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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure, Atrial Fibrillation

Intervention / Treatment
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* Device: CRT Device and Bi-ventricular pacing
* Device: CRT Device and His-bundle Pacing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBP Group<br>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<br>* Bi-ventricular pacing by a CRT device<br>Device: CRT Device and His-bundle Pacing<br>* His-bundle pacing by a CRT device through the pacing lead at His-bundle region<br>|
| Active Comparator: BiVP Group<br>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<br>* Bi-ventricular pacing by a CRT device<br>Device: CRT Device and His-bundle Pacing<br>* His-bundle pacing by a CRT device through the pacing lead at His-bundle region<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Atrial Fibrillation, CRT, BiVP, HBP