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

Ultra-high-frequency ECG for Prediction of Adverse Left Ventricular Remodeling in Permanent Right Ventricular Pacing

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physiological Pacing; RV Pacing; Negative Remodeling; Dyssynchrony; UHF-ECG
• Intervention / Treatment: Device: pacemaker implantation

• Study Type: Observational
• Enrollment (Actual): 368

Contacts and Locations

Study Locations

• Czechia
  • Praha 10, Czechia, 10000
    • Karol Curila

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

360 patients with an indication for permanent pacing due to permanent conduction disease of/below the AV node

Description

Inclusion Criteria:

1. expectation of permanent right ventricular pacing with atrio-ventricular delay set to 150/180 ms (130/160 resp.) for sensed/paced atrial events during a follow-up,
2. a good quality of images during echocardiography,
3. willingness to attend clinical check-ups in the implanting center for at least two years.
4. life expectancy of at least 2 years

Exclusion Criteria:

1. planned cardiac surgery or transcatheter aortic valve implantation
2. hypertrophic cardiomyopathy
3. an indication for implantable cardioverter-defibrillator, biventricular implantable cardioverter-defibrillator, or biventricular pacemaker
4. active myocarditis
5. cardiac surgery or coronary revascularization in the last ten days
6. persistent/permanent atrial fibrillation during randomization
7. severe aortic stenosis
8. mitral valvular disease with an indication to intervention.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
myocardial pacing group; patients with the pacing lead placed into the right ventricle to obtain myocardial capture	Device: pacemaker implantation; pacemaker implantation
physiological pacing group; patients with the pacing lead placed into the His bundle or left bundle branch area	Device: pacemaker implantation; pacemaker implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
negative remodeling prediction	5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG electrical dyssynchrony parameter; 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG left ventricular lateral wall delay parameter; 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG V6d parameter; 10% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG left ventricular lateral wall delay parameter; 10% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG V6d parameter	1 year from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RV myocardial to physiological pacing comparison	left ventricular ejection fraction comparison between low risk right ventricular myocardial to physiological pacing group	2 years from randomization
UHF-ECG prediction of clinical outcome	occurence of death, myocardial infarction, worsening heart failure or upgrade to resynchronization therapy will be predicted by the duration of UHF-ECG electrical dyssynchrony, and/or left ventricular lateral wall delay and/or V6d parameter	3 years from randomization

Collaborators and Investigators

• Sponsor: Faculty Hospital Kralovske Vinohrady
• Collaborators: St. Anne's University Hospital Brno, Czech Republic; Regional Hospital Liberec

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 15, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: physiological pacing; dyssynchrony; myocardial pacing; negative remodeling; ultra-high-frequency ECG
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Ventricular Remodeling
• Other Study ID Numbers: EK-VP1421012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No