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

Hospital Moinhos de Vento

Status: Active, not recruiting

Conditions: Conduction System Pacing; Left Bundle-Branch Block; Heart Failure; Cardiac Resynchronization

Treatments: Device: Conduction system pacing; Device: Biventricular pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT05572736

NUP: 25000.123471/2021-59

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

179 participants in 2 patient groups

Conduction system pacing

Experimental group

Description:

Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.

Treatment:

Device: Conduction system pacing

Biventricular pacing

Active Comparator group

Description:

Patients will be randomized 1:1 to either conduction system pacing or biventricular pacing.

Treatment:

Device: Biventricular pacing