Comparison of His Bundle Pacing and Bi-Ventricular Pacing in Heart Failure With Atrial Fibrillation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change of LVEF(%) from baseline in HBP and BiV Group [18 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is at least 18 years old
-
Subject or authorized legal guardian or representative has signed and dated the Informed
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Subject is expected to remain available for follow-up visits at the study center
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Subjects with heart failure NYHA Class II-IV
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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
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Subjects with mechanical right heart valve
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Subjects with primary valvular disease
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Subjects with heart transplant, or is currently on a heart transplant list
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affliated Hospital, Wenzhou Medical University | Wenzhou | Zhejiang | China | 325000 |
Sponsors and Collaborators
- First Affiliated Hospital of Wenzhou Medical University
- 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
Investigators
- Principal Investigator: Weijian Huang, MD, Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FirstWenzhouMU001