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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Bi-ventricular pacing by a CRT device
His-bundle pacing by a CRT device through the pacing lead at His-bundle region
First Affliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGChange of LVEF(%) from baseline in HBP and BiV Group
Time frame: 18 months
Change of 6min walking distance (m) from the baseline
Time frame: 18 months
Change of LV end diastolic diameter(mm) from baseline
Time frame: 18 months
Change of LV end systolic diameter(mm) from baseline
Time frame: 18 months
The number of heart failure hospitalization after the procedure group
Time frame: 18 months
Change of Quality of Life
The Short Form (36) Health Survey (SF-36) Questionnaire
Time frame: 18 months
Change of Average sensing amplitude (V)
Time frame: 18 months
Change of average pacing threshold (V)
Time frame: 18 months
Change of average pacing impedance (ohm)
Time frame: 18 months
Change of New York Heart Association (NYHA) Classification from baseline
Time frame: 18 months
The number of patients with heart failure hospitalization after the procedure
Time frame: 18 months
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