Heart FailureNCT02805465
Comparison of His Bundle Pacing and Bi-Ventricular Pacing in Heart Failure With Atrial Fibrillation
A study testing CRT Device and Bi-ventricular pacing and CRT Device and His-bundle Pacing in people with Heart Failure and Atrial Fibrillation, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Atrial Fibrillation
- What is being tested?
- CRT Device and Bi-ventricular pacing and CRT Device and His-bundle Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Weijian Huang, MD, +86 138-0669-1086, weijianhuang69@126.com
Lan Su, +86 137-3874-2616, 2512057600@qq.com
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Atrial Fibrillation
- Being tested
- CRT Device and Bi-ventricular pacing, CRT Device and His-bundle Pacing
- Keywords
- Heart Failure, Atrial Fibrillation, CRT, BiVP, HBP
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT Device and Bi-ventricular pacingDevice
Bi-ventricular pacing by a CRT device
CRT Device and His-bundle PacingDevice
His-bundle pacing by a CRT device through the pacing lead at His-bundle region
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CRT Device and Bi-ventricular pacing; Device: CRT Device and His-bundle Pacing |
| 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. Receives: Device: CRT Device and Bi-ventricular pacing; Device: CRT Device and His-bundle Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of LVEF(%) from baseline in HBP and BiV Group
Measured: 18 months
Secondary outcomes (10)
Change of 6min walking distance (m) from the baseline
Measured: 18 months
Change of LV end diastolic diameter(mm) from baseline
Measured: 18 months
Change of LV end systolic diameter(mm) from baseline
Measured: 18 months
The number of heart failure hospitalization after the procedure group
Measured: 18 months
Change of Quality of Life
The Short Form (36) Health Survey (SF-36) Questionnaire
Measured: 18 months
Change of Average sensing amplitude (V)
Measured: 18 months
Change of average pacing threshold (V)
Measured: 18 months
Change of average pacing impedance (ohm)
Measured: 18 months
Change of New York Heart Association (NYHA) Classification from baseline
Measured: 18 months
The number of patients with heart failure hospitalization after the procedure
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 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 Provincial People's Hospital
- Responsible party
- Principal investigator, Weijiang Huang, First Affiliated Hospital of Wenzhou Medical University
- Investigators
- Weijian Huang, MD, Principal investigator, Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805465
- Sponsor's protocol ID
- FirstWenzhouMU001
- Status last verified
- Jun 2016
- First submitted
- 30 May 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 35843465
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02805465
- Acronym / sponsor ID
- FirstWenzhouMU001
- Conditions
- Heart Failure, Atrial Fibrillation
- Keywords
- Heart Failure, Atrial Fibrillation, CRT, BiVP, HBP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- 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 Provincial People's Hospital
- Study start
- Jan 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBP Group | Experimental | Device: CRT Device and Bi-ventricular pacing, Device: CRT Device and His-bundle PacingCRT 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 | Device: CRT Device and Bi-ventricular pacing, Device: CRT Device and His-bundle PacingCRT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT Device and Bi-ventricular pacingBi-ventricular pacing by a CRT device | Device | BiVP Group, HBP Group |
| CRT Device and His-bundle PacingHis-bundle pacing by a CRT device through the pacing lead at His-bundle region | Device | BiVP Group, HBP Group |
Primary outcome
Change of LVEF(%) from baseline in HBP and BiV Group
Time frame: 18 months
10 secondary outcomes
Change of 6min walking distance (m) from the baseline
Time frame: 18 months
Change of LV end diastolic diameter(mm) from baseline
Time frame: 18 months
Change of LV end systolic diameter(mm) from baseline
Time frame: 18 months
The number of heart failure hospitalization after the procedure group
Time frame: 18 months
Change of Quality of Life
Time frame: 18 months
Change of Average sensing amplitude (V)
Time frame: 18 months
Change of average pacing threshold (V)
Time frame: 18 months
Change of average pacing impedance (ohm)
Time frame: 18 months
Change of New York Heart Association (NYHA) Classification from baseline
Time frame: 18 months
The number of patients with heart failure hospitalization after the procedure
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Derived from this study: PubMed 35843465Huang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weijian Huang, MD principal investigator
Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT Device and Bi-ventricular pacing and CRT Device and His-bundle Pacing in people with Heart Failure and Atrial Fibrillation, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weijian Huang, MD (+86 138-0669-1086, weijianhuang69@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of LVEF(%) from baseline in HBP and BiV Group (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016.