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

• Conditions: Bradycardia; Heart Failure; Ventricular Dysfunction

• Registration Number: NCT06641362
• Lead Sponsor: VDI Technologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-15
• Status Verified: 2025-03
• Study Start: 2025-03-18
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive agreement between UHF-ECG and standard ECG	Pre-procedure	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.

Secondary Outcome Measures

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

Trial Locations

Locations (6)

St. Anne's University Hospital; 🇨🇿 Brno, Czechia

Banner Medical Center; 🇺🇸 Mesa, Arizona, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States