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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04115735
Other study ID # 18-109
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 9, 2019
Est. completion date January 23, 2020

Study information

Verified date August 2023
Source TriHealth Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date January 23, 2020
Est. primary completion date January 23, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 105 Years
Eligibility 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

Study Design


Locations

Country Name City State
United States TrIHealth Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From beginning of procedure to the end
Secondary 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 From insertion of the pacing lead until successful measurement of HIS bundle
Secondary 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. From beginning of procedure to the end of procedure
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