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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Participant controlled with standard ECG measurement and VDI UHF-ECG measurement both taken sequentially. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra High Frequency Electrocardiogram (UHF-ECG) | Device | Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure. |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive agreement between UHF-ECG and standard ECG | 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. | Pre-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive agreement in dyssynchrony between UHF-ECG and standard ECG | Predictive agreement of ventricular dyssynchrony and sidedness on the pre-procedure 12-lead ECG compared of UHF-ECG in participants with identified ventricular dyssynchrony. | Pre-procedure |
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Inclusion Criteria:
Exclusion Criteria:
Different QRS duration requirements for male and female.
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Participants who are eligible for this study must have bradycardia or heart failure and are scheduled for pacemaker device implantation. Baseline ECG requirements must be met.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Randy LaBounty | Contact | 9529136050 | randy.labounty@vdimaging.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peak Heart and Vascular | Recruiting | Avondale | Arizona | 85392 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29700054 | Background | Plesinger F, Jurak P, Halamek J, Nejedly P, Leinveber P, Viscor I, Vondra V, McNitt S, Polonsky B, Moss AJ, Zareba W, Couderc JP. Ventricular Electrical Delay Measured From Body Surface ECGs Is Associated With Cardiac Resynchronization Therapy Response in Left Bundle Branch Block Patients From the MADIT-CRT Trial (Multicenter Automatic Defibrillator Implantation-Cardiac Resynchronization Therapy). Circ Arrhythm Electrophysiol. 2018 May;11(5):e005719. doi: 10.1161/CIRCEP.117.005719. Epub 2018 Apr 26. | |
| 34075135 |
| Label | URL |
|---|---|
| sponsor website | View source |
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| Banner Medical Center | Recruiting | Mesa | Arizona | 85202 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| Fakultní nemocnice Brno | Recruiting | Brno | 625 00 | Czechia |
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| St. Anne's University Hospital | Recruiting | Brno | 65691 | Czechia |
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| Na Homolce Hospital | Recruiting | Prague | 150 30 | Czechia |
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| Fakultni Nemocnice Královské Vinohrady | Recruiting | Prague | Czechia |
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| Catherina Ziekenhuis | Recruiting | Eindhoven | 5623 | Netherlands |
|
| Background |
| Jurak P, Bear LR, Nguyen UC, Viscor I, Andrla P, Plesinger F, Halamek J, Vondra V, Abell E, Cluitmans MJM, Dubois R, Curila K, Leinveber P, Prinzen FW. 3-Dimensional ventricular electrical activation pattern assessed from a novel high-frequency electrocardiographic imaging technique: principles and clinical importance. Sci Rep. 2021 Jun 1;11(1):11469. doi: 10.1038/s41598-021-90963-4. |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D006333 | Heart Failure |
| D018754 | Ventricular Dysfunction |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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