Observing heart function recovery after bypass surgery with a wearable defibrillator
Prospective WCD Post CABG Registry
This study is testing if using a wearable defibrillator after heart bypass surgery can help patients with weak heart function recover better than before.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 910 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zoll Medical Corporation Industry-sponsored |
| Locations | 4 sites (Bad Nauheim, Hesse and 3 other locations) |
| Trial ID | NCT06570902 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the recovery rate of ventricular function in patients with ischemic heart failure who have undergone their first coronary artery bypass graft (CABG) surgery. Participants will be monitored while using a wearable cardioverter defibrillator (WCD) post-surgery, with the expectation that the use of guideline-directed medical therapy (GDMT) will enhance recovery outcomes. The study will focus on patients with reduced ejection fraction (EF ≤35%) and will adjust recruitment to ensure 20% female enrollment. The goal is to determine if more patients achieve an EF recovery compared to previous retrospective data.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone their first CABG surgery within the last 10 days and have reduced ejection fraction.
Not a fit: Patients with prior CABG surgery, those with active unipolar pacemakers, or those with conditions preventing proper interaction with the WCD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery rates of heart function in patients after CABG surgery.
How similar studies have performed: Previous studies have shown a recovery rate of 54% in similar patient populations, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bad Nauheim, Hesse and 3 other locations
- Kerckhoff Klinik — Bad Nauheim, Hesse, Germany (Not_yet_recruiting)
- Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany (Recruiting)
- Sana-Herzzentrum Cottbus GmbH — Cottbus, Germany (Recruiting)
- Universitätsklinikum Halle (Saale) — Halle, Germany (Recruiting)
Study contacts
- Study coordinator: Lars Weber, M.Sc.
- Email: lweber@zoll.com
- Phone: 015161140498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.