Clinical trial NCT02805465: Comparison of His Bundle Pacing and Bi-Ventricular Pacing in Heart Failure With Atrial Fibrillation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Atrial Fibrillation
Keywords: Heart Failure
Atrial Fibrillation
CRT
BiVP
HBP
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: HT-Med Company
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shanghai Zhongshan Hospital
name: Jiangsu People's Hospital
name: Wuhan Asia Heart Hospital
name: Sir Run Run Shaw Hospital
name: Shanxi People's Hospital
First posted: 2016-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of LVEF(%) from baseline in HBP and BiV Group
timeFrame: 18 months
Secondary outcomes:
measure: Change of 6min walking distance (m) from the baseline
timeFrame: 18 months
measure: Change of LV end diastolic diameter(mm) from baseline
timeFrame: 18 months
measure: Change of LV end systolic diameter(mm) from baseline
timeFrame: 18 months
measure: The number of heart failure hospitalization after the procedure group
timeFrame: 18 months
measure: Change of Quality of Life
timeFrame: 18 months
measure: Change of Average sensing amplitude (V)
timeFrame: 18 months
measure: Change of average pacing threshold (V)
timeFrame: 18 months
measure: Change of average pacing impedance (ohm)
timeFrame: 18 months
measure: Change of New York Heart Association (NYHA) Classification from baseline
timeFrame: 18 months
measure: The number of patients with heart failure hospitalization after the procedure
timeFrame: 18 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: First Affliated Hospital, Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
name: Weijian Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: