Last updated on February 2019

His Bundle Pacing Registry

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03719040

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