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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Predictive agreement between UHF-ECG and standard ECG [Time frame: Pre-procedure]

Secondary outcome measures (1)

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

United States · 7 centers

• 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

Czechia · 4 centers

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

Netherlands · 1 center

• Catherina Ziekenhuis — Eindhoven

Publications

• 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

Identifiers

NCT: NCT06641362 · CLIN001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗