Mechanical and Electrical Dyssynchrony During His-Bundle Pacing Versus His-Bundle Area Right Ventricular Pacing

Recruiting

• Conditions: Bradyarrhythmia

• Registration Number: NCT04697797
• Lead Sponsor: Medical University of Lodz

Brief Summary

The aim of this study is to evaluate mechanical and electrical cardiac dyssynchrony in patients with pacemakers and the right ventricular electrode implanted in His Bundle area.

Detailed Description

Permanent His Bundle Pacing (HBP) is a well-known method of cardiac pacing which is increasingly used in everyday practice. After lead implantation in His Bundle area (HBA) capture of various tissues can be achieved: A. right ventricular myocardium near to HBP; B. cardiac conduction system selectively or nonselectively (with concomitant regional myocardium activation). The different excitability and refractory periods decide which tissue, myocardium or/and the conduction system is effectively paced. A lot of clinical trials revealed the advantage of HBP over apical ventricular pacing (AVP). HBP improves clinical (NYHA, quality of life, hospitalization rate) and echocardiographic (left ventricular dimension and ejection fraction) indicators of heart failure.

We are going to compare mechanical and electrical synchrony during the various type of myocardium activation: HBP (nsHBP or sHBP), RV pacing near HBA and native heart rhythm (if possible) in each patient recruited to the study. Adequate pacemaker programming will allow achieving different activations as shown above. The mechanical synchrony will be estimated by transthoracic echocardiography and the electrical one by the detailed analysis of ECG.

Study Timeline

• Study Start: 2020-12-14
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Primary Completion: 2022-10-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• all adult patients after implantation of pacemaker system with pacing lead successfully captured His Bundle (selectively or/and nonselectively)

Exclusion Criteria

• not willing or incapable to give written informed consent;
• previous implanted cardiac electronic device (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interventricular mechanical delay	Long term: 12-15 months after pacemaker implantation	InterVentricular Mechanical Dyssynchrony Parameter 1
Free-wall-LV-to-RV-delay	Long term: 12-15 months after pacemaker implantation	InterVentricular Mechanical Dyssynchrony Parameter 2
systolic dyssynchrony index	Mid-term: 3-6 months after pacemaker implantation	Ventricular Mechanical Dyssynchrony Parameter 1
Septal-to-posterior wall motion delay	Long term: 12-15 months after pacemaker implantation	IntraVentricular Mechanical Dyssynchrony Parameter 1
Opposing wall motion delay	Mid-term: 3-6 months after pacemaker implantation	IntraVentricular Mechanical Dyssynchrony Parameter 2
QRS duration	Long term: 12-15 months after pacemaker implantation	Electrical dyssynchrony Parameter

Secondary Outcome Measures

Name	Time	Method
Radial strain	Long term: 12-15 months after pacemaker implantation	Additional Ventricular Mechanical Dyssynchrony Parameter 1
Global longitudinal strain	Long term: 12-15 months after pacemaker implantation	Global left ventricle function parameter 2
Left Ventricular Ejection Fraction	Long term: 12-15 months after pacemaker implantation	Global left ventricle function parameter
Left ventricular output track velocity-time integral	Long term: 12-15 months after pacemaker implantation	Global left ventricle function parameter 3
Diastolic Filling Time	Long term: 12-15 months after pacemaker implantation	Atrioventricular Dyssynchrony Parameter

Trial Locations

Locations (1)

Department of Electrocardiology Medical University of Lodz; 🇵🇱 Lodz, Poland