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NCT Number: NCT06570902

Prospective WCD Post CABG Registry (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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kerckhoff Klinik, Bad Nauheim, Hesse, Germany

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About this study

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%.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WCD

Device

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

Primary outcomes

  1. EF recovery

    Time frame: Enrollment till WCD End of Use

    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.

Secondary outcomes

  1. Quality of Life (KCCQ

    Time frame: Enrollment till WCD End of Use, usually up to three month

    Quality of Life (QoL) information will be collected using the following questionnaires:

    • Kansas City Cardiomyopathy Questionnaire short form (KCCQ-12)
  2. Quality of Life EQ

    Time frame: Enrollment till WCD End of Use, usually up to three month

    Quality of Life (QoL) information will be collected using the following questionnaires:

    • EQ-5D-5L
  3. Medication Adherence

    Time frame: Enrollment till WCD End of Use, usually up to three month

    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

  4. Healthcare utilization

    Time frame: Enrollment till WCD End of Use, usually up to three month

    Information (days, reasons) on any hospitalizations, emergency room visits, observation stays, urgent care visits, other physician office visits, and stays at skilled nursing facilities.

Study contacts

Contact information is provided by the study sponsor or research team.

Horst-O. Esser

CONTACT

[email protected]

Lars Weber, M.Sc.

CONTACT

[email protected]

015161140498

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Official study title

Prospective WCD Post CABG Registry

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Aug 26, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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