NCT03008291

His Bundle Pacing in Bradycardia and Heart Failure

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Yong-Mei Cha · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participants in this study will either have heart failure (HF) and are scheduled to undergo pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or left bundle area pacing (LBAP) (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders), or have atrioventricular (AV) block or bradycardia and are scheduled to undergo dual chamber pacemaker implantation. In this study additional heart rhythm measurements will be collected during the implant procedure to better understand how His bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of patients with HF or AV block. The hypothesis is that His bundle or parahisian pacing (HISP) and left bundle area pacing (LBAP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in functional bundle branch block or conduction delay in patients with heart failure (HF).

Conditions

• Bradycardia
• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	CRT-D Implantation	Cardiac resynchronization therapy defibrillator
PROCEDURE	CRT-P Implantation	Cardiac resynchronization therapy pacemaker
PROCEDURE	Dual Chamber Pacemaker Implantation

Timeline

• Start date: 2016-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2017-01-02
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States