His Bundle Recording From Subclavian Vein

TriHealth Inc.1 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Fibrillation Congestive Heart Failure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 105 Years

Medical Language ↔ Plain English

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

Locations (1)

TrIHealth

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Successful recording of a His bundle potential

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.

Time frame: From beginning of procedure to the end

Secondary Outcomes

Time necessary to record the HIS bundle

Both the procedural and fluoroscopy time from insertion of the pacing lead until successful measurement of the His bundle

Time frame: From insertion of the pacing lead until successful measurement of HIS bundle

Pacing threshold

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.

Time frame: From beginning of procedure to the end of procedure

Data from ClinicalTrials.gov

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