Prospective WCD Post CABG Registry (CABG Registry)

Prospective WCD Post CABG Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Cardiomyopathies; Heart Disease, Ischemic; Cardiomyopathy Ischemic
• Intervention / Treatment: Device: WCD

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%.

• Study Type: Observational
• Enrollment (Estimated): 910

Contacts and Locations

• Study Contact: Name: Lars Weber, M.Sc.; Phone Number: 015161140498; Email: lweber@zoll.com
• Study Contact Backup: Name: Horst-O. Esser; Email: hesser@zoll.com

Study Locations

• Germany
  • Cottbus, Germany, 03048
    • Recruiting
    • Sana-Herzzentrum Cottbus GmbH
    • Contact: Tomasz Stankowski, MD
    • Principal Investigator: Tomasz Stankowski, MD
  • Halle, Germany, 06120
    • Recruiting
    • Universitätsklinikum Halle (Saale)
    • Contact: Songül Secer, MD
    • Principal Investigator: Songül Secer, MD
  • Hessen
    • Bad Nauheim, Hessen, Germany, 61231
      • Not yet recruiting
      • Kerckhoff Klinik
      • Contact: Heiko Burger (Dr.), MD
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Recruiting
      • Medizinische Hochschule Hannover
      • Contact: Christian Kühn (Prof. Dr.), MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Enrollment till WCD End of Use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (KCCQ	Quality of Life (QoL) information will be collected using the following questionnaires: - Kansas City Cardiomyopathy Questionnaire short form (KCCQ-12)	Enrollment till WCD End of Use, usually up to three month
Quality of Life EQ	Quality of Life (QoL) information will be collected using the following questionnaires: - EQ-5D-5L	Enrollment till WCD End of Use, usually up to three month
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	Enrollment till WCD End of Use, usually up to three month
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.	Enrollment till WCD End of Use, usually up to three month

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Pathologic Processes; Ischemia; Cardiovascular Diseases; Heart Diseases; Cardiomyopathies; Myocardial Ischemia
• Other Study ID Numbers: 90D0270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes