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

Recruitingn/aAges 18 Years - anyAllVDI Technologies
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Ultra High Frequency Electrocardiogram (UHF-ECG)
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Where

12 sites
Peak Heart and Vascular
Avondale, United States
Banner Medical Center
Mesa, United States
University of Chicago
Chicago, United States
Mayo Clinic
Rochester, United States
Ohio State University
Columbus, United States
Baylor College of Medicine
Houston, United States
University of Virginia
Charlottesville, United States
Fakultnรญ nemocnice Brno
Brno, Czechia

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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