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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pacing threshold |
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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
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Patients undergoing permanent pacemaker implantation identified by the TriHealth Heart Institute Electrophysiologists
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| Name | Affiliation | Role |
|---|---|---|
| Marshall Winner, MD | TriHealth Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TrIHealth | Cincinnati | Ohio | 45242 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |