Randomized Trial of Left Bundle Branch vs Biventricular Pacing for Cardiac Resynchronization Therapy.
Yao Wang, Haojie Zhu, Xiaofeng Hou...
https://pubmed.ncbi.nlm.nih.gov/36137670Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06061627
A Randomized Controlled Trial of Left Bundle Branch Optimized Cardiac Resynchronization Therapy Versus Conventional Bi-ventricular Pacing in Heart Failure Patients With Nonspecific Intraventricular Conduction Delay
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-05-14
86
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying chronic heart failure patients who have a specific heart conduction problem called nonspecific intraventricular conduction delay (NICD). This randomized, controlled trial aims to compare the effects of a newer pacing method called left bundle branch area pacing combined with left ventricular pacing (LOT-CRT) against the traditional biventricular pacing (BiVP) method. The goal is to see which method better preserves heart function in patients with NICD over a follow-up period of at least six months. Participants will be randomly assigned to one of two groups. In the LOT-CRT group, patients receive a right atrial lead, an implantable cardioverter defibrillator lead, a left ventricular pacing lead, and a left bundle branch area pacing lead. The BiVP group receives the same leads except for the left bundle branch area pacing lead. The study will follow participants for a minimum of six months to compare the effects of these pacing methods on heart function and clinical outcomes. During the study, participants will undergo assessments including echocardiograms to measure left ventricular ejection fraction at baseline and six months. Other evaluations include paced QRS durations, heart function classifications, quality of life questionnaires, walking tests, blood tests for heart failure biomarkers, and monitoring of arrhythmias and hospitalizations. Researchers will also track the success rate of the left bundle branch area pacing implantation. Safety and clinical outcomes will be closely monitored throughout the study, which is expected to last over three years for recruitment and follow-up.
CONDITIONS
Brief Title
A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with ischemic or non-ischemic cardiomyopathy
- Receiving optimal medical therapy for at least 3 months
- Classified as NYHA class II to IV heart failure
- Left ventricular ejection fraction of 35% or less by echocardiography
- Sinus rhythm, may have paroxysmal atrial fibrillation
- QRS duration of 150 milliseconds or longer
- Nonspecific intraventricular conduction delay (NICD), not typical left or right bundle branch block
You will not qualify if you...
- Valvular heart disease requiring or having undergone surgical intervention
- Mechanical tricuspid valve replacement
- Persistent or permanent atrial fibrillation or atrial flutter
- Second or third degree atrioventricular block
- History of acute myocardial infarction within 3 months before enrollment
- Expected survival less than 12 months
- Pregnant or planning to conceive
- Ventricular septal hypertrophy with thickness over 15 mm at end diastole
- Presence of simple and persistent left superior vena cava
- Existing pacemaker implantation
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 months
Participants receive implantation of pacing leads either by conventional biventricular pacing or left bundle branch optimized cardiac resynchronization therapy (LOT-CRT), which includes left bundle branch area pacing combined with left ventricular epicardial pacing.
1 operative day and follow-up visits at 1 month, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
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Research Team
J
Jiangang Zou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Left bundle branch-optimized cardiac resynchronization therapy (LOT-CRT): Results from an international LBBAP collaborative study group.
Marek Jastrzębski, Paweł Moskal, Wim Huybrechts...
https://pubmed.ncbi.nlm.nih.gov/34339851