Atrial Fibrillation, Heart Failure
Conditions
Keywords
Heart Failure, Atrial Fibrillation, CRT, BiVP, HBP
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.
Interventions
DEVICECRT Device and Bi-ventricular pacing
Bi-ventricular pacing by a CRT device
DEVICECRT Device and His-bundle Pacing
His-bundle pacing by a CRT device through the pacing lead at His-bundle region
Sponsors
HT-Med Company
Chinese Academy of Medical Sciences, Fuwai Hospital
Shanghai Zhongshan Hospital
Jiangsu People's Hospital
Wuhan Asia Heart Hospital
Sir Run Run Shaw Hospital
Shanxi People's Hospital
First Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of LVEF(%) from baseline in HBP and BiV Group | 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 18 months | The Short Form (36) Health Survey (SF-36) Questionnaire |
| 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 | — |
Countries
China
Contacts
Primary ContactWeijian Huang, MD
Backup ContactLan Su, MD
Outcome results
None listed