Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
SYNC
Pivotal Clinical Study of VDI's Ultra-High Frequency Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED): THE SYNC Study
1 other identifier
observational
360
3 countries
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedStudy Start
First participant enrolled
March 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
May 5, 2026
May 1, 2026
2 years
October 11, 2024
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Predictive agreement between UHF-ECG and standard ECG
Positive and negative predictive agreement between standard 12-lead ECG and UHF-ECG in discrimination of ventricular synchrony versus dyssynchrony with one recording per participant taken pre-procedure as evaluated by the core laboratory.
Pre-procedure
Secondary Outcomes (1)
Predictive agreement in dyssynchrony between UHF-ECG and standard ECG
Pre-procedure
Study Arms (1)
Treatment Group
Participant controlled with standard ECG measurement and VDI UHF-ECG measurement both taken sequentially.
Interventions
Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.
Eligibility Criteria
Participants who are eligible for this study must have bradycardia or heart failure and are scheduled for pacemaker device implantation. Baseline ECG requirements must be met.
You may qualify if:
- 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.
You may not qualify if:
- Complete AV block (3rd-degree AV block) without a stable escape rhythm or other circumstances where there is no measurable QRS.
- Subjects with a previous or current pacemaker or defibrillator implant.
- 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.
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VDI Technologieslead
Study Sites (12)
Peak Heart and Vascular
Avondale, Arizona, 85392, United States
Banner Medical Center
Mesa, Arizona, 85202, United States
University of Chicago
Chicago, Illinois, 60637, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Ohio State University
Columbus, Ohio, 43210, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Fakultní nemocnice Brno
Brno, 625 00, Czechia
St. Anne's University Hospital
Brno, 65691, Czechia
Na Homolce Hospital
Prague, 150 30, Czechia
Fakultni Nemocnice Královské Vinohrady
Prague, Czechia
Catherina Ziekenhuis
Eindhoven, 5623, Netherlands
Related Publications (2)
Plesinger F, Jurak P, Halamek J, Nejedly P, Leinveber P, Viscor I, Vondra V, McNitt S, Polonsky B, Moss AJ, Zareba W, Couderc JP. Ventricular Electrical Delay Measured From Body Surface ECGs Is Associated With Cardiac Resynchronization Therapy Response in Left Bundle Branch Block Patients From the MADIT-CRT Trial (Multicenter Automatic Defibrillator Implantation-Cardiac Resynchronization Therapy). Circ Arrhythm Electrophysiol. 2018 May;11(5):e005719. doi: 10.1161/CIRCEP.117.005719. Epub 2018 Apr 26.
PMID: 29700054BACKGROUNDJurak P, Bear LR, Nguyen UC, Viscor I, Andrla P, Plesinger F, Halamek J, Vondra V, Abell E, Cluitmans MJM, Dubois R, Curila K, Leinveber P, Prinzen FW. 3-Dimensional ventricular electrical activation pattern assessed from a novel high-frequency electrocardiographic imaging technique: principles and clinical importance. Sci Rep. 2021 Jun 1;11(1):11469. doi: 10.1038/s41598-021-90963-4.
PMID: 34075135BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2024
First Posted
October 15, 2024
Study Start
March 18, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share