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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Atrial Fibrillation
• Intervention / Treatment: Device: CRT Device and Bi-ventricular pacing; Device: CRT Device and His-bundle Pacing

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weijian Huang, MD; Phone Number: +86 138-0669-1086; Email: weijianhuang69@126.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • First Affliated Hospital, Wenzhou Medical University
      • Contact: Weijian Huang, MD; Phone Number: +86 138-0669-1086; Email: weijianhuang69@126.com
      • Contact: Lan Su; Phone Number: +86 137-3874-2616; Email: 2512057600@qq.com
      • Sub-Investigator: Lan Su, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HBP Group; 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.	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
ACTIVE_COMPARATOR: BiVP Group; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of LVEF(%) from baseline in HBP and BiV Group	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Collaborators: Shanghai Zhongshan Hospital; Sir Run Run Shaw Hospital; Wuhan Asia Heart Hospital; Chinese Academy of Medical Sciences, Fuwai Hospital; Jiangsu People's Hospital; HT-Med Company; Shanxi People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (ESTIMATE): June 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Heart Failure; Atrial Fibrillation; CRT; BiVP; HBP
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: FirstWenzhouMU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED