Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)

Part of paid clinical trials in Avondale, Arizona.

Sponsor
VDI Technologies
Study ID
NCT06641362
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultra High Frequency Electrocardiogram (UHF-ECG) — DEVICE
    Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.

Study Details

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.

Key Dates

Start date
Mar 18, 2025
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
360 participants (estimated)

Arms

  • Arm: Treatment Group
    Participant controlled with standard ECG measurement and VDI UHF-ECG measurement both taken sequentially.

Primary Outcome Measure

Predictive agreement between UHF-ECG and standard ECG [ Time Frame: Pre-procedure ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Peak Heart and VascularAvondaleArizona85392
Tasha Marriott
[email protected]
602-730-9500
Andy Tran, MD (PRINCIPAL_INVESTIGATOR)
Banner Medical CenterMesaArizona85202
Dalise Dai
Roderick Tung, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Kie Ng
[email protected]
773-702-1015
Gaurav Upadhyay, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Brent Quam
[email protected]
507-422-3235
Yong-Mei Cha, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Adrianne Miller
Shrinivas Hebsur, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Stephen Harold
Michael Chelu, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22908
Cathy Roy
Kenneth Bilchick, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Avondale, AZ

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Peak Heart and Vascular· Avondale, AZBanner Medical Center· Mesa, AZUniversity of Chicago· Chicago, ILMayo Clinic· Rochester, MNOhio State University· Columbus, OHBaylor College of Medicine· Houston, TX

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