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

Официальное название

Pivotal Clinical Study of VDI's Ultra-High Frequency Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED): THE SYNC Study

Обзор

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.

Вмешательства

• Устройство Ultra High Frequency Electrocardiogram (UHF-ECG)
  Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.

Первичные конечные точки

• Predictive agreement between UHF-ECG and standard ECG [Срок оценки: Pre-procedure]

Вторичные конечные точки (1)

• Predictive agreement in dyssynchrony between UHF-ECG and standard ECG [Срок оценки: Pre-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 7 центров

• Peak Heart and Vascular — Avondale
• Banner Medical Center — Mesa
• University of Chicago — Chicago
• Mayo Clinic — Rochester
• Ohio State University — Columbus
• Baylor College of Medicine — Houston
• University of Virginia — Charlottesville

Чехия · 4 центра

• Fakultní nemocnice Brno — Brno
• St. Anne's University Hospital — Brno
• Na Homolce Hospital — Prague
• Fakultni Nemocnice Královské Vinohrady — Prague

Нидерланды · 1 центр

• Catherina Ziekenhuis — Eindhoven

Публикации

• 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). PMID 29700054
• 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. PMID 34075135

Идентификаторы

NCT: NCT06641362 · CLIN001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗