NCT05760924Recruiting

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

Randomized Trial of Left Bundle Branch Pacing Effect on Clinical Outcomes and Left Ventricular Remodeling in Patients With Nonresponse to Biventricular Cardiac Resynchronization Therapy

Source: ClinicalTrials.gov · Last updated 22 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 30 (estimated)
First submitted: 22 Feb 2023
Start date: 1 Nov 2024
Primary completion date: 1 Jun 2028
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Diseases: Heart failure
NCT number: NCT05760924

What you commit to

Study type: Interventional
Planned participants: 30
From 1 Nov 2024 to the primary completion date, 1 Jun 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;
Acute myocardial infarction within 3 months prior to enrollment;
Enrollment in another investigational drug or device study;

Other illness

Acute coronary syndrome;
Patients listed for heart transplant;
Patients with implanted cardiac assist device;
Infiltrative myocardial disease;
Patients with rheumatic heart disease;
Patients with any serious medical condition that could interfere with this study;
Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml/min/1.73 m2);

Age

Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age;

Other

Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);
Acute myocarditis;
Hypertrophic cardiomyopathy;
Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves;
Mental or physical inability to participate in the study;
Patients unable or unwilling to cooperate within the study protocol;
Mechanic tricuspid valve patients;
Patients not available for follow-up;
Life expectancy ≤ 12 months;
Participation in another telemonitoring concept.

Who the study is looking for

The patient is willing and able to comply with the protocol and has provided written informed consent;
Male or female patients aged 18 to 80 years;
Patients with ischemic or non-ischemic cardiomyopathy;
Symptomatic HF for at least 3 months prior to enrollment in the study;
New York Heart Association (NYHA) functional class HF ≥ II;
Patients who are non-responders to biventricular CRT with HF, reduced LVEF and CRT-D replacement or one of the CRT-D leads replacement indications (without LVEF increase ≥ 5% and/or without a left ventricle end-systolic volume decrease ≥ 15% after CRT-D implantation at least 1 year old);
Optimal HF medical therapy.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences Coordinator of this site? Confirm its status	Tomsk	Russia	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.