Clinical trial NCT06641362: Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
Official title: Pivotal Clinical Study of VDI's Ultra-High Frequency Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED): THE SYNC Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bradycardia
Heart Failure
Ventricular Dysfunction
Lead sponsor: VDI Technologies
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* Adults with bradycardia scheduled for pacemaker implant or heart failure patients indicated for cardiac resynchronization therapy (CRT) with one of the following:

  * Bradycardia with ventricular synchrony and QRS duration \< 110 ms in men or \< 100 ms in women or;
  * Bradycardia with left bundle branch block and QRS duration \> 140 ms in men or \> 130 ms in women or;
  * Bradycardia with right bundle branch block and QRS duration \> 130 ms in men or \> 120 ms in women or;
  * Heart failure with left bundle branch block and QRS duration \> 140 ms in men or \>130 ms in women.
* 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.

Primary outcomes:
measure: Predictive agreement between UHF-ECG and standard ECG
timeFrame: Pre-procedure
Secondary outcomes:
measure: Predictive agreement in dyssynchrony between UHF-ECG and standard ECG
timeFrame: Pre-procedure
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Medical Center
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Brno
country: Czechia
facility: St. Anne's University Hospital
Study officials:
References:
citation: 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.
citation: 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.