NCT06641362Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 360 (estimated)
- First submitted
- 11 Oct 2024
- Start date
- Mar 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- VDI Technologies
- Diseases
- Heart failure
- NCT number
- NCT06641362
What you commit to
- Study type: Observational
- Planned participants: 360
- From Mar 2025 to the primary completion date, Mar 2027
- 12 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with a previous or current pacemaker or defibrillator implant.
- 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 illness
- 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.
- 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.
Other
- Complete AV block (3rd-degree AV block) without a stable escape rhythm or other circumstances where there is no measurable QRS.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Anne's University Hospital Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Na Homolce Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Catherina Ziekenhuis Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Peak Heart and Vascular Coordinator of this site? Confirm its status | Avondale | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Banner Medical Center Coordinator of this site? Confirm its status | Mesa | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.