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: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: February 2020
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
- 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.
- 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
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
- Lead Sponsor
- TriHealth Inc.
- Provider of Information About this Clinical Study
- Overall Official(s)
- Marshall Winner, MD, Principal Investigator, TriHealth Heart Institute
- Overall Contact(s)
- Dominique Brandt, MS, MA, 513-852-8940, firstname.lastname@example.org
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.