His Bundle Recording From Subclavian Vein

Overview

His bundle pacing has been proposed as a superior alternative to standard right ventricular pacing. The purpose of this study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. This would support the use of stylet driven leads for His bundle pacing.

Full Title of Study: “Obtaining His Bundle Recording From the Subclavian Vein in Patients Undergoing Permanent Pacemaker Implantation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2020

Detailed Description

The purpose of this prospective observational study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath can be done in a quick and reliable manner. Included in the study are patients undergoing permanent pacemaker implantation at Good Samaritan and Bethesda North Hospitals. The main outcome is successful recording of a His bundle potential. Secondary outcomes are the time necessary to record the His bundle and the measurement of the pacing threshold.

Clinical Trial Outcome Measures

Primary Measures

  • Successful recording of a His bundle potential
    • Time Frame: From beginning of procedure to the end
    • The pacing lead will be connected to a standard EP recording system (GE CardioLab, LS Pro, or EP Med) a copy of the intracardiac electrograms demonstrating His bundle recording will be saved electronically.

Secondary Measures

  • Time necessary to record the HIS bundle
    • Time Frame: From insertion of the pacing lead until successful measurement of HIS bundle
    • Both the procedural and fluoroscopy time from insertion of the pacing lead until successful measurement of the His bundle
  • Pacing threshold
    • Time Frame: From beginning of procedure to the end of procedure
    • Threshold will be measured in volts at 1 millisecond and recorded for selective His bundle capture, non-selective His bundle capture, and ventricular septal capture as appropriate for each patient. The measurement of a normal His Bundle threshold is < 2.0 V at 1.0 ms.

Participating in This Clinical Trial

Inclusion Criteria

Age ≥ 18 years Male or Female Patients undergoing HIS bundle recording from the subclavian vein using a stylet driven pacemaker lead and commercially available sheath Exclusion Criteria:

Patients who are unwilling or unable to sign the informed consent Pregnant women

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 105 Years

Investigator Details

  • Lead Sponsor
    • TriHealth Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marshall Winner, MD, Principal Investigator, TriHealth Heart Institute
  • Overall Contact(s)
    • Dominique Brandt, MS, MA, 513-852-8940, dominique_brandt@trihealth.com

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