An observational study in Cardiomyopathy Ischemic, Cardiomyopathies and Cardiovascular Diseases, sponsored by Zoll Medical Corporation. Recruiting at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-04.
Sponsored by Zoll Medical Corporation · Observational
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.
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%.
553 studies on the registry are indexed under Cardiomyopathies; 152 are open to participants now.
This study's planned enrollment of 910 is above the median of 200 across 263 observational studies indexed under Cardiomyopathies.
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Patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care
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Exclusion Criteria:
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.
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
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.
Time frame: Enrollment till WCD End of Use
Quality of Life (KCCQ
Quality of Life (QoL) information will be collected using the following questionnaires: - Kansas City Cardiomyopathy Questionnaire short form (KCCQ-12)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Enrollment till WCD End of Use, usually up to three month
Plan to share: Undecided
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