Prospective WCD Post CABG Registry (CABG Registry)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZoll Medical Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 UseSecondary outcomes
1
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 month2
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 month3
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 month4
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 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov