Comparison of His Bundle Pacing and Bi-Ventricular Pacing in Heart Failure With Atrial Fibrillation
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 30, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJune 20, 2016
June 1, 2016
2.5 years
May 30, 2016
June 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of LVEF(%) from baseline in HBP and BiV Group
18 months
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
HBP Group
EXPERIMENTALCRT 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 COMPARATORCRT 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.
Interventions
His-bundle pacing by a CRT device through the pacing lead at His-bundle region
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- First Affiliated Hospital of Wenzhou Medical Universitylead
- HT-Med Companycollaborator
- Chinese Academy of Medical Sciences, Fuwai Hospitalcollaborator
- Shanghai Zhongshan Hospitalcollaborator
- Jiangsu People's Hospitalcollaborator
- Wuhan Asia Heart Hospitalcollaborator
- Sir Run Run Shaw Hospitalcollaborator
- Shanxi People's Hospitalcollaborator
Study Sites (1)
First Affliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Related Publications (1)
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.
PMID: 35843465DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weijian Huang, MD
Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean of Cardiology, First Affiliated Hospital of Wenzhou Medical University
Study Record Dates
First Submitted
May 30, 2016
First Posted
June 20, 2016
Study Start
January 1, 2016
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
June 20, 2016
Record last verified: 2016-06