NCT03803995

Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Failure
• Left Bundle-Branch Block

Interventions

Type	Name	Description
PROCEDURE	Mapping and Pacing the His Bundle	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.
PROCEDURE	Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing	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.

Timeline

• Start date: 2019-03-20
• Primary completion: 2024-04-20
• Completion: 2024-04-26
• First posted: 2019-01-15
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States