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

Not Applicable

• Conditions: Heart Failure; Atrial Fibrillation
• Interventions: Device: CRT Device and Bi-ventricular pacing; Device: CRT Device and His-bundle Pacing

• Registration Number: NCT02805465
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

Brief 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-30
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-15
• Last Update Submitted: 2016-06-15
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-20
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Subject is at least 18 years old
• Subject or authorized legal guardian or representative has signed and dated the Informed
• Subject is expected to remain available for follow-up visits at the study center
• Subjects with heart failure NYHA Class II-IV
• Subjects with LVEF no greater than 40%
• Subjects with persistent atrial fibrillation or atrial flutter with uncontrolled ventricular rate

Exclusion Criteria

• Subjects with the width of ECG Q, R, S wave (QRS) complex >120ms
• Subjects with life expectancy less than 3 years
• Subjects with mechanical right heart valve
• Subjects with primary valvular disease
• Subjects with heart transplant, or is currently on a heart transplant list
• Subjects who are pregnant, or of childbearing potential and not on a reliable form of birth control
• Subjects with significant renal dysfunction, as manifested by serum creatinine level >2.5 mg/dl or ≥275 μmol/L or estimated glomerular filtration rate (GFR) ≤30 mL/min/1.72 m2, which is documented within the 30 days prior to enrollment or at baseline.
• Subjects with significant hepatic dysfunction, as evidenced by a hepatic function panel (serum) > 3 times upper limit of normal, which is documented within the 30 days prior to enrollment or at baseline.
• Subjects with chronic or treatment-resistant severe anemia (hemoglobin <10.0 g/dL), which is documented within the 30 days prior to enrollment or at baseline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HBP Group	CRT Device and Bi-ventricular pacing	CRT Device and His-bundle Pacing. Patients will get His-bundle pacing through a CRT device first for 9 months then switch to Bi-ventricular pacing by the same CRT device for another 9 months.
HBP Group	CRT Device and His-bundle Pacing	CRT Device and His-bundle Pacing. Patients will get His-bundle pacing through a CRT device first for 9 months then switch to Bi-ventricular pacing by the same CRT device for another 9 months.
BiVP Group	CRT Device and Bi-ventricular pacing	CRT Device and Bi-ventricular Pacing. Patients will get BiV pacing for 9 months through a CRT device then switch to His-bundle pacing by the same CRT device for another 9 months.
BiVP Group	CRT Device and His-bundle Pacing	CRT Device and Bi-ventricular Pacing. Patients will get BiV pacing for 9 months through a CRT device then switch to His-bundle pacing by the same CRT device for another 9 months.

Primary Outcome Measures

Name	Time	Method
Change of LVEF(%) from baseline in HBP and BiV Group	18 months

Secondary Outcome Measures

Name	Time	Method
Change of LV end systolic diameter(mm) from baseline	18 months
Change of average pacing threshold (V)	18 months
The number of patients with heart failure hospitalization after the procedure	18 months
Change of 6min walking distance (m) from the baseline	18 months
Change of LV end diastolic diameter(mm) from baseline	18 months
The number of heart failure hospitalization after the procedure group	18 months
Change of Average sensing amplitude (V)	18 months
Change of Quality of Life	18 months	The Short Form (36) Health Survey (SF-36) Questionnaire
Change of average pacing impedance (ohm)	18 months
Change of New York Heart Association (NYHA) Classification from baseline	18 months

Trial Locations

Locations (1)

First Affliated Hospital, Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China