HBP Device EGM Data Collection
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/3/2019 |
Start Date: | July 17, 2018 |
End Date: | August 2019 |
Contact: | Wenwen Li, PhD |
Email: | wenwen.li@abbott.com |
Phone: | 408-522-6207 |
His Bundle Pacing Device Electrogram Data Collection
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Suspected pacing system failure
- Lead impedance out of range
- Ventricular sensing amplitude lower than 0.5 mV
We found this trial at
3
sites
Sayre, Pennsylvania 18840
Principal Investigator: Pramod Deshmukh, MD
Phone: 570-887-6071
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Greenville, South Carolina 29615
Principal Investigator: Andrew Brenyo, MD
Phone: 864-455-4551
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