Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization (NCT05155865) | Clinical Trial Compass
CompletedNot Applicable
Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization
Slovenia62 participantsStarted 2022-01-10
Plain-language summary
Cardiac resynchronization therapy (CRT) with biventricular pacing (BiV) is the cornerstone treatment for heart failure patients with ventricular dyssynchrony. Recently, a new concept, conduction system pacing (CSP) with permanent pacing, including His bundle pacing and left bundle branch pacing, has been proposed as a potential alternative to conventional BiV-CRT. The prospective, randomized trial will compare echocardiographic, electrocardiographic, and clinical effects of CSP versus conventional BiV pacing in heart failure patients with reduced ejection fraction (LVEF ≤ 35%), sinus rhythm, and left bundle branch block. Patients will be randomized to either CSP or biventricular pacing study group and followed up for at least 6 months. The study will explore whether CSP is non-inferior to BiV pacing in echocardiographic, electrocardiographic, and clinical outcomes.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Sinus rhythm and complete left bundle branch block according to Strauss criteria
✓. LVEF ≤35%
✓. NYHA class II-III
✓. Optimal medical heart failure therapy for at least 3 months before enrollment
✓. The patient is able to understand and willing to provide a written informed consent
✓. 18 years of age or older
Exclusion criteria
✕. Mechanical tricuspid valve replacement
✕. More than moderate valvular disease
✕. Unstable angina, acute MI, CABG, or PCI within the past 6 months
✕. Persistent or permanent atrial fibrillation
✕. Ventricular arrhythmias (frequent PVC) which do not allow to acquire consecutive regular beats during echocardiography and electrocardiography
What they're measuring
1
Change in left ventricular volume
Timeframe: acute after the procedure, 1 month, 6 months, 12 months