Actively Recruiting
Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
Led by VDI Technologies · Updated on 2026-05-05
360
Participants Needed
12
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Peak Heart and Vascular
Avondale, Arizona, United States, 85392
Actively Recruiting
2
Banner Medical Center
Mesa, Arizona, United States, 85202
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
6
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
7
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
8
Fakultní nemocnice Brno
Brno, Czechia, 625 00
Actively Recruiting
9
St. Anne's University Hospital
Brno, Czechia, 65691
Actively Recruiting
10
Na Homolce Hospital
Prague, Czechia, 150 30
Actively Recruiting
11
Fakultni Nemocnice Královské Vinohrady
Prague, Czechia
Actively Recruiting
12
Catherina Ziekenhuis
Eindhoven, Netherlands, 5623
Actively Recruiting
Research Team
R
Randy LaBounty
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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