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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04697797
Other study ID # RNN/147/20/KE
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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