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| Name | Class |
|---|---|
| HT-Med Company | UNKNOWN |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Jiangsu People's Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBP Group | Experimental | 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. |
|
| BiVP Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT Device and Bi-ventricular pacing | Device | Bi-ventricular pacing by a CRT device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of LVEF(%) from baseline in HBP and BiV Group | 18 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijian Huang, MD | Contact | +86 138-0669-1086 | weijianhuang69@126.com | |
| Lan Su, MD | Contact | +86 137-3874-2616 | 2512057600@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Weijian Huang, MD | Wenzhou 1st Affliated Hopsital, Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affliated Hospital, Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35843465 | Derived | Huang W, Wang S, Su L, Fu G, Su Y, Chen K, Zou J, Han H, Wu S, Sheng X, Chen X, Fan X, Xu L, Zhou X, Mao G, Ellenbogen KA, Whinnett ZI. His-bundle pacing vs biventricular pacing following atrioventricular nodal ablation in patients with atrial fibrillation and reduced ejection fraction: A multicenter, randomized, crossover study-The ALTERNATIVE-AF trial. Heart Rhythm. 2022 Dec;19(12):1948-1955. doi: 10.1016/j.hrthm.2022.07.009. Epub 2022 Jul 14. |
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| UNKNOWN |
| Wuhan Asia Heart Hospital | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Shanxi Provincial People's Hospital | OTHER_GOV |
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| CRT Device and His-bundle Pacing | Device | His-bundle pacing by a CRT device through the pacing lead at His-bundle region |
|
| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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