NCT06570902

Prospective WCD Post CABG Registry (CABG Registry)

Prospective WCD Post CABG Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 910 (estimated)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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

Interventions

Type	Name	Description
DEVICE	WCD	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

Timeline

• Start date: 2024-09-23
• Primary completion: 2029-11-01
• Completion: 2030-05-01
• First posted: 2024-08-26
• Last updated: 2024-11-04

Locations

4 sites across 1 country: Germany

Regulatory

• FDA-regulated device study