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This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. Prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. Additional retrospective data collection includes procedural data during the HB pacing lead and device implant.
Up to 200 subjects will participate in this clinical investigation. The clinical investigation will be conducted at up to 8 centers worldwide.
The total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBP device data collection group | Device electrograms and 12-lead ECG will be collected from patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device during a standard-of-care device follow-up visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device data collection | Procedure | Collection of device electrograms and 12-lead ECG during a device follow-up visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amplitude of device electrogram | Mean amplitude of device electrogram during His bundle pacing | through study completion, an average of 1 year |
| Duration of device electrogram | Mean duration of device electrogram during His bundle pacing | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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The intended population for this clinical investigation consists of patients over the age of 18 years who have been previously implanted with a permanent His Bundle pacing lead and an Abbott pacemaker, defibrillator, or cardiac resynchronization therapy device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| *Heart Center Research, LLC. | Huntsville | Alabama | 35801 | United States | ||
| Donald Guthrie Foundation for Education & Research |
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| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| D054537 | Atrioventricular Block |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Sayre |
| Pennsylvania |
| 18840 |
| United States |
| Greenville Health System | Greenville | South Carolina | 29605 | United States |
| D006327 |
| Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |