medications as prescribed will be recorded from chart review and patient interview, if necessary, every month (30 days). Medications will also be recorded at the start and end of WCD use
Measured: Enrollment till WCD End of Use, usually up to three month
Healthcare utilization
Information (days, reasons) on any hospitalizations, emergency room visits, observation stays, urgent care visits, other physician office visits, and stays at skilled nursing facilities.
Measured: Enrollment till WCD End of Use, usually up to three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start23 Sep 2024
- Primary completionNov 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy IschemicStudies 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
- Prospective
- Enrolment
- 910 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570902
- Sponsor's protocol ID
- 90D0270
- Status last verified
- Oct 2024
- First submitted
- 28 Jul 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective WCD Post CABG Registry
- ClinicalTrials.gov ID
- NCT06570902
- Acronym / sponsor ID
- 90D0270
- Conditions
- Cardiomyopathy Ischemic, Cardiomyopathies, Cardiovascular Diseases, Heart Disease, Ischemic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 910 participants (estimated)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 26 Aug 2024 (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.
The primary objective is to observe the rate of recovery of ventricular function (EF>35%) after first-time coronary artery bypass graft surgery in patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care.
Detailed description
The primary objective of this study is to determine the rate of recovery of ventricular function (EF>35%) in patients with ischemic heart failure with reduced ejection fraction (EF ≤35%) after undergoing first time, coronary artery bypass grafting (CABG) procedure while being treated with guideline-directed medical therapy (GDMT). It is anticipated that more patients will have EF recovery as compared to a retrospective register where 54% of isolated CABG patients had EF recovery by end of WCD use (Kuehn et al., 2022), mostly driven by the modern improved usage of GDMT drugs.
This study is designed as a multi-center prospective observational study of patients who underwent first time coronary artery bypass grafting procedure with HFrEF at hospital discharge to test the hypothesis that EF recovery will be improved by end of WCD wear due to increased usage of GDMT. The study will target 20% female enrollment and recruitment will be adjusted if the percentage of female subjects enrolled are far from 20%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care
Key inclusion criteria (3 listed)
- Patient underwent first-time CABG surgery <10 days before enrollment.
- Patient is prescribed WCD for a primary reason of HF with reduced EF < 35% measured after surgery but before hospital discharge.
- Patient is ≥18 years old
Key exclusion criteria (5 listed)
- Patients having combination CABG surgery with heart valve repair.
- Patients with prior CABG.
- Patients who have an active unipolar pacemaker.
- Patients with a physical or mental condition that could impair their ability to properly interact with the WCD.
- Patients currently participating in an interventional clinical study. Patients with any skin condition that would prevent wearing the device. Patients with an advanced directive prohibiting resuscitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WCDAn FDA-approved, CE marked WCD will be prescribed for up to 3 months of use after hospital discharge, with the option for longer use under physician discretion | Device | – |
Primary outcome
EF recovery
Time frame: Enrollment till WCD End of Use
EF recovery at end of WCD use, usually after 90days of wear. End of WCD use will be determined by the prescribing physician. For this study, EF>35% will be considered as EF recovery.
4 secondary outcomes
Quality of Life (KCCQ
Time frame: Enrollment till WCD End of Use, usually up to three month
Quality of Life EQ
Time frame: Enrollment till WCD End of Use, usually up to three month
Medication Adherence
Time frame: Enrollment till WCD End of Use, usually up to three month
Healthcare utilization
Time frame: Enrollment till WCD End of Use, usually up to three month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Horst-O. Esser contact
4 sites 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 and Cardiomyopathies, run by Zoll Medical Corporation at 4 sites 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Weber, M.Sc. (015161140498, lweber@zoll.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EF recovery (time frame: Enrollment till WCD End of Use). 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 4 Nov 2024; AzTrials last refreshed its copy on 27 Oct 2026.