Trials / Recruiting
RecruitingNCT06641362
Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
Pivotal Clinical Study of VDI's Ultra-High Frequency Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED): THE SYNC Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 360 (estimated)
- Sponsor
- VDI Technologies · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ultra High Frequency Electrocardiogram (UHF-ECG) | Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure. |
Timeline
- Start date
- 2025-03-18
- Primary completion
- 2026-03-01
- Completion
- 2026-05-01
- First posted
- 2024-10-15
- Last updated
- 2025-09-04
Locations
9 sites across 3 countries: United States, Czechia, Netherlands
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06641362. Inclusion in this directory is not an endorsement.