Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure
NCT ID: NCT05549544
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2022-07-18
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LBBAP group
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.
Left bundle branch area pacing
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.
BiVP group
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.
Biventricular pacing
Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure
Interventions
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Left bundle branch area pacing
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
Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The Second Hospital of Hebei Medical University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Peking University First Hospital
OTHER
Fu Wai Hospital, Beijing, China
OTHER
Responsible Party
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Xiaohan Fan
Professor, MD, PhD
Principal Investigators
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Xiaohan Fan, PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, 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
Countries
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Central Contacts
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Facility Contacts
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Jing Zhou
Role: primary
Yangxin Chen
Role: primary
Jiangang Zou
Role: primary
Other Identifiers
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2022-1704
Identifier Type: -
Identifier Source: org_study_id
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