His Bundle Recording From Subclavian Vein

Atrial Fibrillation Clinical Trial

Official title:

Obtaining His Bundle Recording From the Subclavian Vein in Patients Undergoing Permanent Pacemaker Implantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04115735
• Other study ID #: 18-109
• Status: Terminated
• 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
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Congestive Heart Failure
• Heart Failure

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