Status:
RECRUITING
Prospective WCD Post CABG Registry (CABG Registry)
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Cardiomyopathy Ischemic
Cardiomyopathies
Eligibility:
All Genders
18+ years
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 cardiovert...
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 underg...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 23 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
910 Patients enrolled
Trial Details
Trial ID
NCT06570902
Start Date
September 23 2024
End Date
May 1 2030
Last Update
November 4 2024
Active Locations (4)
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1
Kerckhoff Klinik
Bad Nauheim, Hesse, Germany, 61231
2
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
3
Sana-Herzzentrum Cottbus GmbH
Cottbus, Germany, 03048
4
Universitätsklinikum Halle (Saale)
Halle, Germany, 06120