Left Bundle Branch Area PacingLBBAP-AFHFNCT05549544
Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure
A study testing Left bundle branch area pacing and Biventricular pacing in people with Left Bundle Branch Area Pacing and Biventricular Pacing, run by Fu Wai Hospital, Beijing, China at 5 sites in China.
Trial summary
This is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Bundle Branch Area Pacing, Biventricular Pacing, Heart Failure
- What is being tested?
- Left bundle branch area pacing and Biventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesChina
- Study dates
- 18 Jul 2022to Dec 2024
- 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
- Adult patients aged more than 18 years old
- Patients diagnosed with heart failure (LVEF<50%) and have received optimal medical therapy for at least 3 months
- Patients with permanent atrial fibrillation (QRS duration <130ms) which need ventricular pacing, including:
- LVEF<50%, NYHA II-IV, drug-refractory atrial fibrillation with the fast ventricular rate, planned atrioventricular nodal ablation due to 1). anticipated low success rate of atrial fibrillation catheter ablation or 2). patients refused to receive catheter ablation or 3). refused to receive another catheter ablation after a previous history of failed procedures
- LVEF<50%, NYHA II-IV, atrial fibrillation with slow ventricular rate, anticipated ventricular pacing burden ≥ 40%
- Written informed consent was provided
Who cannot join
- expected survival time is less than 12 months
- Prior history of mechanical tricuspid valve replacement and/or congenital heart disease (including dextrocardia, transposition of the great arteries, single left persistent left superior vena cava, etc.)
- Plan for PCI or CABG due to unstable angina or myocardial infarction in 3 months
- Surgery is required within 1 year due to severe structural heart disease
- Pregnancy, planned pregnancy or heart transplant
- Prior history of HCM and/or ventricular septal defect repair, who are unlikely to achieve successful LBBAP procedure.
- Failure of lead placement due to abnormal anatomy of the coronary sinus or enlarged right atrium, which makes it unable to switch from one pacing modality to another
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Haojie Zhu, +8613167310573, 13167310573@163.com
Xiaofei Li, +8617801013995, lixiaofei0103@163.com
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100037
Jing Zhou
- Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Yangxin Chen
- Not yet recruiting
The first affiliated hospital of Nanjing medical university
Nanjing, Jiangsu
Jiangang Zou
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Ruiqin Xie, ruiqin_xie@sina.com
About this study
Official title: Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure ：A Multi-center Randomized Controlled Trial
This is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure
Read the detailed description
LBBAP-AFHF is a prospective, multicenter, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may show superiority of improved LV function as compared with traditional biventricular pacing (BiVP) in patients with permanent atrial fibrillation and heart failure (LVEF<50%) who receive atrioventricular nodal ablation due to fast ventricular rate or require high percentage of ventricular pacing due to slow ventricular rate. The primary endpoint of this trial is the change in the LVEF at 6 months after device implantation from baseline. A CRT-P/D device would be implanted and LBBAP lead would be connected to the RA port and LV lead to the LV port. Patients who receive successful LBBAP and BiVP simultaneously during the procedure would be 1:1 randomized to LBBAP or BiVP group after the procedure by device programming. Patients will be followed at 3 and 6 months post-discharge for LVEF and other echographic parameters (including LVESV, response rate), and rehospitalization for heart failure or all-cause death.
- Conditions
- Left Bundle Branch Area Pacing, Biventricular Pacing, Heart Failure, Permanent Atrial Fibrillation
- Being tested
- Left bundle branch area pacing, Biventricular pacing
- Keywords
- Left Bundle Branch Area Pacing, Permanent Atrial Fibrillation, Heart Failure, Biventricular Pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left bundle branch area pacingDevice
Left bundle branch area pacing is a novel physiological pacing modality and is reported to be feasible and safe in patients with heart failure and left bundle branch block.
Biventricular pacingDevice
Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure
| Study group | Role | What they receive |
|---|---|---|
| LBBAP group | Experimental | Device: Left bundle branch area pacing(LBBAP) LBBAP is a novel physiological pacing form for ventricular pacing. In patients who received LBBAP, the pacing lead will be placed at the left bundle branch area to achieve a narrow-paced QRS duration. Receives: Device: Left bundle branch area pacing |
| BiVP group | Active comparator | Device: Biventricular pacing (BiVP) Biventricular pacing is the traditional pacing modality for patients with heart failure. For BiVP, one pacing lead was placed in the coronary sinus, named LV lead, and another lead was placed in the right ventricule. Receives: Device: Biventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔLVEF between baseline and six months post-discharge
ΔLVEF：change in LVEF between baseline and six months after procedure
Measured: Six months after device implantation
Secondary outcomes (9)
The immediate success rate of the LBBAP procedure
Successful LBBAP procedure is identified according to ECG and intracardiac ECG electrogram (IEGM) during the procedure. All LBBAP procedures will be categorized as selective left bundle branch pacing (S-LBBP), non-selective left bundle branch pacing(NS-LBBP), or left ventricular septal pacing (LVSP).
Measured: 1 weeks
The rate of procedure and Device related complications
Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications
Measured: 6 months
ΔLVEDD between baseline and six months post-discharge
ΔLVEDD：change in LVEDD between baseline and six months after procedure between two groups
Measured: 6 months
ΔLVEDV between baseline and six months post-discharge
ΔLVEDV：change in LVEDV between baseline and six months after procedure between two groups
Measured: 6 months
The echocardiographic response rate of LVEF increase ≥5%
the percentage of patients with change of LVEF ≥5% at 6 month from baseline
Measured: 6 months
The changes of NT-proBNP betwen baseline and 6 months post-discharge
The changes of NT-proBNP betwen baseline and 6 months post-discharge
Measured: 6 months
Composite incidence rate of all-cause mortality and/or hospitalization for heart failure
All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.
Measured: 6 months
The echocardiographic response rate of LVEF increase ≥15%
an increase in LVESV ≥15% during follow-up at 6 month compared with baseline
Measured: 6 months
The rate of ΔLVESV ≥15% between baseline and six months post-discharge
the percentage of patients with change of ΔLVESV ≥15% at 6 month from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start18 Jul 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Bundle Branch Area PacingStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, The First Affiliated Hospital with Nanjing Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University First Hospital
- Responsible party
- Principal investigator, Xiaohan Fan, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiaohan Fan, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549544
- Sponsor's protocol ID
- 2022-1704
- Acronym
- LBBAP-AFHF
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure ：A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05549544
- Acronym / sponsor ID
- LBBAP-AFHF / 2022-1704
- Conditions
- Left Bundle Branch Area Pacing, Biventricular Pacing, Heart Failure, Permanent Atrial Fibrillation
- Keywords
- Left Bundle Branch Area Pacing, Permanent Atrial Fibrillation, Heart Failure, Biventricular Pacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fu Wai Hospital, Beijing, ChinaUniversity, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, The First Affiliated Hospital with Nanjing Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University First Hospital
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Sep 2022 (actual)
- 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 is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure
Detailed description
LBBAP-AFHF is a prospective, multicenter, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may show superiority of improved LV function as compared with traditional biventricular pacing (BiVP) in patients with permanent atrial fibrillation and heart failure (LVEF<50%) who receive atrioventricular nodal ablation due to fast ventricular rate or require high percentage of ventricular pacing due to slow ventricular rate. The primary endpoint of this trial is the change in the LVEF at 6 months after device implantation from baseline. A CRT-P/D device would be implanted and LBBAP lead would be connected to the RA port and LV lead to the LV port. Patients who receive successful LBBAP and BiVP simultaneously during the procedure would be 1:1 randomized to LBBAP or BiVP group after the procedure by device programming. Patients will be followed at 3 and 6 months post-discharge for LVEF and other echographic parameters (including LVESV, response rate), and rehospitalization for heart failure or all-cause death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBBAP group | Experimental | Device: Left bundle branch area pacingDevice: Left bundle branch area pacing(LBBAP) LBBAP is a novel physiological pacing form for ventricular pacing. In patients who received LBBAP, the pacing lead will be placed at the left bundle branch area to achieve a narrow-paced QRS duration. |
| BiVP group | Active comparator | Device: Biventricular pacingDevice: Biventricular pacing (BiVP) Biventricular pacing is the traditional pacing modality for patients with heart failure. For BiVP, one pacing lead was placed in the coronary sinus, named LV lead, and another lead was placed in the right ventricule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients aged more than 18 years old
- Patients diagnosed with heart failure (LVEF<50%) and have received optimal medical therapy for at least 3 months
- Patients with permanent atrial fibrillation (QRS duration <130ms) which need ventricular pacing, including:
- Written informed consent was provided
Key exclusion criteria (7 listed)
- expected survival time is less than 12 months
- Prior history of mechanical tricuspid valve replacement and/or congenital heart disease (including dextrocardia, transposition of the great arteries, single left persistent left superior vena cava, etc.)
- Plan for PCI or CABG due to unstable angina or myocardial infarction in 3 months
- Surgery is required within 1 year due to severe structural heart disease
- Pregnancy, planned pregnancy or heart transplant
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 |
|---|---|---|
| Left bundle branch area pacingLeft bundle branch area pacing is a novel physiological pacing modality and is reported to be feasible and safe in patients with heart failure and left bundle branch block. | Device | LBBAP group |
| Biventricular pacingBiventricular pacing is a widely-established modality to treat heart failure in patients with heart failure | Device | BiVP group |
Primary outcome
ΔLVEF between baseline and six months post-discharge
Time frame: Six months after device implantation
ΔLVEF：change in LVEF between baseline and six months after procedure
9 secondary outcomes
The immediate success rate of the LBBAP procedure
Time frame: 1 weeks
The rate of procedure and Device related complications
Time frame: 6 months
ΔLVEDD between baseline and six months post-discharge
Time frame: 6 months
ΔLVEDV between baseline and six months post-discharge
Time frame: 6 months
The echocardiographic response rate of LVEF increase ≥5%
Time frame: 6 months
The changes of NT-proBNP betwen baseline and 6 months post-discharge
Time frame: 6 months
Composite incidence rate of all-cause mortality and/or hospitalization for heart failure
Time frame: 6 months
The echocardiographic response rate of LVEF increase ≥15%
Time frame: 6 months
The rate of ΔLVESV ≥15% between baseline and six months post-discharge
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
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BIO|STREAM.CSP Study
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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.
Xiaohan Fan, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left bundle branch area pacing and Biventricular pacing in people with Left Bundle Branch Area Pacing and Biventricular Pacing, run by Fu Wai Hospital, Beijing, China at 5 sites 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 7 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 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Haojie Zhu, M.D (+8613167310573, 13167310573@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔLVEF between baseline and six months post-discharge (time frame: Six months after device implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2024.