Actively Recruiting
Randomized Trial of Left Bundle Branch Pacing Effect on Clinical Outcomes and Left Ventricular Remodeling in Patients With Nonresponse to Biventricular Cardiac Resynchronization Therapy
Led by Tomsk National Research Medical Center of the Russian Academy of Sciences · Updated on 2024-11-22
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Heart failure (HF) is a common condition that increases with age and is linked to higher mortality, hospitalizations, and reduced quality of life. Cardiac resynchronization therapy (CRT) using biventricular pacing has been the standard treatment for HF patients with reduced left ventricular function and left bundle branch block (LBBB). However, about 30% of patients do not respond to conventional CRT, prompting investigation into alternative pacing methods such as His bundle pacing (HBP) and left bundle branch pacing (LBBP), with emerging evidence suggesting benefits from these newer techniques. This trial compares three approaches for patients who do not respond to conventional biventricular CRT and have indications for CRT devices with defibrillator function. One group will receive standard CRT-D device replacement, another will receive CRT-D replacement with new lead implantation for left bundle branch pacing (LBBP) while inactivating conventional right and left ventricular pacing, and the third group will have CRT-D replacement with LBBP lead implantation and continued left ventricular pacing but inactivation of right ventricular pacing. These procedures involve device pocket opening, lead assessments, and new lead implantation under local anesthesia. Participants will be followed for 24 months to assess outcomes such as all-cause mortality or worsening heart failure requiring hospitalization, heart function via left ventricular ejection fraction, exercise tolerance, and quality of life questionnaires. Researchers will monitor device activity, hospitalizations, and biomarker levels related to heart remodeling. The study aims to evaluate whether LBBP or combined LBB and left ventricular pacing improves clinical outcomes and heart remodeling compared to conventional CRT in non-responding HF patients.
CONDITIONS
Brief Title
Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to comply with the protocol and provide written informed consent
- Male or female patients aged 18 to 80 years
- Diagnosis of ischemic or non-ischemic cardiomyopathy
- Symptomatic heart failure for at least 3 months prior to enrollment
- New York Heart Association functional class II or higher
- Non-responders to biventricular CRT with reduced left ventricular ejection fraction and indication for CRT-D device or lead replacement
- Receiving optimal heart failure medical therapy
You will not qualify if you...
- Coronary artery bypass grafting, balloon dilatation, or stenting within 3 months prior to enrollment
- Acute myocardial infarction within 3 months prior to enrollment
- Acute coronary syndrome
- Planned cardiovascular interventions such as bypass grafting, balloon dilatation, or stenting
- Listed for heart transplant
- Implanted cardiac assist device
- Acute myocarditis
- Infiltrative myocardial disease
- Hypertrophic cardiomyopathy
- Severe primary stenosis or regurgitation of mitral, tricuspid, or aortic valves
- Woman currently pregnant, breastfeeding, or not using reliable contraception
- Mental or physical inability to participate
- Unable or unwilling to cooperate with study protocol
- Rheumatic heart disease
- Mechanical tricuspid valve
- Serious medical conditions interfering with study
- Enrollment in another investigational drug or device study
- Not available for follow-up
- Severe chronic kidney disease (eGFR ≤ 30 ml/min/1.73 m2)
- Life expectancy 12 months or less
- Participation in another telemonitoring program or concept
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants will undergo device replacement or implantation procedures under local anesthesia, involving the replacement of CRT-D devices or leads and possible implantation of new leads to the left bundle branch with adjustments to pacing settings.
1 procedure visit (in-person)
Duration - Up to 24 months
Participants receive cardiac resynchronization therapy with either conventional biventricular pacing, left bundle branch pacing, or combined left bundle branch and left ventricular pacing, depending on their assigned group.
Regular follow-up visits over 24 months
Duration - Up to 24 months
Participants are monitored for clinical outcomes including mortality, heart failure worsening, hospitalizations, device events, and cardiac function over the course of 24 months after treatment.
Periodic follow-up visits during 24 months
Trial Site Locations
Total: 1 location
1
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, Russia
Actively Recruiting
Research Team
T
Tariel A Atabekov, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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