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.
Study Type
OBSERVATIONAL
Enrollment
360
Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.
Peak Heart and Vascular
Avondale, Arizona, United States
RECRUITINGBanner Medical Center
Mesa, Arizona, United States
RECRUITINGPredictive agreement between UHF-ECG and standard ECG
Positive and negative predictive agreement between standard 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.
Time frame: Pre-procedure
Predictive agreement in dyssynchrony between UHF-ECG and standard ECG
Predictive agreement of ventricular dyssynchrony and sidedness on the pre-procedure 12-lead ECG compared of UHF-ECG in participants with identified ventricular dyssynchrony.
Time frame: Pre-procedure
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University of Chicago
Chicago, Illinois, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGUniversity of Virginia
Charlottesville, Virginia, United States
RECRUITINGFakultní nemocnice Brno
Brno, Czechia
RECRUITINGSt. Anne's University Hospital
Brno, Czechia
RECRUITINGNa Homolce Hospital
Prague, Czechia
RECRUITING...and 2 more locations