Observing heart function recovery after bypass surgery with a wearable defibrillator

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medizinische Hochschule Hannover
  Hanover, Lower Saxony, Germany Recruiting
• Sana-Herzzentrum Cottbus GmbH
  Cottbus, Germany Recruiting
• Universitätsklinikum Halle (Saale)
  Halle, Germany Recruiting
• Kerckhoff Klinik
  Bad Nauheim, Hesse, Germany Not yet recruiting

Study contacts

• Study coordinator: Lars Weber, M.Sc.
• Email: lweber@zoll.com
• Phone: 015161140498

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.