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

N/AActive Not RecruitingNCT04908033

Faculty Hospital Kralovske Vinohrady368 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

368

Conditions

RV Pacing Negative Remodeling Dyssynchrony UHF-ECG Physiological Pacing

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 1 year from randomization

Secondary Outcomes

RV myocardial to physiological pacing comparison

left ventricular ejection fraction comparison between low risk right ventricular myocardial to physiological pacing group

Time frame: 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

Time frame: 3 years from randomization