Ultra-high-frequency ECG to diagnose ventricular electrical dyssynchrony in patients getting pacemakers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares a novel ultra-high-frequency electrocardiogram (UHF-ECG) measurement to the standard 12-lead ECG in patients scheduled for first-time pacemaker implantation, including CRT or conduction system pacing. UHF-ECG recordings will be obtained around the time of the implant and analyzed for signs of ventricular electrical dyssynchrony, with results compared against conventional ECG findings. The primary aims are to demonstrate the safety of using the VDI UHF-ECG System in this setting and its diagnostic effectiveness relative to the 12-lead ECG. Data will be collected at several centers, including community and academic sites, to evaluate performance across typical clinical settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peak Heart and Vascular
  Avondale, Arizona, United States Recruiting
• Banner Medical Center
  Mesa, Arizona, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Randy LaBounty
• Email: randy.labounty@vdimaging.com
• Phone: 9529136050

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.