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

Bradyarrhythmia Clinical Trial

Official title:

Mechanical and Electrical Dyssynchrony During His-Bundle Pacing (Selective and Non-selective) Versus His-Bundle Area Right Ventricular Pacing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04697797
• Other study ID #: RNN/147/20/KE
• Status: Recruiting
• Start date: December 14, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Medical University of Lodz
• Contact: Krzysztof A Kaczmarek, MD, PhD
• Phone: +48 42 201 43 60
• Email: krzysztof.kaczmarek[@]umed.lodz.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bradyarrhythmia
• Bradycardia

Intervention

Other:
• Device Programming
Intervention includes (1) pacemaker reprogramming (2) echocardiographic parameters acquisition (3) ECG recording

Locations

Country	Name	City	State
Poland	Department of Electrocardiology Medical University of Lodz	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interventricular mechanical delay	InterVentricular Mechanical Dyssynchrony Parameter 1	Mid-term: 3-6 months after pacemaker implantation
Primary	Interventricular mechanical delay	InterVentricular Mechanical Dyssynchrony Parameter 1	Long term: 12-15 months after pacemaker implantation
Primary	Free-wall-LV-to-RV-delay	InterVentricular Mechanical Dyssynchrony Parameter 2	Mid-term: 3-6 months after pacemaker implantation
Primary	Free-wall-LV-to-RV-delay	InterVentricular Mechanical Dyssynchrony Parameter 2	Long term: 12-15 months after pacemaker implantation
Primary	Septal-to-posterior wall motion delay	IntraVentricular Mechanical Dyssynchrony Parameter 1	Mid-term: 3-6 months after pacemaker implantation
Primary	Septal-to-posterior wall motion delay	IntraVentricular Mechanical Dyssynchrony Parameter 1	Long term: 12-15 months after pacemaker implantation
Primary	Opposing wall motion delay	IntraVentricular Mechanical Dyssynchrony Parameter 2	Long term: 12-15 months after pacemaker implantation
Primary	Opposing wall motion delay	IntraVentricular Mechanical Dyssynchrony Parameter 2	Mid-term: 3-6 months after pacemaker implantation
Primary	systolic dyssynchrony index	Ventricular Mechanical Dyssynchrony Parameter 1	Long term: 12-15 months after pacemaker implantation
Primary	systolic dyssynchrony index	Ventricular Mechanical Dyssynchrony Parameter 1	Mid-term: 3-6 months after pacemaker implantation
Primary	QRS duration	Electrical dyssynchrony Parameter	Mid-term: 3-6 months after pacemaker implantation
Primary	QRS duration	Electrical dyssynchrony Parameter	Long term: 12-15 months after pacemaker implantation
Secondary	Radial strain	Additional Ventricular Mechanical Dyssynchrony Parameter 1	Mid-term: 3-6 months after pacemaker implantation
Secondary	Radial strain	Additional Ventricular Mechanical Dyssynchrony Parameter 1	Long term: 12-15 months after pacemaker implantation
Secondary	Left Ventricular Ejection Fraction	Global left ventricle function parameter	Mid-term: 3-6 months after pacemaker implantation
Secondary	Left Ventricular Ejection Fraction	Global left ventricle function parameter	Long term: 12-15 months after pacemaker implantation
Secondary	Global longitudinal strain	Global left ventricle function parameter 2	Mid-term: 3-6 months after pacemaker implantation
Secondary	Global longitudinal strain	Global left ventricle function parameter 2	Long term: 12-15 months after pacemaker implantation
Secondary	Left ventricular output track velocity-time integral	Global left ventricle function parameter 3	Mid-term: 3-6 months after pacemaker implantation
Secondary	Left ventricular output track velocity-time integral	Global left ventricle function parameter 3	Long term: 12-15 months after pacemaker implantation
Secondary	Diastolic Filling Time	Atrioventricular Dyssynchrony Parameter	Mid-term: 3-6 months after pacemaker implantation
Secondary	Diastolic Filling Time	Atrioventricular Dyssynchrony Parameter	Long term: 12-15 months after pacemaker implantation