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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
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

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Anne's University Hospital
Coordinator of this site? Confirm its status
BrnoCzechiaRecruiting
Fakultni nemocnice Brno
Coordinator of this site? Confirm its status
BrnoCzechiaRecruiting
Fakultni nemocnice Kralovske Vinohrady
Coordinator of this site? Confirm its status
PragueCzechiaRecruiting
Na Homolce Hospital
Coordinator of this site? Confirm its status
PragueCzechiaRecruiting
Catherina Ziekenhuis
Coordinator of this site? Confirm its status
EindhovenNetherlandsRecruiting
Peak Heart and Vascular
Coordinator of this site? Confirm its status
AvondaleUnited StatesRecruiting
University of Virginia
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesRecruiting
University of Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Ohio State University
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Baylor College of Medicine
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Banner Medical Center
Coordinator of this site? Confirm its status
MesaUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.