His Bundle Recording From Subclavian Vein

Terminated

• Conditions: Congestive Heart Failure; Atrial Fibrillation

• Registration Number: NCT04115735
• Lead Sponsor: TriHealth Inc.

Brief 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.

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.

Study Timeline

• Study Start: 2019-09-09
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-04
• Primary Completion: 2020-01-23
• Study Completion: 2020-01-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful recording of a His bundle potential	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 Outcome Measures

Name	Time	Method
Time necessary to record the HIS bundle	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	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.

Trial Locations

Locations (1)

TrIHealth; 🇺🇸 Cincinnati, Ohio, United States