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NCT04908033

Ultra-high-frequency ECG for Prediction of Left Ventricular Remodeling

Status unknown Last updated 5 March 2025
What this trial tests

trial testing pacemaker implantation in RV Pacing in 368 participants. Status unknown.

Timeline
1 May 2021
Primary endpoint
1 June 2025
1 December 2025

Quick facts

Lead sponsorFaculty Hospital Kralovske Vinohrady
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment368
Start date1 May 2021
Primary completion1 June 2025
Estimated completion1 December 2025
Sites1 location across Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Faculty Hospital Kralovske Vinohrady

Who can join

18 and older, any sex, with RV Pacing or Negative Remodeling. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main goal of the project is to prove that ultra-high-frequency ECG (UHF-ECG) can be used as a diagnostic tool that allows the prediction of patients susceptible to the negative effect of right ventricular myocardial pacing. The prediction will be based on the assessment of electrical dyssynchrony and local depolarization durations of left ventricular depolarization emerging during right ventricular pacing. If proved to be valid in left ventricular negative remodeling prediction, UHF-ECG-derived parameters of ventricular dyssynchrony could be used as markers allowing a lead placement optimization during an implant procedure. This information can help the operator to identify patients with the urgent need for physiological pacing (HB or LBBp) and patients in which a right ventricular myocardial pacing is sufficient and will not lead to the development of the negative left ventricular remodeling.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Ventricular Dyssynchrony and Pacing-induced Cardiomyopathy in Patients with Pacemakers, the Utility of Ultra-high-frequency ECG and Other Dyssynchrony Assessment Tools.
    Mizner J, Jurak P, Linkova H, Smisek R, et al · · 2022 · cited 12× · PMID 35990106 · DOI 10.15420/aer.2022.01

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Other trials of pacemaker implantation

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