WCD
DeviceAn 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
NCT Number: NCT06570902
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Kerckhoff Klinik, Bad Nauheim, Hesse, Germany
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%.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
Time frame: Enrollment till WCD End of Use, usually up to three month
Quality of Life (QoL) information will be collected using the following questionnaires:
Time frame: Enrollment till WCD End of Use, usually up to three month
Quality of Life (QoL) information will be collected using the following questionnaires:
Time frame: Enrollment till WCD End of Use, usually up to three month
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
Information (days, reasons) on any hospitalizations, emergency room visits, observation stays, urgent care visits, other physician office visits, and stays at skilled nursing facilities.
Contact information is provided by the study sponsor or research team.
Zoll Medical Corporation
Industry
Prospective WCD Post CABG Registry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05524077
Aortic Stenosis, Subvalvular, Aortic Valve Disease
Camperdown, New South Wales, Australia
View Trial DetailsNCT06556485
Arrhythmia, Ventricular, Arrhythmias, Cardiac
Bad Oeynhausen, Germany
View Trial DetailsNCT04014946
Cardiomyopathy Ischemic, ICD
View Trial DetailsNCT07617844
Cardiomyopathies, Cardiomyopathy
Hangzhou, Zhejiang, China
View Trial Details