Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure

Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure (PhysioSync-HF)

The purpose of this study is to evaluate the efficacy and safety of conduction system pacing versus biventricular pacing in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.

Inclusion criteria:

• Male or female, age ≥18 years
• Established diagnosis of symptomatic heart failure (New York Heart Association class II-III)
• Left ventricular ejection fraction ≤35% in prior 3 months
• Left bundle branch block (QRS ≥130 ms)
• Clinical indication for cardiac resynchronization therapy
• Patients should be clinically stable
• Patients should receive background standard of care for heart failure with reduced ejection fraction, with the maximum tolerated doses of ACE inhibitor or ARB or ARNI, beta-blocker, and mineralocorticoid receptor antagonist

Exclusion criteria:

• Life expectancy <12 months due to any disease
• Dementia or advanced cerebrovascular disease
• NYHA class IV
• Plan to implant an implantable cardioverter defibrillator (ICD), with or without resynchronization therapy (CRT-D)
• Enrollment in other clinical trials involving cardiac pacing
• Pregnancy or pre-menopausal women who do not use regular contraceptive methods
• Patients unable to understand and sign the consent for participation