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

Physiological Pacing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908033
• Other study ID #: EK-VP1421012
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: February 2023
• Source: Faculty Hospital Kralovske Vinohrady
• Contact: karol curila
• Phone: 00420777869171
• Email: curilakarol[@]seznam.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Physiological Pacing
• Ventricular Remodeling

Intervention

Device:
• pacemaker implantation
pacemaker implantation

Locations

Country	Name	City	State
Czechia	Karol Curila	Praha 10

Sponsors (3)

Lead Sponsor	Collaborator
Faculty Hospital Kralovske Vinohrady	Regional Hospital Liberec, St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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