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Completed

NCT Number: NCT05129098

Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block

Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.

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Key information

Conditions

Atrioventricular Nodal Disease

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Patras

Pátrai, Rion, 26504, Greece

About this study

In this prospective, randomized study the outcomes regarding echocardiographic indices of dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients with atrioventricular node disease will be compared In recent years, His pacing has demonstrated better results regarding resynchronization compared to conventional biventricular pacing in trials of 3D mapping. However, technical difficulties that relate to unstable lead positioning or inability in succeeding low pacing threshold have led to low success rates. An alternative site of physiological pacing that could possibly overcome these issues, while maintaining ventricular synchrony is left bundle branch pacing. The lead implantation of LBB pacing is performed using the Select Secure (3830) pacing lead. The lead is screwed into the interventricular septum, until left bundle branch pacing is achieved. The randomized patients 24 hours after the procedure are echocardiographically evaluated and indices of mechanical dyssynchrony are recorded. Follow-up is conducted at 3 months, 6 months and one year post-procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>18 years old
  • Patients with atrioventricular block and EF>50% with a predicted ventricular pacing rate>20%
  • Patients with intraventricular septal diameter>8mm
  • Written informed consent

Exclusion criteria

  • Indication for CRT or ICD device
  • Patients with no subclavian approach, who are candidates for leadless devices
  • Presence of severe tricuspid regurgitation
  • Patients who are candidates for implantation from the right side, as currently the provided tools for left bundle branch pacing fascilitate only left sided pacemaker implantations

Treatment and study plan

Left bundle branch pacing lead (Select Secure 3830 lead)

Device

Implantation of a left bundle branch pacing lead via sheath

Right ventricular active fixation lead

Device

Active fixation lead (standard)

Primary outcomes

  1. Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the global left ventricular work efficiency- as a measure of dyssynchrony- will be recorded.

Secondary outcomes

  1. Procedure Time (min)

    Time frame: 1 Day of procedure

    The total time required for the completion of the procedure

  2. Fluoroscopy Time (min)

    Time frame: 1 Day of procedure

    The total time of fluoroscopy

  3. Dose Area Product (DAP) (cGy/cm2)

    Time frame: 1 Day of procedure

    Total Radiation Dose as expressed with DAP

  4. Implant success

    Time frame: 1 Day of procedure

    Successful implantation with pacing threshold<2 V

  5. Complications associated with pacemaker implantation

    Time frame: through study completion at 1 year post randomisation

    General device related complications: pneumothorax, hemothorax, infection, tamponade, hematoma, lead reoperation Specific complications associated with the left bundle branch pacing procedure: intraventricular septum rupture, septal perforator branch injury with subsequent myocardial infarction or lead displacement

  6. B natriuretic peptide measurement (pg/ml)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Blood samples are extracted in all patients at baseline, 3 months, 6 months and one year after the procedure

  7. Stroke volume index (SVi) (ml/m2)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the SVi will be recorded

  8. Ejection Fraction (EF) (%)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the EF will be recorded

  9. Global Longitudinal Strain (GLS) (%)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the GLS will be recorded

  10. Left Atrium Strain (%)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the Left Atrium Strain will be recorded

  11. Left Atrium Strain Rate (1/s)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the Left Atrium Strain Rate will be recorded

  12. Aortic Time- Velocity Integral (TVI) (cm)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the aortic TVI will be recorded

  13. Global Work Index (GWI) (mmHg%)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWI will be recorded

  14. Global Constructive Work (GCW) (mmHg%)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GCW will be recorded

  15. Global Wasted Work (GWW) (mmHg%)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWW will be recorded

  16. Segmental CW, WW at the mid septal wall

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and segmental WI, CW, WW at the mid septal wall will be recorded

  17. Segmental CW, WW at the basal lateral wall

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and segmental WI, CW, WW at the basal lateral wall will be recorded

  18. Peak Strain Dispersion (PSD) (msec)

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and PSD will be recorded

  19. Changes in capture threshold (V) in the ventricular lead

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    The device will be interrogated at baseline, 3 months, 6 months and one year after the procedure and the potential changes in capture threshold in the ventricular lead will be recorded

  20. Changes in sense (mV) in the ventricular lead

    Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

    The device will be interrogated at baseline, 3 months, 6 months and one year after the procedure and potential changes in sense in the ventricular lead will be recorded

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

Left Bundle Branch Pacing Versus Conventional Pacing in Patients With Atrioventricular Node Disorders: a Randomized, Control Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2021
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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