Dyssynchrony, Negative Remodeling, Physiological Pacing, RV Pacing, UHF-ECG
Conditions
Keywords
myocardial pacing, physiological pacing, negative remodeling, dyssynchrony, ultra-high-frequency ECG
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.
Interventions
DEVICEpacemaker implantation
pacemaker implantation
Sponsors
St. Anne's University Hospital Brno, Czech Republic
Regional Hospital Liberec
Faculty Hospital Kralovske Vinohrady
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Czechia
Outcome results
None listed