Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure
LBBAP-AFHF
1 other identifier
interventional
60
1 country
5
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Typical duration for not_applicable
5 active sites
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
July 18, 2022
CompletedFirst Submitted
Initial submission to the registry
September 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 10, 2024
January 1, 2024
2.4 years
September 15, 2022
January 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ΔLVEF between baseline and six months post-discharge
ΔLVEF：change in LVEF between baseline and six months after procedure
Six months after device implantation
Secondary Outcomes (9)
The immediate success rate of the LBBAP procedure
1 weeks
The rate of procedure and Device related complications
6 months
ΔLVEDD between baseline and six months post-discharge
6 months
ΔLVEDV between baseline and six months post-discharge
6 months
The echocardiographic response rate of LVEF increase ≥5%
6 months
- +4 more secondary outcomes
Study Arms (2)
LBBAP group
EXPERIMENTALDevice: 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 COMPARATORDevice: 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.
Interventions
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 pacing is a widely-established modality to treat heart failure in patients with heart failure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037, China
Peking University First Hospital
Beijing, Beijing Municipality, 100037, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The first affiliated hospital of Nanjing medical university
Nanjing, Jiangsu, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaohan Fan, PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
September 15, 2022
First Posted
September 22, 2022
Study Start
July 18, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
January 10, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share