The SYNC Study: Pivotal Clinical Study of VDI’s Ultra-High FrequencY Electrocardiogram (UHF-ECG) for the DiagNosis of VentriCular Electrical Dyssynchrony (VED)
The VDI Ultra-High Frequency (UHF) ECG System is intended to aid in the detection of Ventricular Electrical Dyssynchrony (VED) in patients with bradycardia or heart failure.
The purpose of this study is to demonstrate the safety and effectiveness of the VDI UHF- ECG System in the diagnosis of VED when compared to the 12-lead ECG in patients with bradycardia and heart failure indicated for pacemaker implantation.
Sponsor
Study objectives
The study is designed to provide objective, scientific evidence to support marketing clearance/approvals.
Primary endpoints
- Positive and negative predictive agreement between the 12-lead ECG and UHF-ECG in discrimination of ventricular synchrony versus dyssynchrony with one recording per participant taken pre-procedure as evaluated by the core laboratory.
Other Endpoint(s)
- For patients with ventricular dyssynchrony on the pre-procedure
12- lead ECG, comparison of UHF-ECG result categorized as left or right-sided dyssynchrony to the 12-lead ECG to assess predictive agreement of VED.
- The map signal quality parameter Q (signal-to-noise ratio) is ≥ 3 in five or six of the V1 to V6 leads in 90% of the patients at the end of the procedure in a paced rhythm.
For the pre-procedure 12-lead ECG, percent agreement between the core lab assessment and the site investigator assessment of diagnosis for ventricular synchrony versus dyssynchrony
CERC Services
- CoreLab activities
Countries
Number of investigational sites
20 sites in the USA and the EU
