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

NCT04908033 | Active Not Recruiting

• 1 other identifier: EK-VP1421012
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

RV Pacing; Negative Remodeling; Dyssynchrony; UHF-ECG; Physiological Pacing

Keywords

myocardial pacing; physiological pacing; negative remodeling; dyssynchrony; ultra-high-frequency ECG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• RV myocardial to physiological pacing comparison

  2 years from randomization

• UHF-ECG prediction of clinical outcome

  3 years from randomization

Study Arms (2)

myocardial pacing group

patients with the pacing lead placed into the right ventricle to obtain myocardial capture

Device: pacemaker implantation

physiological pacing group

patients with the pacing lead placed into the His bundle or left bundle branch area

Device: pacemaker implantation

Interventions

pacemaker implantation DEVICE

pacemaker implantation

myocardial pacing group; physiological pacing group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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,
• a good quality of images during echocardiography,
• willingness to attend clinical check-ups in the implanting center for at least two years.
• life expectancy of at least 2 years

You may not qualify if:

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

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead
• St. Anne's University Hospital Brno, Czech Republic: collaborator
• Regional Hospital Liberec: collaborator

Study Sites (1)

Karol Curila

Prague, 10000, Czechia

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 15, 2021
• First Posted: June 1, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2024-03

Locations

CZ (1)