Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED) (SYNC)

VDI Technologies

Status

Enrolling

Conditions

Bradycardia

Ventricular Dysfunction

Heart Failure

Treatments

Device: Ultra High Frequency Electrocardiogram (UHF-ECG)

Study type

Observational

Funder types

Industry

Identifiers

NCT06641362

CLIN001

Details and patient eligibility

About

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.

Enrollment

360 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.