His Bundle Pacing Registry



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:November 27, 2018
End Date:March 31, 2021
Contact:Jemymah C Morley
Email:jemymah.morley@abbott.com
Phone:+1 972-309-8503

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The His Bundle Pacing registry is a prospective, observational, multi-center registry
performed to gain a broader understanding of 1) the His bundle pacing (HBP) device implant
and follow-up workflows, including device and programmer measurements and 2) the clinical
utility in creating a 3-dimensional electro-anatomical map of the His bundle prior to device
implants based on the clinical site's routine care.

The HBP Registry will be conducted to gain a deeper understanding of the HBP device implant
and follow-up workflows. Additionally, the registry will provide a broader understanding of
the clinical utility in mapping the His bundle with the use of Abbott's EnSite Precision™
Cardiac Mapping System with an electrophysiology catheter prior to device implants for those
institutions where mapping is routine care prior to a HBP device implant.

The registry will include patients undergoing implantation of a pacemaker, defibrillator, or
a cardiac resynchronization therapy (CRT) pacemaker (CRT-P) or CRT defibrillator (CRT-D)
according to the clinical site's routine care. The registry will enroll up to 500 patients at
up to 50 sites worldwide and will collect data at implant and at 1 and 6 months post-implant.
Abbott's His bundle pacing delivery catheter will be included and evaluated in this registry
once approved by each participating country's regulatory body.

Inclusion Criteria:

- Scheduled for implantation of a de novo Abbott pacemaker, defibrillator, or CRT-P/D
device with a pacing lead located at the His bundle according to the clinical site's
routine care

- At least 18 years of age

- Willing and able to comply with the prescribed follow-up tests and schedule of
evaluations

- Provided written informed consent prior to any registry-related procedures

Exclusion Criteria:

- History of tricuspid valve repair or replacement

- Currently participating in another clinical study with an active treatment arm and
belong to the active arm

- Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the registry or to comply with follow-up
requirements, or impact the scientific soundness of the registry results

- Previous failed HBP implant

- Planned right-sided HBP implant

- Life expectancy of < 6 months

- Known contraindication for a HBP implant (i.e. ongoing infection, known inclusion of
the subclavian vein, etc.)
We found this trial at
2
sites
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
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mi
from
Sayre, PA
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