Prospective WCD Post CABG Registry (CABG Registry)
1 other identifier
observational
910
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2024
CompletedFirst Posted
Study publicly available on registry
August 26, 2024
CompletedStudy Start
First participant enrolled
September 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
November 4, 2024
October 1, 2024
5.1 years
July 28, 2024
October 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
EF recovery
EF recovery at end of WCD use, usually after 90days of wear. End of WCD use will be determined by the prescribing physician. For this study, EF\>35% will be considered as EF recovery.
Enrollment till WCD End of Use
Secondary Outcomes (4)
Quality of Life (KCCQ
Enrollment till WCD End of Use, usually up to three month
Quality of Life EQ
Enrollment till WCD End of Use, usually up to three month
Medication Adherence
Enrollment till WCD End of Use, usually up to three month
Healthcare utilization
Enrollment till WCD End of Use, usually up to three month
Interventions
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
Eligibility Criteria
Patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Kerckhoff Klinik
Bad Nauheim, Hesse, 61231, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Sana-Herzzentrum Cottbus GmbH
Cottbus, 03048, Germany
Universitätsklinikum Halle (Saale)
Halle, 06120, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2024
First Posted
August 26, 2024
Study Start
September 23, 2024
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
May 1, 2030
Last Updated
November 4, 2024
Record last verified: 2024-10