HBP Device EGM Data Collection
Completed
Conditions studied: Sick Sinus Syndrome, AV Block, Heart Failure
In brief
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.
Key facts
- Study ID
- NCT03564860
- Run by
- Abbott Medical Devices
- People needed
- 200
- Starts
- 2018-07-17
- Expected to finish
- 2020-09-30
- Last updated by the study team
- 2020-10-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has previously implanted with Abbott device and any pacing lead at HB
- Age ≥ 18 years
- Ability to provide informed consent for study participation
- Willing to comply with study evaluation requirements
You may not qualify if…
- Suspected pacing system failure
- Lead impedance out of range
- Ventricular sensing amplitude lower than 0.5 mV
Where it is running
- *Heart Center Research, LLC. — Huntsville, Alabama, United States
- Donald Guthrie Foundation for Education & Research — Sayre, Pennsylvania, United States
- Greenville Health System — Greenville, South Carolina, United States
Full record on ClinicalTrials.gov
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