Prospective WCD Post CABG Registry (CABG Registry)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WCD.
- Who it may be relevant to
- Registry conditions: Cardiomyopathy Ischemic, Cardiomyopathies, Cardiovascular Diseases, Heart Disease, Ischemic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective WCD Post CABG Registry
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.
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%.
Interventions
- 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
Primary outcome measures
- EF recovery [Time frame: Enrollment till WCD End of Use]
Secondary outcome measures (4)
- Quality of Life (KCCQ [Time frame: Enrollment till WCD End of Use, usually up to three month]
- Quality of Life EQ [Time frame: Enrollment till WCD End of Use, usually up to three month]
- Medication Adherence [Time frame: Enrollment till WCD End of Use, usually up to three month]
- Healthcare utilization [Time frame: Enrollment till WCD End of Use, usually up to three month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 4 centers
- Kerckhoff Klinik — Bad Nauheim
- Medizinische Hochschule Hannover — Hanover
- Sana-Herzzentrum Cottbus GmbH — Cottbus
- Universitätsklinikum Halle (Saale) — Halle
Identifiers
NCT: NCT06570902 · 90D0270