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
NOT_YET_RECRUITINGBanner Medical Center
Mesa, Arizona, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
Predictive 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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Mayo Clinic
Rochester, Minnesota, United States
NOT_YET_RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGUniversity of Virginia
Charlottesville, Virginia, United States
RECRUITINGSt. Anne's University Hospital
Brno, Czechia
NOT_YET_RECRUITINGCatherina Ziekenhuis
Eindhoven, Netherlands
NOT_YET_RECRUITING