NCT06641362Recruiting
Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
VDI Technologies
Start Date
3/18/2025
Completion Date
5/1/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DEVICE
Ultra High Frequency Electrocardiogram (UHF-ECG)
Conditions
BradycardiaHeart FailureVentricular Dysfunction
Locations
Peak Heart and Vascular
Avondale, Arizona 85392
United States
Banner Medical Center
Mesa, Arizona 85202
United States
University of Chicago
Chicago, Illinois 60637
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Ohio State University
Columbus, Ohio 43210
United States
Baylor College of Medicine
Houston, Texas 77030
United States
University of Virginia
Charlottesville, Virginia 22908
United States
Fakultní nemocnice Brno
Brno, 625 00
Czechia
St. Anne's University Hospital
Brno, 65691
Czechia
Na Homolce Hospital
Prague, 150 30
Czechia
Fakultni Nemocnice Královské Vinohrady
Prague,
Czechia
Catherina Ziekenhuis
Eindhoven, 5623
Netherlands