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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and effective the VDI UHF-ECG System is at finding when the heart’s lower chambers beat out of sync. It compares this system with a standard 12-lead ECG, a test of the heart’s electrical signals. It is for adults with a slow heartbeat or heart failure who are scheduled to get their first pacemaker.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a slow heartbeat or heart failure and be scheduled for your first pacemaker, including special types called CRT or CSP.
  • Have one of these heart patterns: a slow heartbeat with lower chambers beating in sync and a QRS of 110 milliseconds or less; a slow heartbeat with a left, right, or other electrical pathway delay that needs treatment; or heart failure with a left electrical pathway delay. QRS measures how long an electrical signal takes to move through the heart’s lower chambers.
  • Understand the study and be willing to follow all study rules.
  • Sign a form agreeing to take part in the study.
  • Have a negative pregnancy test before the procedure if you could become pregnant.

Who can't join

  • Have a complete block of electrical signals between the heart’s upper and lower chambers without a steady backup rhythm, or another condition that prevents measuring the QRS signal.
  • Have or have had an implanted pacemaker or defibrillator, a device that treats dangerous heart rhythms.
  • Have a condition that makes a standard ECG hard to do, such as an allergy to ECG pads, burns, or open wounds.
  • Be in another study of an experimental device or drug that is still in its active treatment phase or would conflict with this study.
  • Have another health condition that could make it hard to take part, follow study rules, or keep the study results reliable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (7)

AZ

IL

MN

OH

  • Ohio State University · Columbus, OH 43210Adrianne Miller · Study contactShrinivas Hebsur, MD · Principal investigatorMore trials in Columbus

TX

  • Baylor College of Medicine · Houston, TX 77030Stephen Harold · Study contactMichael Chelu, MD · Principal investigatorMore trials in Houston

VA

  • University of Virginia · Charlottesville, VA 22908Cathy Roy · Study contactKenneth Bilchick, MD · Principal investigatorMore trials in Charlottesville