Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05760924

Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders

Led by Tomsk National Research Medical Center of the Russian Academy of Sciences · Updated on 2024-11-22

30

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with the increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of device for cardiac resynchronization therapy using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Cardiac conduction system pacing is currently a promising technique for these patients. Particularly, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has shown greater improvement in hemodynamic parameters comparing with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP, especially high pacing threshold. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to conventional biventricular CRT. Also, since 2019, left bundle branch pacing-optimized CRT (LBBPO CRT) has been used in clinical practice. These methods have become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS complex duration on electrocardiogram. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP and LBBPO CRT in patients with CRT indications. However, it is not enough data about impact of CRT with LBBP and combined CRT with LBBP and LV pacing on myocardial remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP and combined CRT with LBBP and LV pacing compared with conventional biventricular pacing will significantly improve the clinical outcomes and reverse myocardial remodeling in patients who are non-responders to biventricular CRT with HF, reduced LV ejection fraction and with indications to CRT devices with defibrillator function (CRT-D) or one of the CRT-D leads replacement.

CONDITIONS

Official Title

Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is willing and able to follow the study protocol and has provided written consent
  • Male or female patients aged 18 to 80 years
  • Patients diagnosed with ischemic or non-ischemic cardiomyopathy
  • Symptomatic heart failure for at least 3 months before joining the study
  • New York Heart Association (NYHA) heart failure class II or higher
  • Non-responders to biventricular CRT with heart failure and reduced left ventricular ejection fraction, needing CRT-D or CRT-D lead replacement
  • Receiving optimal heart failure medical therapy
Not Eligible

You will not qualify if you...

  • Coronary artery bypass surgery, balloon dilatation, or stenting within 3 months before joining
  • Acute heart attack or acute coronary syndrome within 3 months prior
  • Planned cardiovascular surgery or procedures
  • Listed for heart transplant
  • Implanted cardiac assist device
  • Acute myocarditis or infiltrative myocardial disease
  • Hypertrophic cardiomyopathy
  • Severe valve disease (mitral, tricuspid, or aortic)
  • Women currently pregnant, breastfeeding, or not using reliable contraception during fertile years
  • Mental or physical inability to participate
  • Unwilling or unable to cooperate with the study protocol
  • Rheumatic heart disease
  • Mechanical tricuspid valve
  • Any serious medical condition interfering with the study
  • Participation in another investigational 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

Tomsk, Russia

Actively Recruiting

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Research Team

T

Tariel A Atabekov, Ph.D.

CONTACT

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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