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

Study Overview
=================
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.

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

Conditions
-----------------
Dyssynchrony, UHF-ECG, RV Pacing, Negative Remodeling, Physiological Pacing

Intervention / Treatment
-----------------
* Device: pacemaker implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| myocardial pacing group<br>patients with the pacing lead placed into the right ventricle to obtain myocardial capture | Device: pacemaker implantation<br>* pacemaker implantation<br>|
| physiological pacing group<br>patients with the pacing lead placed into the His bundle or left bundle branch area | Device: pacemaker implantation<br>* pacemaker implantation<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial pacing, physiological pacing, dyssynchrony, ultra-high-frequency ECG, negative remodeling