Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders (RESCUE)
Heart Failure, Left Bundle-Branch Block, Ischemic Cardiomyopathy
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy, Biventricular Pacing, Left Bundle Branch Pacing, Speckle Tracking Echocardiography, Biomarker of Fibrosis and Remodeling, Combined Left Bundle Branch and Left Ventricular Pacing, CRT Non-responder, CRT Responder
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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; Acute coronary syndrome; Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting); Patients listed for heart transplant; Patients with implanted cardiac assist device; Acute myocarditis; Infiltrative myocardial disease; Hypertrophic cardiomyopathy; Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves; Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age; Mental or physical inability to participate in the study; Patients unable or unwilling to cooperate within the study protocol; Patients with rheumatic heart disease; Mechanic tricuspid valve patients; Patients with any serious medical condition that could interfere with this study; Enrollment in another investigational drug or device study; Patients not available for follow-up; Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml/min/1.73 m2); Life expectancy ≤ 12 months; Participation in another telemonitoring concept.
Sites / Locations
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Cardiac Resynchronization Therapy with Biventricular Pacing
Cardiac Resynchronization Therapy with Left Bundle Branch Pacing
Cardiac Resynchronization Therapy with Combined Left Bundle Branch and Left Ventricular Pacing
Patients who are non-responders to biventricular cardiac resynchronization therapy (CRT) with indications to CRT devices with defibrillator function (CRT-D) or CRT-D leads replacement. CRT-D or CRT-D leads replacement will be performed in this group of patients.
Patients who are non-responders to biventricular cardiac resynchronization therapy (CRT) with indications to CRT devices with defibrillator function (CRT-D) or CRT-D leads replacement. CRT-D or CRT-D leads replacement with the new lead implantation to the left bundle branch and inactivation of conventional right and left ventricular pacing will be performed in this group of patients.
Patients who are non-responders to biventricular cardiac resynchronization therapy (CRT) with indications to CRT devices with defibrillator function (CRT-D) or CRT-D leads replacement. CRT-D or CRT-D leads replacement with the new lead implantation to the left bundle branch and inactivation of conventional right ventricular pacing will be performed in this group of patients.