This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
During the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSite™ Precision™ mapping system and Advisor™ HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers.
During the device implant procedure, a VisionWire coronary guidewire will also be placed into a branch of coronary sinus (CS), targeting a lateral branch. This guidewire could be used for collecting local left ventricle (LV) activation time (Q-LV) or pacing the LV. This guidewire could also be used to deliver a LV lead at physician's discretion. This procedure might be part of the standard-of-care at the participating centers.
Tampa General Hospital
Tampa, Florida, United States
Successful HB pacing sites
Collect 3D Locations and electrogram characteristics (morphology and activation time) at the sites where His Bundle (HB) pacing is associated with left bundle recruitment and corrects electrical dyssynchrony at HB pacing implant procedure.
Time frame: At device implant procedure
Success rate of HB pacing
Measure success rate of HB pacing or HB plus Left ventricular (LV) pacing in the correction of electrical dyssynchrony at implant procedure;
Time frame: At device implant procedure
Ventricular activation during HB pacing
Collect ventricular activation times during HB pacing or HB plus LV pacing as compared with intrinsic rhythm and other pacing configurations at implant procedure;
Time frame: At device implant procedure
Echocardiographic measurements of LV ejection fraction
Collect echo measurements of LV ejection fraction at three-month follow-up visit
Time frame: At three-month follow-up
Echocardiographic measurements of LV end-systolic volume
Collect echo measurements of LV end-systolic volume at three-month follow-up visit
Time frame: At three-month follow-up
Capture threshold of HB pacing
Measure capture threshold in volts of HB pacing at implant and at follow-up visits post implant
Time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
Lead impedance of HB pacing lead
Measure lead impedance in ohms of HB pacing lead at implant and at follow-up visits post implant
Time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
Sensing amplitude of HB pacing lead
Measure sensing amplitude in millivolts of HB pacing lead at implant and at follow-up visits post implant
Time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
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