Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
Recruiting · NCT06641362 · Observational (researchers observe without assigning treatment) · Lead sponsor: VDI Technologies
View the official record on ClinicalTrials.gov →Interventions studied
Ultra High Frequency Electrocardiogram (UHF-ECG)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- Complete AV block (3rd-degree AV block) without a stable escape rhythm or other circumstances where there is no measurable QRS.
- Subjects with a previous or current pacemaker or defibrillator implant.
- 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.
- Currently enrolled in another investigational device or drug trial that has not completed the active treatment phase and/or would conflict with this study.
- 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.
Where it is running
12 locations listed across 6 US states.
- Peak Heart and Vascular - Avondale, Arizona, United States
- Banner Medical Center - Mesa, Arizona, United States
- University of Chicago - Chicago, Illinois, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Ohio State University - Columbus, Ohio, United States
- Baylor College of Medicine - Houston, Texas, United States
- University of Virginia - Charlottesville, Virginia, United States
- Fakultní nemocnice Brno - Brno, Czechia
- St. Anne's University Hospital - Brno, Czechia
- Catherina Ziekenhuis - Eindhoven, Netherlands
- Na Homolce Hospital - Prague, Czechia
- Fakultni Nemocnice Královské Vinohrady - Prague, Czechia