Clinical trial NCT06570902: Prospective WCD Post CABG Registry (CABG Registry)
Official title: Prospective WCD Post CABG Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiomyopathy Ischemic
Cardiomyopathies
Cardiovascular Diseases
Heart Disease, Ischemic
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 910
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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%.

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.

Primary outcomes:
measure: EF recovery
timeFrame: Enrollment till WCD End of Use
Secondary outcomes:
measure: Quality of Life (KCCQ
timeFrame: Enrollment till WCD End of Use, usually up to three month
measure: Quality of Life EQ
timeFrame: Enrollment till WCD End of Use, usually up to three month
measure: Medication Adherence
timeFrame: Enrollment till WCD End of Use, usually up to three month
measure: Healthcare utilization
timeFrame: Enrollment till WCD End of Use, usually up to three month
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Cottbus
country: Germany
facility: Sana-Herzzentrum Cottbus GmbH
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
Study officials:
References: