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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04697797
Enrollment
100
Registered
2021-01-06
Start date
2020-12-14
Completion date
2022-12-31
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradyarrhythmia

Keywords

His Bundle Pacing, Dyssynchrony, Echocardiography, ECG

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.

Interventions

Intervention includes (1) pacemaker reprogramming (2) echocardiographic parameters acquisition (3) ECG recording

Sponsors

Medical University of Lodz
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
QRS durationMid-term: 3-6 months after pacemaker implantationElectrical dyssynchrony Parameter
Interventricular mechanical delayMid-term: 3-6 months after pacemaker implantationInterVentricular Mechanical Dyssynchrony Parameter 1
Free-wall-LV-to-RV-delayMid-term: 3-6 months after pacemaker implantationInterVentricular Mechanical Dyssynchrony Parameter 2
Septal-to-posterior wall motion delayMid-term: 3-6 months after pacemaker implantationIntraVentricular Mechanical Dyssynchrony Parameter 1
Opposing wall motion delayLong term: 12-15 months after pacemaker implantationIntraVentricular Mechanical Dyssynchrony Parameter 2
systolic dyssynchrony indexLong term: 12-15 months after pacemaker implantationVentricular Mechanical Dyssynchrony Parameter 1

Secondary

MeasureTime frameDescription
Left Ventricular Ejection FractionMid-term: 3-6 months after pacemaker implantationGlobal left ventricle function parameter
Global longitudinal strainMid-term: 3-6 months after pacemaker implantationGlobal left ventricle function parameter 2
Left ventricular output track velocity-time integralMid-term: 3-6 months after pacemaker implantationGlobal left ventricle function parameter 3
Diastolic Filling TimeMid-term: 3-6 months after pacemaker implantationAtrioventricular Dyssynchrony Parameter
Radial strainMid-term: 3-6 months after pacemaker implantationAdditional Ventricular Mechanical Dyssynchrony Parameter 1

Countries

Poland

Contacts

Primary ContactKrzysztof A Kaczmarek, MD, PhD
krzysztof.kaczmarek@umed.lodz.pl+48 42 201 43 60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026