Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
NCT06641362 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 360
Last updated 2026-05-05
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.
Conditions
- Bradycardia
- Heart Failure
- Ventricular Dysfunction
Interventions
- DEVICE
-
Ultra High Frequency Electrocardiogram (UHF-ECG)
Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.
Sponsors & Collaborators
-
VDI Technologies
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-18
- Primary Completion
- 2027-03-31
- Completion
- 2027-05-31
- FDA Device
- Yes
Countries
- United States
- Czechia
- Netherlands
Study Locations
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