Tests a new heart rhythm device for uneven heart pumping timing
Compares a new ECG device with standard 12-lead ECG in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
Key facts
- Where
- Eindhoven, NetherlandsSee the site
Where in Netherlands
- Catherina ZiekenhuisEindhoven, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- VDI Technologies
- Trial code
- NCT06641362
- Record updated
- 5 May 2026
- Original description
The purpose of this study is to demonstrate the safety and effectiveness of the VDI UHF-ECG System in the diagnosis of ventricular dyssynchrony when compared to the 12-lead ECG in patients with bradycardia and heart failure indicated for pacemaker implantation.Read full original descriptionShow less
Pivotal Clinical Study of VDI's Ultra-High Frequency Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED): THE SYNC Study
The purpose of this study is to demonstrate the safety and effectiveness of the VDI UHF-ECG System in the diagnosis of ventricular dyssynchrony when compared to the 12-lead ECG in patients with bradycardia and heart failure indicated for pacemaker implantation.
Inclusion: Adults with bradycardia or heart failure scheduled for first time pacemaker implant (including CRT/CSP) with one of the following: Bradycardia with ventricular synchrony and QRS duration <= 110 ms, Bradycardia with LBBB, Bradycardia with RBBB, Bradycardia with other IVCD necessitating intervention, or Heart failure with LBBB; Understands the nature of the study and is willing to comply with all study requirements; Provides written informed consent; A negative pregnancy test prior to the procedure for participants of child-bearing potential.
Exclusion: Subjects with a previous or current pacemaker or defibrillator implant; Currently enrolled in another investigational device or drug trial that has not completed the active treatment phase and/or would conflict with this study; Anatomical or other conditions that may make a 12-lead ECG difficult to obtain, such as an allergy to components of the ECG pads, burns, open wounds, etc; Other co-morbid condition(s) that could limit the participant's ability to participate in the study or to comply with study requirements or impact the scientific integrity of the study; Complete AV block (3rd-degree AV block) without a stable escape rhythm or other circumstances where there is no measurable QRS.