Image

Prospective WCD Post CABG Registry (CABG Registry)

Prospective WCD Post CABG Registry (CABG Registry)

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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%.

Eligibility

Inclusion Criteria

  • 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 Criteria:

  • 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.

Study details
    Cardiomyopathy Ischemic
    Cardiomyopathies
    Cardiovascular Diseases
    Heart Disease
    Ischemic

NCT06570902

Zoll Medical Corporation

1 September 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.