NCT02805465

Comparison of His Bundle Pacing and Bi-Ventricular Pacing in Heart Failure With Atrial Fibrillation

Comparison of His Bundle Pacing (HBP) and Bi-Ventricular Pacing(BiVP) in Heart Failure (HF) Patients With Atrial Fibrillation (AF) Who Need Atrial-Ventricular Node (AVN) Ablation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, prospective, randomized cross-over study to compare His Bundle Pacing (HBP) with Bi-Ventricular Pacing (BiVP) in HF Patients with AF who need atrial-ventricular node ablation.

Detailed description

Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, both atrial-ventricular node(AVN) ablation and Cardiac Resynchronization Therapy (CRT) implantation are performed with HBP lead implanted and connected with the A port of CRT device. Followed with successful AVN ablation, HBP lead and CRT implantation, patients are 1:1 randomized into BiVP and HBP group for 9 months and then crossover for another 9 months. The primary end points of the study is the change of left ventricular ejection fraction (LVEF) in both HBP and BiV pacing group.

Conditions

• Heart Failure
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	CRT Device and Bi-ventricular pacing	Bi-ventricular pacing by a CRT device
DEVICE	CRT Device and His-bundle Pacing	His-bundle pacing by a CRT device through the pacing lead at His-bundle region

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2016-06-20
• Last updated: 2016-06-20

Locations

1 site across 1 country: China