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

Active, not recruiting

• Conditions: Dyssynchrony; UHF-ECG; RV Pacing; Negative Remodeling; Physiological Pacing
• Interventions: Device: pacemaker implantation

• Registration Number: NCT04908033
• Lead Sponsor: Faculty Hospital Kralovske Vinohrady

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-05-15
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 368

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
physiological pacing group	pacemaker implantation	patients with the pacing lead placed into the His bundle or left bundle branch area
myocardial pacing group	pacemaker implantation	patients with the pacing lead placed into the right ventricle to obtain myocardial capture

Primary Outcome Measures

Name	Time	Method
negative remodeling prediction	1 year from randomization	* 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

Secondary Outcome Measures

Name	Time	Method
RV myocardial to physiological pacing comparison	2 years from randomization	left ventricular ejection fraction comparison between low risk right ventricular myocardial to physiological pacing group
UHF-ECG prediction of clinical outcome	3 years from randomization	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

Trial Locations

Locations (1)

Karol Curila; 🇨🇿 Praha 10, Czechia