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

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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.


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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Huntsville, Alabama 35801
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Huntsville, AL
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