Comparing left bundle branch area pacing to traditional biventricular pacing for heart failure patients with atrial fibrillation
Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure ：A Multi-center Randomized Controlled Trial
This study is testing whether a new pacing method called left bundle branch area pacing can help heart failure patients with atrial fibrillation feel better compared to the traditional biventricular pacing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fu Wai Hospital, Beijing, China Academic / other |
| Locations | 5 sites (Beijing, Beijing and 4 other locations) |
| Trial ID | NCT05549544 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial aims to evaluate the clinical efficacy of left bundle branch area pacing (LBBAP) compared to traditional biventricular pacing (BiVP) in patients suffering from permanent atrial fibrillation and heart failure. The study will enroll adult patients with left ventricular ejection fraction (LVEF) less than 50% who require ventricular pacing. Participants will be randomized to receive either LBBAP or BiVP after device implantation, and their heart function will be assessed at 3 and 6 months post-discharge. The primary endpoint is the change in LVEF from baseline to 6 months.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with heart failure (LVEF <50%) and permanent atrial fibrillation requiring ventricular pacing.
Not a fit: Patients with a life expectancy of less than 12 months or those with prior mechanical tricuspid valve replacement may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved heart function and quality of life for patients with heart failure and atrial fibrillation.
How similar studies have performed: While the approach of LBBAP is gaining interest, this specific comparison with BiVP is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. 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 2. LVEF\<50%, NYHA II-IV, atrial fibrillation with slow ventricular rate, anticipated ventricular pacing burden ≥ 40% * Written informed consent was provided Exclusion Criteria: * 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
Where this trial is running
Beijing, Beijing and 4 other locations
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
- Peking University First Hospital — Beijing, Beijing, China (Not_yet_recruiting)
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
- The first affiliated hospital of Nanjing medical university — Nanjing, Jiangsu, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Xiaohan Fan, PhD — Chinese Academy of Medical Sciences, Fuwai Hospital
- Study coordinator: Haojie Zhu, M.D
- Email: 13167310573@163.com
- Phone: +8613167310573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.