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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Bradycardia; Ventricular Dysfunction
• Intervention / Treatment: Device: Ultra High Frequency Electrocardiogram (UHF-ECG)

• Study Type: Observational
• Enrollment (Estimated): 360

Contacts and Locations

• Study Contact: Name: Randy LaBounty; Phone Number: 9529136050; Email: randy.labounty@vdimaging.com

Study Locations

• Czechia
  • Brno, Czechia, 625 00
    • Recruiting
    • Fakultni nemocnice Brno
    • Principal Investigator: Milan Sepši, MD
  • Brno, Czechia, 65691
    • Recruiting
    • St. Anne's University Hospital
    • Contact: Andrej Nagy, MD
  • Prague, Czechia
    • Recruiting
    • Fakultní Nemocnice Královské Vinohrady
    • Principal Investigator: Petr Štros, MD
  • Prague, Czechia, 150 30
    • Recruiting
    • Na Homolce Hospital
    • Principal Investigator: Milan Chovanec, MD
• Netherlands
  • Eindhoven, Netherlands, 5623
    • Recruiting
    • Catherina Ziekenhuis
    • Principal Investigator: Nars Rademakers, MD
• United States
  • Arizona
    • Avondale, Arizona, United States, 85392
      • Recruiting
      • Peak Heart and Vascular
      • Principal Investigator: Andy Tran, MD
      • Contact: Tasha Marriott; Phone Number: 602-730-9500; Email: tasha.marriott@axsendoclinical.com
    • Mesa, Arizona, United States, 85202
      • Recruiting
      • Banner Medical Center
      • Principal Investigator: Roderick Tung, MD
      • Contact: Dalise Dai
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Principal Investigator: Gaurav Upadhyay, MD
      • Contact: Kie Ng; Phone Number: 773-702-1015; Email: kie@bsd.uchicago.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Yong-Mei Cha, MD
      • Contact: Brent Quam; Phone Number: 507-422-3235; Email: Quam.Brent@mayo.edu
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Principal Investigator: Shrinivas Hebsur, MD
      • Contact: Adrianne Miller
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Stephen Harold
      • Principal Investigator: Michael Chelu, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Principal Investigator: Kenneth Bilchick, MD
      • Contact: Cathy Roy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; Participant controlled with standard ECG measurement and VDI UHF-ECG measurement both taken sequentially.	Device: Ultra High Frequency Electrocardiogram (UHF-ECG); Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.; Other Names: Standard 12 lead Electrocardiogram (ECG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive agreement in dyssynchrony between UHF-ECG and standard ECG	Predictive agreement of ventricular dyssynchrony and sidedness on the pre-procedure 12-lead ECG compared of UHF-ECG in participants with identified ventricular dyssynchrony.	Pre-procedure

Collaborators and Investigators

• Sponsor: VDI Technologies

Publications and helpful links

General Publications

• 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.
• Jurak 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.

Helpful Links

• sponsor website

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Heart Failure; Bradycardia; Ventricular Dysfunction
• Other Study ID Numbers: CLIN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No