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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bradyarrhythmia
• Intervention / Treatment: Other: Device Programming

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Krzysztof A Kaczmarek, MD, PhD; Phone Number: +48 42 201 43 60; Email: krzysztof.kaczmarek@umed.lodz.pl

Study Locations

• Poland
  • Lodz, Poland, 93-216
    • Recruiting
    • Department of Electrocardiology Medical University of Lodz
    • Contact: Krzysztof A Kaczmarek, MD, PhD; Phone Number: +48 42 201 43 60; Email: krzysztof.kaczmarek@umed.lodz.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with bradyarrhythmia and indications for de novo permanent pacemaker implantation. The decision for pacing lead placement in His Bundle is left for physician discretion. Patients after pacemaker system implantation with His Bundle successfully pacing are to be asked to participate in the study. After having written informed consent obtained patients are to be scheduled for ventricular synchrony evaluation with ECHO and ECG after 3-6 months after implant (mid-term) and after 12 months (long-term).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial strain	Additional Ventricular Mechanical Dyssynchrony Parameter 1	Mid-term: 3-6 months after pacemaker implantation
Radial strain	Additional Ventricular Mechanical Dyssynchrony Parameter 1	Long term: 12-15 months after pacemaker implantation
Left Ventricular Ejection Fraction	Global left ventricle function parameter	Mid-term: 3-6 months after pacemaker implantation
Left Ventricular Ejection Fraction	Global left ventricle function parameter	Long term: 12-15 months after pacemaker implantation
Global longitudinal strain	Global left ventricle function parameter 2	Mid-term: 3-6 months after pacemaker implantation
Global longitudinal strain	Global left ventricle function parameter 2	Long term: 12-15 months after pacemaker implantation
Left ventricular output track velocity-time integral	Global left ventricle function parameter 3	Mid-term: 3-6 months after pacemaker implantation
Left ventricular output track velocity-time integral	Global left ventricle function parameter 3	Long term: 12-15 months after pacemaker implantation
Diastolic Filling Time	Atrioventricular Dyssynchrony Parameter	Mid-term: 3-6 months after pacemaker implantation
Diastolic Filling Time	Atrioventricular Dyssynchrony Parameter	Long term: 12-15 months after pacemaker implantation

Collaborators and Investigators

• Sponsor: Medical University of Lodz

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2020
• Primary Completion (ANTICIPATED): October 30, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (ACTUAL): January 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Echocardiography; ECG; Dyssynchrony; His Bundle Pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: RNN/147/20/KE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No