RecruitingNCT06570902

Prospective WCD Post CABG Registry (CABG Registry)

Prospective WCD Post CABG Registry

Sponsor

Zoll Medical Corporation

Enrollment

910 participants

Start Date

Sep 23, 2024

Study Type

OBSERVATIONAL

Conditions

Cardiomyopathies Cardiovascular Diseases Cardiomyopathy Ischemic Heart Disease, Ischemic

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria5

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.

Interventions

DEVICEWCD

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