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

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ClinicalTrials.gov Identifier: NCT04697797
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
Medical University of Lodz

Study Description
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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.

Condition or disease Intervention/treatment
Bradyarrhythmia 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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mechanical and Electrical Dyssynchrony During His-Bundle Pacing (Selective and Non-selective) Versus His-Bundle Area Right Ventricular Pacing
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022
Groups and Cohorts
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Intervention Details:
  • Other: Device Programming
    Intervention includes (1) pacemaker reprogramming (2) echocardiographic parameters acquisition (3) ECG recording
    Other Names:
    • Echocardiography
    • ECG

Outcome Measures
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Primary Outcome Measures :
  1. Interventricular mechanical delay [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    InterVentricular Mechanical Dyssynchrony Parameter 1

  2. Interventricular mechanical delay [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    InterVentricular Mechanical Dyssynchrony Parameter 1

  3. Free-wall-LV-to-RV-delay [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    InterVentricular Mechanical Dyssynchrony Parameter 2

  4. Free-wall-LV-to-RV-delay [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    InterVentricular Mechanical Dyssynchrony Parameter 2

  5. Septal-to-posterior wall motion delay [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    IntraVentricular Mechanical Dyssynchrony Parameter 1

  6. Septal-to-posterior wall motion delay [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    IntraVentricular Mechanical Dyssynchrony Parameter 1

  7. Opposing wall motion delay [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    IntraVentricular Mechanical Dyssynchrony Parameter 2

  8. Opposing wall motion delay [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    IntraVentricular Mechanical Dyssynchrony Parameter 2

  9. systolic dyssynchrony index [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    Ventricular Mechanical Dyssynchrony Parameter 1

  10. systolic dyssynchrony index [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    Ventricular Mechanical Dyssynchrony Parameter 1

  11. QRS duration [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    Electrical dyssynchrony Parameter

  12. QRS duration [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    Electrical dyssynchrony Parameter


Secondary Outcome Measures :
  1. Radial strain [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    Additional Ventricular Mechanical Dyssynchrony Parameter 1

  2. Radial strain [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    Additional Ventricular Mechanical Dyssynchrony Parameter 1

  3. Left Ventricular Ejection Fraction [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    Global left ventricle function parameter

  4. Left Ventricular Ejection Fraction [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    Global left ventricle function parameter

  5. Global longitudinal strain [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    Global left ventricle function parameter 2

  6. Global longitudinal strain [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    Global left ventricle function parameter 2

  7. Left ventricular output track velocity-time integral [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    Global left ventricle function parameter 3

  8. Left ventricular output track velocity-time integral [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    Global left ventricle function parameter 3

  9. Diastolic Filling Time [ Time Frame: Mid-term: 3-6 months after pacemaker implantation ]
    Atrioventricular Dyssynchrony Parameter

  10. Diastolic Filling Time [ Time Frame: Long term: 12-15 months after pacemaker implantation ]
    Atrioventricular Dyssynchrony Parameter


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697797


Contacts
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Contact: Krzysztof A Kaczmarek, MD, PhD +48 42 201 43 60 krzysztof.kaczmarek@umed.lodz.pl

Locations
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Poland
Department of Electrocardiology Medical University of Lodz Recruiting
Lodz, Poland, 93-216
Contact: Krzysztof A Kaczmarek, MD, PhD    +48 42 201 43 60    krzysztof.kaczmarek@umed.lodz.pl   
Sponsors and Collaborators
Medical University of Lodz
More Information
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Responsible Party: Medical University of Lodz
ClinicalTrials.gov Identifier: NCT04697797    
Other Study ID Numbers: RNN/147/20/KE
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Lodz:
His Bundle Pacing
Dyssynchrony
Echocardiography
ECG
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes