NCT06641362 Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
| NCT ID | NCT06641362 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VDI Technologies |
| Condition | Bradycardia |
| Study Type | OBSERVATIONAL |
| Enrollment | 360 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 360 participants in total. It began in 2025-03-18 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06641362 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bradycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06641362 currently recruiting?
Yes, NCT06641362 is actively recruiting participants. Contact the research team at randy.labounty@vdimaging.com for enrollment information.
Where is the NCT06641362 trial being conducted?
This trial is being conducted at Avondale, United States, Mesa, United States, Chicago, United States, Rochester, United States and 8 additional locations.
Who is sponsoring the NCT06641362 clinical trial?
NCT06641362 is sponsored by VDI Technologies. The trial plans to enroll 360 participants.