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Outcomes and Safety of Various Conduction System Pacing Methods

NCT04749836 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-01-09

No results posted yet for this study

Summary

The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.

Conditions

  • AV Block
  • Bundle-Branch Block
  • Atrial Fibrillation Rapid

Interventions

PROCEDURE

His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing

Different active fixation leads and the dedicated delivery sheaths are introduced via standard transvenous approach under fluoroscopic guidance. His bundle potential mapping is performed in a unipolar setting with the use of the electrophysiological system for His bundle pacing. After localizing the His bundle potential, the pacing is attempted before the lead fixation to confirm HB capture. The lead is then screwed into position. Acute HBP threshold ≤ 2.5V at 1ms is considered acceptable. On the other hand, the initial site for LBBP is approximately 1-1.5 cm distal to the HBP lead position in the RV septum along the line between the HBP site and RV apex in the right anterior oblique (30°) fluoroscopic view. Bachmann bundle pacing (upper atrial septum) will be performed with the J-stylet modification technique or with specialized catheter method using the SelectSecure active fixation lead. Stepwise approach for conduction pacing will also be tested.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • David Žižek, Assist. Prof. · University Medical Centre Ljubljana

Eligibility

Min Age
5 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-04
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749836 on ClinicalTrials.gov